| Device Name | Category | Approv.Date | Links |
|---|
| TECNIS® Multifocal Foldable Silicone and Acrylic Intraocular Lenses |
Intraocular Lens (IOL) |
1/16/2009 |
![[Text]](https://webarchive.library.unt.edu/eot2008/20090201021025im_/http://www.fda.gov/cdrh/images/linker1.gif) |
| Express® SD Renal Monorail® Premounted Stent System |
Renal Stent |
12/11/2008 |
|
| E-LUMINEXX Vascular Stent |
Vascular |
12/4/2008 |
|
| BIOFINITY® (comfilcon A) Soft Contact Lens for Extended Wear |
Contact Lenses |
11/19/2008 |
|
| COBAS TaqMan HCV Test For Use With the COBAS AmpliPrep Instrument and the COBAS TaqMan Analyzer or the COBAS TaqMan 48 Analyzer |
Hepatitis C Test Kit |
10/30/2008 |
|
| Carotid WALLSTENT® Monorail® Endoprosthesis |
Stents |
10/23/2008 |
|
| Helios II Ablation Catheter |
Ablation Devices, Catheters |
10/8/2008 |
|
| Hoya iSpheric™ Model YA-60BB Intraocular Lens |
Intraocular Lens (IOL) |
9/26/2008 |
|
| Akreos® Posterior Chamber Intraocular Lens |
Intraocular Lens (IOL) |
9/5/2008 |
|
| COBAS TaqMan HBV Test For Use With The High Pure System |
Hepatitis |
9/4/2008 |
|
| T-SPOT.TB |
Tuberculosis |
7/25/2008 |
|
| XIENCE™ V Everolimus Eluting Coronary Stent on the Over-the-Wire (OTW) or Rapid Exchange (RX) Stent Delivery Systems |
Stents |
7/2/2008 |
|
| Invitrogen SPOT-Light® HER2 CISH™ Kit |
Breast Cancer |
7/1/2008 |
|
| EVOLENCE® Collagen Filler |
Wrinkle Fillers |
6/27/2008 |
|
| Medtronic® Attain StarFix™ Model 4195 Lead |
Pacemaker |
6/13/2008 |
|
| Talent™ Thoracic Stent Graft System |
Stents |
6/5/2008 |
|
| Zenith® TX2® Thoracic TAA Endovascular Graft with the H&LB One-Shot™ Introduction System |
Endovascular Grafts |
5/21/2008 |
|
| ELA Ovatio CRT-D System |
Ventricular Assist Device |
5/15/2008 |
|
| Stratos LV and Stratos LV T Cardiac Resynchronization Therapy Pacemakers and Corox OTW BP and Corox OTW S BP Left Ventricular Pacing Leads |
Pacemaker |
5/12/2008 |
|
| Thoratec HeartMate II LVAS |
Ventricular Assist Device |
4/21/2008 |
|
| Talent™ Abdominal Stent Graft System |
Endovascular Grafts |
4/15/2008 |
|
| CONTAK RENEWAL® 3 AVT® Models M150, M155, M157 and M159 |
Implantable Cardioverter Defibrillator |
3/13/2008 |
|
| FreeStyle Navigator® Continuous Glucose Monitoring System |
Glucose Monitoring |
3/12/2008 |
|
| Endeavor® Zotarolimus-Eluting Coronary Stent on the Over-the-Wire (OTW), Rapid Exchange (RX), or Multi Exchange II (MX2) Stent Delivery Systems |
Stents |
2/1/2008 |
|
| Dako TOP2A FISH pharmDx™ Kit |
Breast Cancer, Diagnostic Tests |
1/11/2008 |
|
| xTAG™ Respiratory Viral Panel (RVP) |
Assays |
1/3/2008 |
|
| ProDisc™-C Total Disc Replacement |
Spinal |
12/17/2007 |
|
| Zimmer NexGen® LPS-Flex Mobile and LPS-Mobile Bearing Knees |
Knee Prostheses |
12/10/2007 |
|
| ARCHITECT® CORE-M |
Hepatitis |
11/6/2007 |
|
| Epicel® cultured epidermal autograft (CEA) |
Humanitarian Use Devices |
10/25/2007 |
|
| Exponent® Self-Expanding Carotid Stent with Over-the-Wire (OTW) or Rapid-Exchange (RX) Delivery Systems |
Stents |
10/23/2007 |
|
| Mitroflow Aortic Pericardial Heart Valve |
Heart Valves |
10/23/2007 |
|
| REALIZE™ Band |
Gastric Banding |
9/28/2007 |
|
| AMPLATZER® Muscular VSD Occluder |
Occlusion Devices, Ventricular |
9/7/2007 |
|
| Femoral Introducer Sheath and Hemostasis Device (FISH™) |
Catheterization |
8/20/2007 |
|
| CryoCor Cryoablation |
Ablation Devices |
8/1/2007 |
|
| FLAIR Endovascular Stent Graft |
Stents |
7/23/2007 |
|
| GeneSearch™ BLN Test Kit |
In Vitro Diagnostics (IVD) |
7/16/2007 |
|
| PRESTIGE® Cervical Disc System |
Spinal |
7/16/2007 |
|
| VISX STAR S4 IR™ Excimer Laser System with Variable Spot Scanning (VSS™) and WaveScan WaveFront® System |
LASIK |
7/11/2007 |
|
| NOVATION™ Ceramic Articulation Hip System |
Hip Prostheses |
7/5/2007 |
|
| Cormet Hip Resurfacing System |
Hip Prostheses |
7/3/2007 |
|
| Binax Now® Malaria Test |
Test Kits |
6/13/2007 |
|
|
| INRange Remote Medication Management System |
Medication |
6/13/2007 |
|
| MONOLISA™ Anti-HBc IgM EIA |
Diagnostic Tests |
5/31/2007 |
|
| STS-7 Continuous Glucose Monitoring System |
Diabetes, Glucose Monitoring |
5/31/2007 |
|
| Mynx™ Vascular Closure System |
Vascular |
5/16/2007 |
|
| IMMULITE®/IMMULITE® 1000 and IMMULITE® 2000 Free PSA |
Prostate |
5/11/2007 |
|
| CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System |
Vascular |
5/8/2007 |
|
| EMS Swiss Dolorclast® |
Shock Wave Therapy |
5/8/2007 |
|
| C-flex™ intraocular lens |
Intraocular Lens (IOL) |
5/3/2007 |
|
| Perlane® Injectable Gel |
Wrinkle Fillers |
5/2/2007 |
|
| MONOLISA™ Anti-HBc EIA |
Hepatitis |
4/27/2007 |
|
| ACUITY™ Steerable Lead Models 4554, 4555, and 4556 |
|
4/13/2007 |
|
| Onyx® Liquid Embolic System (Onyx® HD-500) |
HDE |
4/11/2007 |
|
| IBI Therapy™ Cool Path™ Ablation Catheter and IBI 1500T9 RF Generator |
Ablation Devices |
3/16/2007 |
|
| INFUSE® Bone Graft |
Dental |
3/9/2007 |
|
| Paradigm REAL-Time and Guardian REAL-Time Systems |
Glucose Monitoring |
3/8/2007 |
|
| Histoacryl and Histoacryl Blue |
Glue |
2/16/2007 |
|
| MESOMARK™ |
Cancer |
1/24/2007 |
|
| Protégé® GPS™ and Protégé® RX Carotid Stent Systems |
Stents |
1/24/2007 |
|
| Radiesse (P050037) |
Wrinkle Fillers |
12/22/2006 |
|
| Radiesse (P050052) |
Wrinkle Fillers |
12/22/2006 |
|
| Cosmetic Tissue Augmentation Product |
Wrinkle Fillers |
12/20/2006 |
|
| Olympic Cool-Cap® |
|
12/20/2006 |
|
| The Spanner™ Temporary Prostatic Stent |
Prostate |
12/14/2006 |
|
| Allergan Inamed® Silicone-Filled Breast Implants |
Breast Implants |
11/17/2006 |
|
| Mentor MemoryGel™ Silicone Gel-Filled Breast Implants |
Breast Implants |
11/17/2006 |
|
| Paragon Z CRT® (tisilfocon A) Rigid Gas Permeable Contact Lenses for Corneal Refractive Therapy |
Contact Lenses |
11/16/2006 |
|
| Macroplastique® Implants |
Urinary Spincter |
10/30/2006 |
|
| ArteFill® |
Wrinkle Fillers |
10/27/2006 |
|
| NexStent® |
Stents |
10/27/2006 |
|
| syngo® Lung CAD |
Computed Tomography |
10/18/2006 |
|
| Arista™ AH Absorbable Hemostat |
Blood |
9/26/2006 |
|
| Cordis PRECISE™ OTW Nitinol Stent System |
Stents |
9/22/2006 |
|
| INTROL™ CF Panel I Control |
Cystic Fibrosis |
9/18/2006 |
|
| AxSYM CORE™ 2.0 |
Hepatitis |
9/8/2006 |
|
| ARCHITECT® HBsAg Assay |
Hepatitis |
9/7/2006 |
|
| AbioCor® Implantable Replacement Heart |
Heart Devices |
9/5/2006 |
|
| AxSYM CORE-M™ 2.0; AxSYM CORE-M™ 2.0 Controls |
Hepatitis |
8/25/2006 |
|
| MONOLISA™ Anti-HBs and MONOLISA™ Anti-HBs Calibrator Kit |
Hepatitis |
8/25/2006 |
|
| PRODISC®-L Total Disc Replacement |
|
8/14/2006 |
|
| Carl Zeiss Meditec MEL 80 Excimer Laser System |
LASIK |
8/11/2006 |
|
| Gore HELEX™ Septal Occluder |
Septal Occluders |
8/11/2006 |
|
| BIOTRONIK’s Kronos LV-T and Tupos LV/ATx Implantable Cardioverter Defibrillator Systems with Cardiac Resynchronization Therapy |
Defibrillators |
8/10/2006 |
|
| AxSYM® AUSAB® Reagent Kit, Calibrator and Controls |
Hepatitis |
8/7/2006 |
|
| Adept® Adhesion Reduction Solution (4% Icodextrin) |
Adhesion Prevention |
7/28/2006 |
|
| Fuji Computed Radiography Mammography Suite (FCRMS) |
Mammography |
7/10/2006 |
|
| Trilogy AB Acetabular System |
Acetabular Cup |
6/28/2006 |
|
| Zilver Vascular Stent |
Stents, Vascular |
6/26/2006 |
|
| Vitagel™ Surgical Hemostat |
Hemostat |
6/16/2006 |
|
| ARCHTECT® Anti-HCV |
Hepatitis C Test Kit |
6/7/2006 |
|
| Juvéderm Gel Implants |
Wrinkle Fillers |
6/2/2006 |
|
| ARCHITECT® AUSAB® Reagent Kit |
Hepatitis |
6/1/2006 |
|
| AxSYM® HBsAg Assay |
Hepatitis |
6/1/2006 |
|
| Stelkast Supass™ Acetabular System |
Hip Prostheses |
5/12/2006 |
|
| Birmingham Hip Resurfacing (BHR) System |
Hip Prostheses |
5/9/2006 |
|
| PhiCal™ Fecal Calprotectin Immunoassay |
Fecal |
4/26/2006 |
|
| Karl Storz Rigid TTTS Fetoscopy Instrument Set |
Fetal |
3/31/2006 |
|
| DexCom™ STS™ Continuous Glucose Monitoring System |
Glucose Monitoring |
3/24/2006 |
|
| LUMA™ Cervical Imaging System |
Cervical Cancer |
3/16/2006 |
|
| MonoPrep Pap Test |
Cervical Cancer |
3/3/2006 |
|
| Visian ICL™ |
Intraocular Lens (IOL) |
12/22/2005 |
|
| StarClose™ Vascular Closure System |
Catheterization |
12/21/2005 |
|
| Ceralas I Laser and Ceralink Slit Lamp Adapter |
Lasers |
12/20/2005 |
|
| VISTAKON® (senofilcon A) Contact Lens |
Contact Lenses |
12/20/2005 |
|
| C2a – Taper™ Acetabular System |
Hip Prostheses |
12/16/2005 |
|
| X STOP® Interspinous Process Decompression System |
Implants, Spinal |
11/21/2005 |
|
| GEM 21S (Growth-factor Enhanced Matrix) |
Bone Void Fillers, Dental |
11/18/2005 |
|
| IBI Therapy ™ Dual 8 ™ Ablation Catheter and IBI 1500T6 ( USA ) Generator |
Ablation Devices, Cardiac Ablation Devices |
11/18/2005 |
|
| Coaptite® |
Urinary Spincter |
11/10/2005 |
|
| STAN® S31 Fetal Heart Monitor |
Fetal, Heart Devices |
11/1/2005 |
|
| Total Temporomandibular Joint Replacement System |
Jaw Surgery, Prostheses |
9/21/2005 |
|
| ACRYSOF® Single-Piece Posterior Chamber Intraocular Lenses With Toric Optic, Models SA60T3, SA60T4 and SA60T5 |
Intraocular Lens (IOL) |
9/14/2005 |
|
| Xact® Carotid Stent System |
Stents |
9/6/2005 |
|
| Matrix VSG™ System |
Cardiac, Catheterization |
8/17/2005 |
|
| Orbasone Pain Relief System |
Heel Pain, Shock Wave Therapy |
8/10/2005 |
|
| SJM Biocor™ and Biocor™ Supra Valves |
Heart Valves |
8/5/2005 |
|
| SelectSecure™ Lead Model 3830 |
Lead Wires and Cables |
8/3/2005 |
|
| Wingspan™ Stent System with Gateway™ PTA Balloon Catheter |
Stents |
8/3/2005 |
|
| Onyx® Liquid Embolic System (LES) |
Embolizing Devices |
7/21/2005 |
|
| VNS Therapy System |
Stimulator |
7/15/2005 |
|
| DakoCytomation c-Kit pharmDx™ |
Gastrointestinal, Tumor |
6/27/2005 |
|
| GORE VIABAHN™ Endoprosthesis |
Stents |
6/14/2005 |
|
| ADVIA Centaur® HBsAg ReadyPack Reagents, ADVIA Centaur® HBsAg Confirmatory ReadyPack Reagents, and ADVIA Centaur® HBsAg Quality Control Material |
Hepatitis |
5/31/2005 |
|
| Wako LBA AFP-L3 |
Cancer |
5/19/2005 |
|
| Tag-It™ Cystic Fibrosis Kit |
Cystic Fibrosis |
5/9/2005 |
|
| Duraloc® Option Ceramic Hip System |
Ceramic, Hip Prostheses |
5/3/2005 |
|
| DakoCytomation Her2 FISH pharmDx™ Kit |
Breast Cancer |
5/3/2005 |
|
| Rithron-XR Coronary Stent System |
Stents |
4/29/2005 |
|
| Decapinol Oral Rinse |
Oral Rinse |
4/18/2005 |
|
| PAXgene™ Blood RNA System |
Genetic Tests |
4/18/2005 |
|
| Boston Scientific Liberte™ Monorail™ and Over-the-Wire Coronary Stent Systems |
Stents |
4/12/2005 |
|
| DuraSeal Dural Sealant System |
Sealants |
4/7/2005 |
|
| Orthospec™ Extracorporeal Shock Wave Therapy |
Acoustics |
4/1/2005 |
|
| CoAxia NeuroFlo™ Catheter |
Catheters |
3/30/2005 |
|
| Restylane™ Injectable Gel |
Wrinkle Fillers |
3/25/2005 |
|
| GORE TAG Thoracic Endoprosthesis |
Endovascular Grafts |
3/23/2005 |
|
| AcrySof® ReSTOR Apodized Diffractive Posterior Chamber Intraocular Lens (IOL) |
Intraocular Lens (IOL) |
3/21/2005 |
|
| ADVIA Centaur® HAV Total Assay |
Hepatitis |
3/7/2005 |
|
| UroVysion Bladder Cancer Kit |
Bladder Cancer, Test Kits |
1/24/2005 |
|
| IBI Therapy™ Cardiac Ablation System |
Cardiac Ablation Devices |
1/14/2005 |
|
| ADVIA Centaur® HBc Total ReadyPack Reagents, ADVIA Centaur® HBc Total Quality Control Materials |
Hepatitis |
12/27/2004 |
|
| Roche AmpliChip Cytochrome P450 Genotyping test and Affymetrix GeneChip Microarray Instrumentation System |
Genetic Tests |
12/23/2004 |
|
| ADVIA Centaur® HAV IgM |
Hepatitis |
12/22/2004 |
|
| Bayer ADVIA® Centaur™ HCV Assay |
Hepatitis, Hepatitis C Test Kit |
12/22/2004 |
|
| InSite™ Her-2/neu kit |
Breast Cancer |
12/22/2004 |
|
| Reflection® Ceramic Acetabular System |
Hip Prostheses |
12/17/2004 |
|
| URYX® Urethral Bulking Agent |
Urology |
12/16/2004 |
|
| Vysis® AutoVysion™ System |
Genetic Tests |
12/13/2004 |
|
| GORE VIATORR TIPS Endoprosthesis |
Stents |
12/6/2004 |
|
| Nuflexxa™ (1% Sodium Hyaluronate) |
Arthritis |
12/3/2004 |
|
| Kodak Mammography CAD ENGINE |
Mammography |
11/23/2004 |
|
| Biosense Webster NaviStar / Celsius ThermoCool Diagnostic/ Ablation Deflectable Tip Catheters |
Ablation Devices, Catheters |
11/5/2004 |
|
| Hamilton Thorne Zona Infrared Laser Optical System (ZILOS-tk®) |
Assisted Reproduction |
11/4/2004 |
|
| EVS™ Vascular Closure System |
Arteriotomy, Catheterization |
11/3/2004 |
|
| Endologix PowerLink® System |
Endovascular Grafts |
10/29/2004 |
|
| CHARITÉ™ Artificial Disc |
Artificial Discs |
10/26/2004 |
|
| ExAblate® 2000 System |
Fibroids, Uterus |
10/22/2004 |
|
| Syncardia Temporary CardioWest™ Total Artificial Heart (TAH-t) |
Heart |
10/15/2004 |
|
| JSZ Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear |
Contact Lenses |
9/29/2004 |
|
| Philips HeartStart Home OTC Defibrillator |
Automated External Defibrillators (AED), Cardiac |
9/16/2004 |
|
| Guidant Cardiac Resynchronization Therapy Defibrillators (COMPANION trial) |
Defibrillators |
9/14/2004 |
|
| ADVIA Centaur® Anti-HBs ReadyPack Reagents and Calibrators |
Hepatitis |
9/10/2004 |
|
| Verisyse™ Phakic IOL |
Intraocular Lens (IOL) |
9/10/2004 |
|
| ACCULINK™ and RX ACCULINK™ Carotid Stent System |
Stents |
8/30/2004 |
|
| NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit, Model MS-8970 |
|
8/24/2004 |
|
| Vertical Expandable Prosthetic Titanium Rib (VEPTR) |
Prostheses |
8/23/2004 |
|
| Siemens Mammomat Novation DM Full Field Digital Mammography System |
Mammography |
8/20/2004 |
|
| Ventana® Medical Systems' PATHWAY Anti-c-KIT (9.7) Primary Antibody |
|
8/11/2004 |
|
| ADVIA Centaur® HBc IgM ReadyPack Reagents, ADVIA Centaur® HBc IgM Quality Control (Calibrator and Control) Materials |
Hepatitis |
8/6/2004 |
|
| Sculptra |
Skin Fillers, Wrinkle Fillers |
8/3/2004 |
|
| CEDIA® Sirolimus Assay |
Test Kits |
7/28/2004 |
|
| INTACS® Prescription Inserts for Keratoconus |
Corneal Inserts |
7/26/2004 |
|
| Stelid II, Stelix, and Stelix II steroid eluting endocardial pacing leads |
Pacing Systems |
7/17/2004 |
|
| bioMerieux VIDAS total PSA assay |
PSA |
7/8/2004 |
|
| ImageChecker® CT CAD Software System |
Computed Tomography, Lung Cancer |
7/8/2004 |
|
| St. Jude Medical® Epic™ HF and Atlas® + HF Dual Chamber Implantable Cardioverter Defibrillator Systems with Cardiac Resynchronization Therapy |
Cardioverter, Defibrillators, Implantable Cardioverter Defibrillator |
6/30/2004 |
|
| IntraStent® DoubleStrut™ Stent |
Stents |
6/8/2004 |
|
| Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear |
Contact Lenses |
6/7/2004 |
|
| Glucatell™ |
Fungal Infections |
5/21/2004 |
|
| St. Jude Medical Frontier™ Biventricular Cardiac Pacing System |
Pacing Systems |
5/13/2004 |
|
| INFUSE® Bone Graft |
Bone Graft |
4/30/2004 |
|
| Oculaid™ Capsular Tension Ring, or Stableyes™ Capsular Tension Ring |
Cataracts, Intraocular Lens (IOL) |
4/27/2004 |
|
| PRECISION Spinal Cord Stimulator (SCS) System |
Spinal, Stimulator |
4/27/2004 |
|
| Hylaform |
Skin Fillers, Wrinkle Fillers |
4/22/2004 |
|
| Oxford™ Meniscal Unicompartmental Knee System |
Knee Prostheses |
4/21/2004 |
|
| OP-1 Putty |
Spinal, Spinal Fusion |
4/7/2004 |
|
| TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System |
Stents |
3/4/2004 |
|
| Vitros Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Vitros Immunodiagnostic Products Anti-HBc IgM Calibrator |
Hepatitis |
3/4/2004 |
|
| Vitros Immunodiagnostic Products Anti-HBc Reagent Pack and Vitros Immunodiagnostic Products Anti-HBc Calibrator |
Hepatitis |
3/4/2004 |
|
| DeBakey VAD® Child |
Ventricular Assist Device |
2/25/2004 |
|
| Heartsbreath |
Heart Devices |
2/24/2004 |
|
| Prolieve™ |
Benign Prostatic Hyperplasia (BPH), Microwaves |
2/19/2004 |
|
| DakoCytomation EGFR pharmDx™ |
In Vitro Diagnostics (IVD) |
2/12/2004 |
|
| Abbott AxSYM® Antibody to Hepatitis C Virus |
Hepatitis |
2/5/2004 |
|
| AxSym® Free PSA |
Prostate, Prostate Cancer, PSA |
2/5/2004 |
|
| Orthovisc® High Molecular Weight Hyaluronan |
Sodium Hyaluronate |
2/4/2004 |
|
| CONTAK® RENEWAL™ TR Models H120 and H125 |
Pacemaker |
1/26/2004 |
|
| CellSearch™ Epithelial Cell Kit / CellSpotter™ Analyzer |
Breast Cancer |
1/21/2004 |
|
| CoSeal™ Surgical Sealant |
Sealants |
12/12/2003 |
|
| Restylane™ Injectable Gel |
Wrinkle Fillers |
12/12/2003 |
|
| Keramos™ Ceramic/Ceramic Total Hip System |
Hip Prostheses |
11/26/2003 |
|
| Contegra® Pulmonary Valved Conduit, Models 200 (unsupported) and 200S (supported) |
Heart Valves |
11/21/2003 |
|
| NIRflex™ Premounted Coronary Stent System |
Stents |
10/24/2003 |
|
| Morcher Endocapsular Tension Ring |
Intraocular Lens (IOL) |
10/23/2003 |
|
| WaveLight ALLEGRETTO WAVE™ Excimer Laser System |
Lasers |
10/13/2003 |
|
| WaveLight ALLEGRETTO WAVE™ Excimer Laser System |
LASIK |
10/7/2003 |
|
| Microwave Endometrial Ablation (MEA) System |
Ablation Devices, Endometrial, Microwaves |
9/23/2003 |
|
| Blazer II XP Cardiac Ablation Catheter, EPT-1000 XP Cardiac Ablation Controller and Accessories |
Cardiac Ablation Devices, Catheters |
8/25/2003 |
|
| INDEPENDENCE™ iBOT™ 3000 Mobility System |
Wheelchairs |
8/13/2003 |
|
| S.M.A.R.T.™ Nitinol Stent System and S.M.A.R.T.™ Control™ Nitinol Stent System |
Stents |
8/12/2003 |
|
| MULTI-LINK VISION™ RX & OTW Coronary Stent System |
Angioplasty, Cardiac Angioplasty Devices, Catheters, Stents |
7/16/2003 |
|
| FX miniRAIL™ RX Percutaneous Transluminal Coronary Angioplasty PTCA Catheter |
Angioplasty, Cardiac Angioplasty Devices, Catheters |
6/11/2003 |
|
| ThinPrep™ Imaging System |
Cervical Cancer, Cervical Cytology, Computer Aided Diagnosis (CADx) |
6/6/2003 |
|
| Zenith AAA Endovascular Graft |
Aneurysm Repair Devices, Endovascular Grafts |
5/23/2003 |
|
| Response™ CV Catheter System |
Cardiac, Catheters |
5/7/2003 |
|
| CYPHER™ Sirolimus-eluting Coronary Stent |
Stents |
4/24/2003 |
|
| Enteryx Procedure Kit |
Gastroesophageal Reflux Disease (GERD) |
4/22/2003 |
|
| 7F Freezor® Cardiac Cryoablation Catheter and CCT.2 CryoConsole System |
Cardiac Ablation Devices |
4/17/2003 |
|
| Medtronic Activa® Dystonia Therapy |
Stimulator |
4/15/2003 |
|
| Digene Hybrid Capture 2 High-Risk HPV DNA Test |
HPV - Human Papillomavirus |
3/31/2003 |
|
| Bayer Versant™ HCV RNA 3.0 Assay (bDNA) |
Hepatitis, Hepatitis C Test Kit |
3/28/2003 |
|
| FemCap |
Barrier Devices, Contraceptives |
3/28/2003 |
|
| Medtronic AT500TM DDDRP Pacing System |
Pacemaker |
3/26/2003 |
|
| NeedleZap |
Hypodermic Needles, Needles, Sharps |
3/14/2003 |
|
| CosmoDerm™ 1 Human-Based Collagen, CosmoDerm™ 2 Human-Based Collagen and CosmoPlast™ Human-Based Collagen |
Collagen, Scarring, Wrinkle Fillers |
3/11/2003 |
|
| Ceramic TRANSCEND® Hip Articulation System |
Hip Prostheses |
2/3/2003 |
|
| Osteonics® ABC System and Trident™ System |
Hip Prostheses |
2/3/2003 |
|
| Dimension® Free Specific Antigen (FPSA) Flex® Reagent Cartridge |
Prostate, PSA |
1/24/2003 |
|
| Philips Series 50 XMO Fetal/Maternal Monitor (Model M1350C) with Integrated Fetal Oxygen Saturation Monitoring |
Fetal Oxygen |
1/3/2003 |
|
| ProstaLund® CoreTherm™ |
Benign Prostatic Hyperplasia (BPH), Prostate, Prostate Cancer |
12/23/2002 |
|
| Bridge™ Extra Support Over-The-Wire Renal Stent System |
Angioplasty, Balloon, Renal Stent |
12/18/2002 |
|
| Metrika A1cNow® for Home Use |
Diabetes |
12/13/2002 |
|
| Karl Storz Autofluorescence System |
Autofluorescence, Bronchoscopes |
12/12/2002 |
|
| ALERT® System |
Defibrillators |
11/27/2002 |
|
| Elecsys® proBNP Immunoassay |
Congestive Heart Failure |
11/19/2002 |
|
| IDI-Strep B Assay |
In Vitro Diagnostics (IVD), Strep B Assay |
11/18/2002 |
|
| VERSANT™ HCV RNA Qualitative Assay |
Hepatitis |
11/7/2002 |
|
| EXCLUDER™ Bifurcated Endoprosthesis |
Aneurysm Repair Devices |
11/6/2002 |
|
| HeartMate® SNAP-VE LVAS |
Heart Devices, Ventricular, Ventricular Assist Device |
11/6/2002 |
![[PDF]](https://webarchive.library.unt.edu/eot2008/20090201021025im_/http://www.fda.gov/cdrh/images/linker2.gif) |
| Essure™ System |
Contraceptives |
11/4/2002 |
|
| NaviStar DS and Celsius DS Diagnostic/Ablation Catheters, Stockert 70 RF Generator and Accessories |
Cardiac Ablation Devices |
9/27/2002 |
|
| Neuroform™ Microdelivery Stent System |
Aneurysm Repair Devices, Stents |
9/11/2002 |
|
| GlucoWatch G2 Biographer |
Diabetes, Glucose Monitoring, Glucowatch |
8/26/2002 |
|
|
| RetroX Transcutaneous Air Conduction Hearing Aid System |
Hearing Aids |
8/20/2002 |
|
| NEUROLINK® System |
Balloon, Catheters, Stents |
8/9/2002 |
|
| IMMULITE HBsAg and IMMULITE 2000 HBsAg and Confirmatory Kit |
Hepatitis |
7/26/2002 |
|
| IMMULITE® Anti-HBc IgM and IMMULITE® 2000 Anti-HBc IgM |
Hepatitis |
7/26/2002 |
|
| IMMULITE® Anti-HBc and IMMULITE® 2000 Anti-HBc |
Hepatitis |
7/24/2002 |
|
| IMMULITE® Anti-HBs and IMMULITE® 2000 Anti-HBs |
Hepatitis |
7/22/2002 |
|
| Mentor Saline-Filled Testicular Prosthesis |
Testicular Prostheses |
7/19/2002 |
|
|
| Siemens SONOCUR® Basic |
Elbow, Extracorporeal, Shock Wave Therapy |
7/19/2002 |
|
| Guidant Ventak Implantable Cardioverter Defibrillators - Expanded Use |
Defibrillators, Implantable Cardioverter Defibrillator |
7/18/2002 |
|
| PALMAZ® Balloon-Expandable Stent for Renal Arteries |
Angioplasty, Balloon |
7/10/2002 |
|
|
| InFUSE™ Bone Graft/LT-CAGE™ Lumbar Tapered Fusion Device |
Back Pain, Bone Graft Substitute, Spinal Fusion |
7/2/2002 |
|
|
| Medtronic® InSync® ICD Model 7272 Dual Chamber Implantable Cardioverter Defibrillator System with Cardiac Resynchronization Therapy |
Defibrillators, Implantable Cardioverter Defibrillator |
6/26/2002 |
|
| AFFINITY™ Cage System |
Orthopedic |
6/13/2002 |
|
|
| Paragon CRT™ (paflufocon B), Paragon CRT™ 100 (paflufocon D), Paragon Quadra RG™ (paflufocon B), and Paragon Quadra RG™ 100 (paflufocon D) Rigid Gas Permeable Contact Lenses for Corneal Refractive Therapy |
Contact Lenses, Eye |
6/13/2002 |
|
| Roche Diagnostics Accu-Check Advantage Module |
Glucose Monitoring |
6/11/2002 |
|
|
| TheraSense, Inc. FreeStyle Tracker™ Diabetes Management System |
Glucose Monitoring |
6/11/2002 |
|
|
| Indermil™ Tissue Adhesive |
Glue |
5/22/2002 |
|
|
| Guidant Cardiac Resynchronization Therapy Defibrillator System |
Defibrillators, Implantable Cardioverter Defibrillator |
5/2/2002 |
|
|
| Ancure® Aortoiliac System |
Endovascular Grafts |
4/24/2002 |
|
|
| INTEGRA® Dermal Regeneration Template |
Burns, Collagen, Dermal, Skin |
4/19/2002 |
|
| ViewPoint CK System |
Eye Surgery, Lasers |
4/11/2002 |
|
|
| IntraCoil® Self-Expanding Peripheral Stent |
Stents |
4/3/2002 |
|
|
| QuickSeal Arterial Closure System |
Heart, Heart Devices, Sealants |
3/25/2002 |
|
|
| Disintegrator Insulin Needle Destruction Unit |
Needles, Sharps |
3/15/2002 |
|
|
| Lorad Digital Breast Imager |
Breast Imaging Devices, Digital Mammography |
3/15/2002 |
|
|
| Lea's Shield |
Contraceptives, Women's Health |
3/14/2002 |
|
|
| SIR-Spheres® |
Cancer, Radioactive Spheres |
3/5/2002 |
|
|
| Elecsys Anti-HBs Immunoassay and Elecsys PreciControl Anti-HBs |
Hepatitis |
2/27/2002 |
|
|
| Wartner Wart Removal System |
Wart Removal |
2/20/2002 |
|
|
| Second Look™ |
Breast Imaging Devices, Digital Mammography |
1/31/2002 |
|
|
| Dornier Epos Ultra |
Shock Wave Therapy |
1/15/2002 |
|
|
| MammoReader |
Breast Imaging Devices, Mammography |
1/15/2002 |
|
|
| Activa® Parkinson's Control System |
Brain Stimulator, Movement Disorders, Parkinson's Disease, Stimulator |
1/14/2002 |
|
|
| VISX Excimer Laser System and Custom Contoured Ablation Pattern (C-CAP) Method |
Excimer Lasers |
12/19/2001 |
|
|
| Acticon™ Neosphincter |
Artificial Sphincter |
12/18/2001 |
|
|
| LIFECOR Wearable Cardioverter Defibrillator (WCD®) 2000 System |
Defibrillators |
12/18/2001 |
|
|
| CoSealTM Surgical Sealant |
Sealants |
12/14/2001 |
|
|
| AMPLATZER® Septal Occluder |
Cardiac, Heart, Heart Devices |
12/5/2001 |
|
|
| NNMT Medical, Inc. CardioSEAL Septal Occlusion System with QwikLoad |
Septal Occluders |
12/5/2001 |
|
|
| BioGlue Surgical Adhesive |
Glue |
12/3/2001 |
|
|
| QuantiFERON® -TB |
Tuberculosis |
11/28/2001 |
|
|
| Genesis Neurostimulation (IPG) System |
Stimulator |
11/21/2001 |
|
|
| Ascension MCP |
Finger Joint Implant, Orthopedic |
11/19/2001 |
|
|
| Gynecare Intergel Adhesion Prevention Solution |
Adhesion Prevention, Ob/Gyn, Ob/Gyn Surgical Devices |
11/16/2001 |
|
|
| WALLSTENT Venous Endoprosthesis with Unistep |
Cardiac |
11/16/2001 |
|
|
| IMMULITE AFP and IMMULTE 2000 AFP |
Alpha-Fetoprotein |
11/9/2001 |
|
|
| OP-1 TM Implant |
Bone Implant, Collagen |
10/17/2001 |
|
|
| Focus Night and Day Soft Contact Lens |
Contact Lenses |
10/11/2001 |
|
|
| Home Monitoring System with the BA03 DDDR Pulse Generator |
Pacemaker, Pacing Systems |
10/11/2001 |
|
|
| DERMAGRAFT |
Skin, Skin Substitutes, Wound Healing Devices |
9/28/2001 |
|
|
| NovaSure™ Impedance Controlled Endometrial Ablation System |
Ablation Devices, Endometrial |
9/28/2001 |
|
| SenoScan Full Field Digital Mammography System |
Mammography |
9/25/2001 |
|
|
| Deflux Injectable Gel |
Urology, Vesicoureteral Reflux |
9/24/2001 |
|
|
| Model 3100B High-Frequency Oscillatory Ventilator |
Ventilators |
9/24/2001 |
|
|
| SOUNDTEC® Direct Drive Hearing System |
Hearing Devices |
9/7/2001 |
|
|
| OrCel Bilayered Cellular Matrix |
Wound and Burn Dressing |
8/31/2001 |
|
|
| Vitros Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator |
Hepatitis |
8/30/2001 |
|
|
| Avanta Metacarpophalangeal (MCP) Joint Implant Finger Prosthesis |
Finger Joint Implant, Prostheses |
8/28/2001 |
|
|
| Medtronic InSync Biventricular Pacing System including the InSync Model 8040 Pulse Generator, Attain LV Model 2187 and Attain CS Model 2188 Leads |
Pacemaker, Pacing Systems |
8/28/2001 |
|
|
| MED-EL COMBI 40+ Cochlear Implant System |
Hearing Devices |
8/20/2001 |
|
|
| Given Diagnostic Imaging System |
Camera, Diagnostic Imaging, Endoscopy |
8/1/2001 |
|
|
| UBIS 5000 Ultrasound Bone Sonometer |
Bone Sonometers, Orthopedic, Ultrasound |
7/17/2001 |
|
|
| AquaFlow Collagen Glaucoma Drainage Device - Model CGDD-20 |
Glaucoma Devices |
7/12/2001 |
|
|
| RapidScreen RS-2000 |
Computer Aided Diagnosis (CADx), Lung Cancer, X-ray Equipment and Procedures |
7/12/2001 |
|
|
| Integrity AFx DR Model 5346 |
Pacemaker, Pacing Systems |
7/11/2001 |
|
|
| AMPLICOR Hepatitis C Virus (HCV) Test, version 2.0 (v2.0) |
Hepatitis |
7/5/2001 |
|
|
| Dimension RxL PSA Flex Reagent Cartridge |
Prostate, PSA |
7/5/2001 |
|
|
| COBAS AMPLICOR Hepatitis C Virus (HCV) Test, version 2.0 (v2.0) |
Hepatitis |
7/3/2001 |
|
|
| TMx-2000 BPH Thermotherapy System |
Microwaves, Prostate |
6/29/2001 |
|
|
| Carisolv Non-Invasive Caries Removal System |
Dental Composites |
6/27/2001 |
|
|
| Diagnostic Products Corporation’s Total Prostate Specific Antgen (PSA) Assays on the Immulite and Immulite 2000 Analyzers |
Prostate |
6/19/2001 |
|
|
| AMS Sphincter 800™ Urinary Prosthesis |
Incontinence, Prostate, Prostate Surgery |
6/14/2001 |
|
|
| LAP-Band® Adjustable Gastric Banding (LAGB®) System |
Gastric Banding, Lap-Band, Obesity, Stomach Band, Weight Loss Devices |
6/5/2001 |
|
|
| Elecsys HBsAg Immunoassay, Elecsys HBsAg Confirmatory, and PreciControl HBsAg |
Hepatitis |
6/1/2001 |
|
|
| On-X Prosthetic Heart Valve |
Heart, Heart Devices, Heart Valves |
5/30/2001 |
|
|
| Heartstream FR2 AED with Attenuated Defibrillation Pads |
Automated External Defibrillators (AED), Defibrillators |
5/2/2001 |
|
|
| Vitros Immunodiagnostic Products HBsAg Reagent Pack and Calibrator, and HBsAg Confirmatory Kit |
Hepatitis |
4/27/2001 |
|
|
| BAK/Cervical (BAK/C) Interbody Fusion System |
Orthopedic, Spinal Fusion |
4/20/2001 |
|
|
| HerOption Uterine Cryoblation Therapy System |
Ablation Devices, Cryoblation |
4/20/2001 |
|
|
| Hydro ThermAblator |
Ablation Devices, Endometrial |
4/20/2001 |
|
|
| STAARVISC Sodium Hyaluronate |
Eye Surgery, Sodium Hyaluronate |
4/18/2001 |
|
|
| Medtronic Model 7250 Jewel AF Implantable Cardioverter Defibrillator System (supplement) |
Defibrillators |
4/6/2001 |
|
|
| CeeOn Edge Foldable Ultraviolet Light-Absorbing Posterior Chamber Intraocular Lens - Model 911A |
Intraocular Lens (IOL) |
4/5/2001 |
|
|
| Devices for Testing the Hepatitus B Virus (HBV) |
Diagnostic Tests, Hepatitis |
3/30/2001 |
|
|
| PROSTALAC Hip Temporary Prosthesis |
Hip Prostheses |
3/23/2001 |
|
|
| GlucoWatch Automatic Glucose Biographer |
Blood Glucose Monitors, Diabetes, Glucose Monitoring, Glucowatch |
3/22/2001 |
|
|
| N Latex Cystatin C Test Kit |
Cystatin C, Diagnostic Tests, In Vitro Diagnostics (IVD) |
3/13/2001 |
|
|
| Edwards Prima Plus Stentless Bioprosthesis Model 2500P |
Heart, Heart Devices, Heart Valves |
2/27/2001 |
|
|
| TMJ Fossa Eminence Prosthesis |
Jaw Surgery, Temporomandibular Joint, Temporomandibular Joint (TMJ) Implants |
2/27/2001 |
|
|
| Composite Cultured Skin (CCS) |
Collagen, Skin, Skin Grafts, Wound Healing Devices |
2/21/2001 |
|
|
| VISTAKON (lenefilcon A) Soft Contact Lenses |
Contact Lenses |
2/16/2001 |
|
|
| Corometrics 120 F-Series Maternal/Fetal Monitor with Integrated Fetal Oxygen Saturation Monitoring |
Fetal Oxygen, Monitors |
2/9/2001 |
|
|
| SUPARTZ Dispo |
Sodium Hyaluronate |
1/24/2001 |
|
|
| TMJ (Temporomandibular Joint) Metal-on-Metal Total Joint Replacement Prostheses System |
Temporomandibular Joint (TMJ) Implants |
1/5/2001 |
|
|
| Microny SR+ Cardiac Pacemaker (Model 245T) |
Pacemaker, Pacing Systems |
12/21/2000 |
|
|
| Q-103 Needle Management System |
Anti-Needlestick Devices, Diabetes, Glucose Monitoring, Hypodermic Needles, Needles, Sharps |
12/21/2000 |
|
|
| Roche Elecsys free Prostate-Specific Antigen (fPSA) Assay on the Elecsys 1010 and 2010 immunoassay analyzers |
Analyzer Systems, Prostate, Prostate Cancer, PSA |
12/12/2000 |
|
|
| Psychemedics Corporation Opiate Assay |
Diagnostic Tests, Drugs of Abuse, Test Kits |
12/11/2000 |
|
|
| Stinger Ablation Catheter and TempLink Extension Cable |
Cardiac Ablation Devices, Catheters |
11/29/2000 |
|
|
| PATHWAY ™ Her 2 (Clone CB11) |
Cancer, In Vitro Diagnostics (IVD) |
11/28/2000 |
|
|
| Roche Elecsys Total Prostate-Specific Antigen (PSA) Assay on the 1010 and 2010 immunoassay analyzers |
Analyzer Systems, Prostate, Prostate Cancer, PSA |
11/22/2000 |
|
|
| Optical Biopsy System |
Biopsy Devices, Cancer |
11/14/2000 |
|
|
| Cordis Checkmate System |
Angioplasty, Brachytherapy, Cardiac Angioplasty Devices, Heart, Heart Devices, Restenosis |
11/3/2000 |
|
|
| Novoste Beta-Cath System |
Angioplasty, Brachytherapy, Cardiac Angioplasty Devices, Heart, Heart Devices, Restenosis |
11/3/2000 |
|
|
| Photon DR Implantable Cardioverter Defibrillator |
Defibrillators, Implantable Cardioverter Defibrillator |
10/27/2000 |
|
| Nucleus 24 Auditory Brainstem Implant System |
Auditory Implant, Brain Stimulator, Hearing Devices, Stimulator |
10/20/2000 |
|
|
| BeStent™ 2 with Discrete Technology™ Over-The-Wire and Rapid Exchange Coronary Stent Delivery Systems |
Angioplasty, Cardiac Angioplasty Devices, Stents |
10/16/2000 |
|
|
| ATS Open Pivot Bileaflet Heart Valve |
Heart, Heart Devices, Heart Valves |
10/13/2000 |
|
|
| OssaTron |
Orthopedic, Shock Wave Therapy |
10/12/2000 |
|
|
| BiodivYsio AS PC (phosphorylcholine) Coated Stent Delivery System |
Stents |
9/29/2000 |
|
|
| Phylax AV Implantable Cardioverter Defibrillator with Program Software |
Defibrillators, Heart, Heart Devices, Implantable Cardioverter Defibrillator |
9/29/2000 |
|
|
| Vitros Immunodiagnostic Products Anti-HBs Reagent Pack and Calibrators |
Calibrators, In Vitro Diagnostics (IVD) |
9/29/2000 |
|
|
| TRUFILL® n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System |
Embolization, Occlusion Devices |
9/25/2000 |
|
|
| DTU-One Ultrasound Scanner |
Bone Sonometers |
9/19/2000 |
|
|
| Bayer Immuno 1 Complexed Prostate-Specific Antigen (PSA) Assay - P990055 |
Analyzer Systems, Prostate, PSA |
9/8/2000 |
|
|
| Medstone STS Lithotripter |
Lithotripters |
9/5/2000 |
|
|
| Vibrant Soundbridge |
Hearing Devices |
8/31/2000 |
|
|
| Horizon 55 EW and Horizon 55 EW Westint Contact Lenses |
Contact Lenses |
8/22/2000 |
|
|
| QUS-2 Calcaneal Ultrasonometer |
Bone Sonometers |
8/8/2000 |
|
|
| Medtronic IsoMed Constant Flow Infusion System |
Infusion, Infusion Pumps, Pumps |
7/21/2000 |
|
|
| Mentor Alpha I Inflatable Penile Prosthesis |
Penile Devices |
7/14/2000 |
|
|
| Mosaic Porcine Bioprosthesis, Model 305 (Aortic) and Model 310 (Mitral) |
Heart Valves |
7/14/2000 |
|
|
| Menicon Z (tisilfocon A) Rigid Gas Permeable Contact Lens |
Contact Lenses |
7/11/2000 |
|
|
| Diomed 630 PDT Laser Model T2USA |
Cancer, Lasers |
6/30/2000 |
|
|
| Hyperion LTK System |
Eye Surgery, Lasers |
6/30/2000 |
|
|
| Vascular Solutions Duett Sealing Device |
Balloon, Sealants |
6/22/2000 |
|
|
| NAVI-STAR Diagnostic/Ablation Deflectable Tip Catheter |
Cardiac Ablation Devices, Catheters, Heart, Heart Devices, Radiofrequency Ablation |
6/15/2000 |
|
|
| Medtronic Model 7250 Jewel AF Implantable Cardioverter Defibrillator System |
Defibrillators, Implantable Cardioverter Defibrillator |
6/14/2000 |
|
|
| CoStasis/DynaStat Surgical Hemostat |
Hemostat |
6/13/2000 |
|
|
| Stocker 70 RF Generator |
Cardiac Ablation Devices, Radiofrequency Ablation |
5/31/2000 |
|
|
| FocalSeal-Synthetic Absorbable Sealant |
Sealants |
5/26/2000 |
|
|
| OxiFirst Fetal Oxygen Saturation Monitoring System |
Fetal Oxygen, Monitors, Oxygen |
5/12/2000 |
|
|
Recently Approved Devices
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