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The products listed on this page include some of the newest medical technology available. Each product listing contains information about what medical uses the device is approved for, when it can be used, and when it should not be used.  This information, along with information from your doctor and other sources, can help make you an informed participant in your health care.

List by Approval Date - List by Device Name - List by Category of Device

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

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