VISX Excimer Laser System and Custom Contoured Ablation Pattern (C-CAP) Method™ - H000002
|
Laser
|
12/19/01
|
Acticon™ Neosphincter - P010020
|
Sphincter
|
12/18/01
|
LIFECOR Wearable Cardioverter Defibrillator (WCD®) 2000 System - P010030
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Defibrillator
|
12/18/01
|
CoSeal® Surgical Sealant - P010022
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Vascular Sealant
|
12/14/01
|
AMPLATZER® Septal Occluder - P000039
|
Septal Occluder
|
12/05/01
|
NNMT Medical, Inc. CardioSEAL® Septal Occlusion System with QwikLoad™ - P000049
|
Septal Occluders
|
12/05/01
|
CryoLife BioGlue Surgical Adhesive - P010003
|
Skin Adhesive
|
12/03/01
|
QuantiFERON® -TB - P010033
|
TB Test
|
11/28/01
|
Genesis Neurostimulation (IPG) System - P010032
|
Stimulator
|
11/21/01
|
Ascension® MCP - P000057
|
Finger Joint Prosthesis
|
11/19/01
|
GYNECARE INTERGEL® Adhesion Prevention Solution - P990015
|
Adhesion Prevention
|
11/16/01
|
WALLSTENT® Venous Endoprosthesis with Unistep™ Plus Delivery System - P980033
|
Stent
|
11/16/01
|
IMMULITE® AFP and IMMULITE® 2000 AFP - P010007
|
Alpha-Fetoprotein Test
|
11/09/01
|
OP-1™ - H010002
|
Bone Implant
|
10/17/01
|
Focus® Night and Day Soft Contact Lens - P010019
|
Contact Lens
|
10/11/01
|
Home Monitoring System with the BA03 DDDR Pulse Generator - P950037/S19
|
Pacemaker
|
10/11/01
|
DERMAGRAFT® - P000036
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Skin Repair
|
09/28/01
|
NovaSure™ Impedance Controlled Endometrial Ablation System - P010013
|
Ablation Devices
|
09/28/01
|
SenoScan® Full Field Digital Mammography System - P010017
|
Mammography
|
09/25/01
|
IDeflux® Injectable Gel - P000029
|
Urinary Bulking Agent
|
09/24/01
|
Model 3100B High-Frequency Oscillatory Ventilator - P890057/S014
|
Ventilator
|
09/24/01
|
SOUNDTEC® Direct Drive Hearing System - P010023
|
Hearing Aid
|
09/07/01
|
OrCel™ Bilayered Cellular Matrix - P010016
|
Skin Repair
|
08/31/01
|
Vitros Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator - P010021
|
Hepatitis Test
|
08/30/01
|
Avanta Metacarpophalangeal (MCP) Joint Implant Finger Prosthesis - H010001
|
Finger Joint Prosthesis
|
08/28/01
|
Medtronic® InSync® Biventricular Pacing System including the InSync ®Model 8040 Pulse Generator, Attain™ LV Model 2187 and Attain ™CS Model 2188 Leads - P010015
|
Pacemaker
|
08/28/01
|
MED-EL COMBI 40+ Cochlear Implant System - P000025
|
Cochlear Implant
|
08/20/01
|
Given® Diagnostic Imaging System - K010312
|
Camera
|
08/01/01
|
UBIS 5000 Ultrasound Bone Sonometer - P000055
|
Bone Ultrasound
|
07/17/01
|
AquaFlow™ Collagen Glaucoma Drainage Device - Model CGDD-20 - P000026
|
Glaucoma Device
|
07/12/01
|
RapidScreen™ RS-2000 - P000041
|
Computer Aided Diagnosis
|
07/12/01
|
INTEGRITY™ AFx DR MODEL 5346 / P880086/S083 (Generator) & P830045/S076 (Programmer)
|
Pacemaker
|
07/11/01
|
AMPLICOR™ Hepatitis C Virus (HCV) Test, version 2.0 (v2.0) P000010
|
Hepatitis Test
|
07/05/01
|
Dimension RxL PSA Flex Reagent Cartridge - P000021
|
PSA Test
|
07/05/01
|
COBAS AMPLICOR™ Hepatitis C Virus (HCV) Test, version 2.0 (v2.0) P000012
|
Hepatitis Test
|
07/03/01
|
TMx-2000™ BPH Thermotherapy System - P000043
|
Microwave Therapy
|
06/29/01
|
Carisolv Non-Invasive Caries Removal System - P000005
|
Dental Treatment
|
06/27/01
|
Diagnostic Products Corporation's Total Prostate Specific Antgen (PSA) Assays on the Immulite and Immulite 2000 Analyzers - P930027/S4
|
PSA Test
|
06/19/01
|
AMS Sphincter 800™ Urinary Prosthesis - P000053
|
Sphincter
|
06/14/01
|
LAP-BAND® Adjustable Gastric Banding (LAGB®) System - P000008
|
Obesity Treatment
|
06/05/01
|
Elecsys® HBsAg Immunoassay, Elecsys® HBsAg Confirmatory, and PreciControl HBsAg- P990012
|
Hepatitis Test
|
06/01/01
|
On-X® Prosthetic Heart Valve - P000037
|
Heart Valve
|
05/30/01
|
Heartstream FR2 AED with Attenuated Defibrillation Pads K003819
|
Automated External Defibrillator (AED)
|
05/02/01
|
Vitros Immunodiagnostic Products HBsAg Reagent Pack and Calibrator, and HBsAg Confirmatory Kit - P000044
|
Hepatitis Test
|
04/27/01
|
BAK/Cervical (BAK/C®) Interbody Fusion System - P980048
|
Spinal Implant
|
04/20/01
|
HerOption™ Uterine Cryoblation Therapy™ System - P000032
|
Ablation Device
|
04/20/01
|
STAARVISC™ Sodium Hyaluronate - P000046
|
Eye Implant
|
04/18/01
|
Medtronic Model 7250 Jewel®AF Implantable Cardioverter Defibrillator System - P980050/S1
|
Defibrillator
|
04/06/06
|
CeeOn™ Edge Foldable Intraocular Lens - Model 911A - P990080
|
Intraocular Lens (IOL)
|
04/05/01
|
Devices For Testing The Hepatitis B Virus (HBV)
|
Hepatitis Test
|
03/30/01
|
Prostalac Hip Temporary Prosthesis - H000004
|
Hip Prosthesis
|
03/23/01
|
GlucoWatch® Automatic Glucose Biographer - P990026
|
Glucose Monitors
|
03/22/01
|
N Latex Cystatin C Test Kit - K003503
|
Kidney Test
|
03/13/01
|
Edwards Prima™ Plus Stentless Bioprosthesis Model 2500P - P000007
|
Heart Valve
|
02/27/01
|
TMJ Fossa Eminence Prosthesis™ - P000035
|
Jaw Prosthesis
|
02/27/01
|
Composite Cultured Skin - H990013
|
Skin Repair
|
02/21/01
|
VISTAKON (lenefilcon A) Soft Contact Lenses - P990085
|
Contact Lens
|
02/16/01
|
Corometrics 120 F-Series Maternal/Fetal Monitor with Integrated Fetal Oxygen Saturation Monitoring - P000016
|
Fetal Monitor
|
02/09/01
|
SUPARTZ™ DISPO- P980044
|
Arthritis Treatment
|
01/24/01
|
TMJ (Temporomandibular Joint) Metal-on-Metal Total Joint Replacement Prostheses System - P000023
|
Jaw Prosthesis
|
01/05/01
|