|
Microny SR+ Cardiac Pacemaker (Model 245T) - P970013
|
Pacemaker
|
12/21/00
|
|
Q-103 Needle Management System - P980020
|
Needle Destruction Device
|
12/21/00
|
|
Roche Elecsys free Prostate-Specific Antigen (fPSA) Assay on the Elecsys 1010 and 2010 immunoassay analyzers (P000027) (Revised 2/28/01)
|
PSA Test
|
12/12/00
|
|
Psychemedics Corporation Opiate Assay - K000851
|
Drugs of Abuse Test
|
12/11/00
|
|
Stinger™ Ablation Catheter and TempLink™ Extension Cable - P000020
|
Ablation Catheter
|
11/29/00
|
|
PATHWAY™ Her 2 (Clone CB11) - P990081
|
Breast Cancer Test
|
11/28/00
|
|
Roche Elecsys Total Prostate-Specific Antigen (PSA) Assay on the 1010 and 2010 - p990056 (Revised 2/28/2001)
|
PSA Test
|
11/22/00
|
|
Optical Biopsy™ System
|
Colonoscopy Device
|
11/14/00
|
|
Cordis Checkmate™ System - P990036
|
Angioplasty Device
|
11/03/00
|
|
Novoste™ Beta-Cath™ System - P000018
|
Angioplasty Device
|
11/03/00
|
|
Photon™ DR Implantable Cardioverter Defibrillator
|
Defibrillator
|
10/27/00
|
|
Nucleus 24 Auditory Brainstem Implant System - P000015
|
Hearing Implant
|
10/20/00
|
|
BeStent™ 2 with Discrete Technology™ Over-the-Wire and Rapid Exchange Coronary Stent Delivery Systems - P000022
|
Stent
|
10/16/00
|
|
ATS Open Pivot® Bileaflet Heart Valve
|
Heart Valve
|
10/13/00
|
|
OssaTron - P990086
|
Shock Wave Therapy
|
10/12/00
|
|
BiodivYsio™AS PC (phosphorylcholine) Coated Stent Delivery System - P000011
|
Stent
|
09/29/00
|
|
Phylax AV Implantable Cardioverter Defibrillator System with Programmer Software - P000009
|
Defibrillator
|
09/29/00
|
|
Vitros Immunodiagnostic Products Anti-HBs Reagent Pack and Calibrators - P000014
|
Hepatitis Test
|
09/29/00
|
|
TRUFILL® n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System
|
Embolizing Device
|
09/25/00
|
|
DTU-One Ultrasound Scanner - P980010
|
Bone Ultrasound
|
09/19/00
|
|
Bayer Immuno 1™ Complexed Prostate-Specific Antigen (PSA) Assay- P990055
|
PSA Test
|
09/08/00
|
|
Medstone STS™ Lithotripter - P970042
|
Shock Wave Therapy
|
09/05/00
|
|
Vibrant Soundbridge - P990052
|
Hearing Implant
|
08/31/00
|
|
Horizon 55 EW and Horizon 55 EW Westint Contact Lenses - P990072
|
Contact Lens
|
08/22/00
|
|
QUS-2 Calcaneal Ultrasonometer - P990039
|
Bone Ultrasound
|
08/08/00
|
|
Medtronic® IsoMed® Constant Flow Infusion System
|
Infusion Pump
|
07/21/00
|
|
Mentor Alpha I Inflatable Penile Prosthesis - P000006
|
Penile Implant
|
07/14/00
|
|
Mosaic Porcine Bioprosthesis, Model 305 (Aortic) and Model 310 (Mitral) - P990064
|
Heart Valve
|
07/14/00
|
|
Menicon Z™ (tisilfocon A) Rigid Gas Permeable Contact Lens - P990018
|
Contact Lens
|
07/11/00
|
|
Diomed 630 PDT Laser Model T2USA - P990021
|
Laser
|
06/30/00
|
|
Hyperion™ LTK System - P990078
|
Laser
|
06/30/00
|
|
Vascular Solutions Duett™ Sealing Device
|
Vascular Sealant
|
06/22/00
|
|
NAVI-STAR® Diagnostic/Ablation Deflectable Tip Catheter - P990025
|
Ablation Catheter
|
06/15/00
|
|
Medtronic Model 7250 Jewel® AF Implantable Cardioverter Defibrillator System - P980050
|
Defibrillator
|
06/14/00
|
|
CoStasis/DynaStat Surgical Hemostat - P990030
|
Vascular Sealant
|
06/13/00
|
|
Stockert 70 RF Generator - P990071
|
Ablation Device
|
05/31/00
|
|
FocalSeal-Synthetic Absorbable Sealant
|
Lung Sealants
|
05/26/00
|
|
OxiFirst Fetal Oxygen Saturation Monitoring System
|
Fetal Oxygen Monitor
|
05/12/00
|
