|
ADVIA Centaur® HBc Total ReadyPack Reagents, ADVIA Centaur® HBc Total Quality Control Materials - P040004
|
Hepatitis Test
|
12/27/04
|
|
Roche AmpliChip Cytochrome P450 Genotyping test and Affymetrix GeneChip Microarray Instrumentation System - K042259
|
Genetic Test
|
12/23/04
|
|
ADVIA Centaur® HAV IgM - P040018
|
Hepatitis Test
|
12/22/04
|
|
Bayer ADVIA® Centaur™ HCV Assay - P030056
|
Hepatitis Test
|
12/22/04
|
|
InSite™ Her-2/neu kit - P040030
|
Breast Cancer Test
|
12/22/04
|
|
Reflection® Ceramic Acetabular System
|
Hip Prostheses
|
12/17/04
|
|
GORE VIATORR® TIPS Endoprosthesis - P040027
|
Stent
|
12/06/04
|
|
URYX® Urethral Bulking Agent - P030030
|
Urinary Bulking Agent
|
12/16/04
|
|
Vysis® AutoVysion™ System - K041875
|
Genetic Test
|
12/13/04
|
|
Nuflexxa™ (1 percent Sodium Hyaluronate) - P010029
|
Arthritis Injection
|
12/03/04
|
|
Kodak Mammography CAD ENGINE - P030007
|
Mammography
|
11/23/04
|
|
NAVISTAR™ and CELSIUS™ THERMOCOOL® Irrigated Deflectable Diagnostic/Ablation Catheter - P030031
|
Ablation Catheter
|
11/05/04
|
|
Hamilton Thorne Zona Infrared Laser Optical System (ZILOS-tk®) - K040045
|
Laser
|
11/04/04
|
|
EVS™ Vascular Closure System - P040022
|
Vascular Closure Device
|
11/03/04
|
|
Endologix PowerLink® System - P040002
|
Vascular Graft
|
10/29/04
|
|
CHARITÉ™ Artificial Disc - P040006
|
Spinal Disc
|
10/26/04
|
|
ExAblate® 2000 System - P040003
|
Fibroid Treatment
|
10/22/04
|
|
Syncardia Temporary CardioWest Total Artificial Heart (TAH-t) - P030011
|
Artificial Heart
|
10/15/04
|
|
JSZ Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear - P040029
|
Contact Lens
|
09/29/04
|
|
Philips HeartStart Home OTC Defibrillator - K040904
|
Defibrillator
|
09/16/04
|
|
Guidant Cardiac Resynchronization Therapy Defibrillators (COMPANION trial) - P010012/S026
|
Defibrillator
|
09/14/04
|
|
ADVIA Centaur® Anti-HBs ReadyPack Reagents and Calibrators - P030029
|
Hepatitis Test
|
09/10/04
|
|
Verisyse™ Phakic IOL - P030028
|
Intraocular Lens (IOL)
|
09/10/04
|
|
ACCULINK™ Carotid Stent System / RX ACCULINK™ Carotid Stent System - P040012
|
Stent
|
08/30/04
|
|
NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit, Model MS-8970 - K031878
|
Amino Acid Test
|
08/24/04
|
|
Vertical Expandable Prosthetic Titanium Rib (VEPTR) - H030009
|
Prostheses
|
08/23/04
|
|
Siemens Mammomat Novation DR Full Field Digital Mammography System - PMA P030010
|
Mammography
|
08/20/04
|
|
Ventana® Medical Systems' PATHWAY Anti-c-KIT (9.7) Primary Antibody
|
Rib Prosthesis
|
08/11/04
|
|
ADVIA Centaur® HBc IgM ReadyPack Reagents / ADVIA Centaur® HBc IgM Quality Control (Calibrator and Control) Materials - P030040
|
Hepatitis Test
|
08/06/04
|
|
Sculptra - P030050
|
Wrinkle Filler
|
08/03/04
|
|
CEDIA® Sirolimus Assay - K034069
|
Lab Test
|
07/28/04
|
|
INTACS® Prescription Inserts for Keratoconus - H040002
|
Corneal Insert
|
07/26/04
|
|
Stelid II, Stelix, and Stelix II steroid eluting endocardial pacing leads - P020030
|
Pacemaker
|
07/17/04
|
|
bioMerieux VIDAS total PSA assay - P040008
|
PSA Test
|
07/08/04
|
|
St. Jude Medical® Epic™ HF and Atlas® + HF Dual Chamber Implantable Cardioverter Defibrillator Systems with Cardiac Resynchronization Therapy - P030054
|
Defibrillators
|
06/30/04
|
|
IntraStent® DoubleStrut™ Stent- P030045
|
Stent
|
06/08/04
|
|
Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear - P010062
|
Contact Lens
|
06/07/04
|
|
Glucatell™ - K032373
|
Lab Test
|
05/21/04
|
|
St. Jude Medical Frontier™ Biventricular Cardiac Pacing System
|
Pacemaker
|
05/13/04
|
|
INFUSE® Bone Graft - P000054
|
Bone Graft
|
04/30/04
|
|
Oculaid™ Capsular Tension Ring, or Stableyes™ Capsular Tension Ring - P030023
|
Intraocular Lens (IOL)
|
04/27/04
|
|
PRECISION™ Spinal Cord Stimulator (SCS) System - P030017
|
Spinal Stimulator
|
04/27/04
|
|
Hylaform - P030032
|
Wrinkle Filler
|
04/22/04
|
|
Oxford™ Meniscal Unicompartmental Knee System - P010014
|
Knee Prosthesis
|
04/21/04
|
|
OP-1 Putty - H020008
|
Spinal Implant
|
04/07/04
|
|
TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System - P030025
|
Stent
|
03/04/04
|
|
Vitros Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Vitros Immunodiagnostic Products Anti-HBc IgM Calibrator - P030026
|
Hepatitis Test
|
04/03/04
|
|
Vitros Immunodiagnostic Products Anti-HBc Reagent Pack and Vitros Immunodiagnostic Products Anti-HBc Calibrator - P030024
|
Hepatitis Test
|
03/04/04
|
|
DeBakey VAD® Child - H030003
|
Ventricular Assist Device
|
02/25/04
|
|
Heartsbreath - H030004
|
Lab Test
|
02/24/04
|
|
Prolieve™ - P030006
|
Prostate Treatment
|
02/19/04
|
|
DakoCytomation EGFR pharmDx™ - P030044
|
Lab Test
|
02/12/04
|
|
Abbott AxSYM® Antibody to Hepatitis C Virus - P970027
|
Hepatitis Test
|
02/05/04
|
|
AxSYM Free PSA - P980007
|
PSA Test
|
02/05/04
|
|
Orthovisc® High Molecular Weight Hyaluronan - P030019
|
Arthritis Injection
|
02/04/04
|
|
CONTAK® RENEWAL™ TR Models H120 and H125 - P030005
|
Pacemaker
|
01/26/04
|
|
CellSearch™ Epithelial Cell Kit / CellSpotter™ Analyzer - K031588
|
Breast Cancer Test
|
01/21/04
|
