Berlin Heart EXCOR® Pediatric Ventricular Assist Device (VAD) - H100004
|
VAD
|
12/16/11
|
AtriCure Synergy Ablation System - P100046
|
Ablation Clamp
|
12/15/11
|
Elecsys® Anti-HBc IgM Immunoassay and Elecsys® PreciControl Anti-HBc IgM for use on the MODULAR ANALYTICS E170 Immunoassay Analyzer - P110025
|
HBV Test
|
12/14/11
|
HER2 CISH pharmDx™ Kit - P100024
|
Cancer Test
|
11/30/11
|
PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System - P110010
|
Stent
|
11/22/11
|
BSD-2000 Hyperthermia System - H090002
|
Cervical Cancer
|
11/18/11
|
Belotero Balance - P090016
|
Wrinkles
|
11/14/11
|
Edwards SAPIEN Transcatheter Heart Valve (THV) - P100041
|
Heart Valve
|
11/02/11
|
OVATION Abdominal Stent Graft System - H100008
|
Stent
|
11/01/11
|
MelaFind® - P090012
|
Imaging
|
11/01/11
|
XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System - P110019
|
Stent
|
11/01/11
|
APTIMA® HPV Assay - P100042
|
HPV Assay
|
10/28/11
|
Assurant® Cobalt Iliac Balloon-Expandable Stent System - P110011
|
Stent
|
10/26/11
|
Elecsys® Anti-HBc IgM Immunoassay and Elecsys® PreciControl Anti-HBc IgM on the cobas e 601 analyzer - P110022
|
Hepatitis B Virus (HBV)
|
10/26/11
|
Restylane® Injectable Gel - P040024/S051
|
Wrinkle Filler
|
10/11/11
|
EUFLEXXA® - P010029/S008
|
Osteoarthritis
|
10/11/11
|
ADVIA Centaur® HBeAg Assay and ADVIA Centaur® HBeAg Quality Control Material - P090024
|
HBeAg Test
|
10/11/11
|
NeuRx Diaphragm Pacing System™ - H100006
|
Diaphragm
|
09/28/11
|
LeGoo® - P110003
|
Surgical
|
09/28/11
|
Vysis ALK Break Apart FISH Probe Kit, with the Vysis Paraffin Pretreatment IV and Post Hybridization Wash Buffer Kit, ProbeChek ALK Negative Control Slides, and ProbeChek ALK Positive Control Slides - P110012
|
Genetic Test
|
08/26/11
|
cobas® 4800 BRAF V600 Mutation Test - P110020
|
Molecular Assay
|
08/17/11
|
Propel - P100044
|
Sinus Implant
|
08/11/11
|
RX Herculink Elite Renal Stent System - P110001
|
Renal Stent
|
07/20/11
|
VITROS® Immunodiagnostic Products Anti-HBe Reagent Pack, Calibrator and Controls - P100001
|
HBV test
|
07/20/11
|
Elecsys® Anti-HBc Immunoassay and Elecsys® PreciControl Anti-HBc on the Elecsys® 2010 Immunoassay Analyzer – P100032
|
HBV test
|
06/27/11
|
Elecsys® Anti-HBc Immunoassay and Elecsys® PreciControl Anti-HBc for use on the E170 MODULAR ANALYTICS - P100031
|
HBV test
|
06/22/11
|
INFORM HER2 Dual ISH DNA Probe Cocktail – P100027
|
DNA Probe Cocktail
|
06/14/11
|
Pinnacle® CoMplete® Acetabular Hip System - P090002
|
Hip Replacement
|
06/13/11
|
Solesta® - P100014
|
Fecal Incontinence
|
05/27/11
|
XIENCE nano™ Everolimus Eluting Coronary Stent System - P070015/S054
|
Stents
|
05/24/11
|
EXOSEAL Vascular Closure Device - P100013
|
Vascular Plug
|
05/19/11
|
Abbott RealTime HCV – P100017
|
Hepatitis C
|
05/17/11
|
VITROS® Immunodiagnostic Products HBeAg Reagent Pack, Calibrator and Controls - P090028
|
HBV test
|
05/11/11
|
RX Acculink Carotid Stent System - P040012/S034
|
Stents
|
05/06/11
|
AcrySof® Toric Intraocular Lens - (IOL) - P930014/S045
|
Intraocular Lens
|
05/03/11
|
ION™ Paclitaxel-Eluting Coronary Stent System - P100023
|
Stents
|
04/22/11
|
St. Jude Medical® Trifecta™ Valve – P100029
|
Heart Valve
|
04/20/11
|
cobas HPV Test – P100020
|
HPV test
|
04/19/11
|
NovoTTF-100A System - P100034
|
Tumor Treatment
|
04/08/11
|
Pipeline™ Embolization Device - P100018
|
Aneurysms
|
04/06/11
|
cPAX Aneurysm Treatment System - H100002
|
Aneurysms
|
04/01/11
|
Valiant® Thoracic Stent Graft with the Captiva Delivery System - P100040
|
Aneurysms
|
04/01/11
|
MEL 80™ Excimer Laser System - P060004/S001
|
LASIK
|
03/28/11
|
Gel-One® - P080020
|
Osteoarthritis
|
03/22/11
|
Medtronic® InterStim® Therapy System - P080025
|
Incontinence
|
03/14/11
|
Elana Surgical KitHUD - H080005
|
Neurosurgery
|
03/10/11
|
OraQuick HCV Rapid Antibody Test - P080027/S001
|
Hepatitis C
|
02/18/11
|
LAP-BAND® Adjustable Gastric Banding System - P000008/S017
|
Gastric Band
|
02/16/11
|
Selenia Dimensions 3D System - P080003
|
Mammography
|
02/11/11
|
Revo MRI SureScan Pacing System - P090013
|
Pacing
|
02/08/11
|
Formula Balloon-Expandable Renal Stent System - P100028
|
Stents
|
01/14/11
|