| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S425) | Medtronic Cardiac Rhythm Disease Management | 2014-03-20 |
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S085) | St. Jude Medical, Inc. | 2014-03-20 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S463) | Medtronic Cardiac Rhythm Disease Management | 2014-03-20 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S055) | Boston Scientific Corp | 2014-03-19 |
| ARISTA AH ABSORBABLE HEMOSTAT (P050038/S021) | Davol, Inc. | 2014-03-19 |
| RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM (P110013/S036) | Medtronic Vascular | 2014-03-19 |
| EXPRESS 2 MONORAIL AND OTW CORONARY STENT SYSTEM (P020009/S117) | Boston Scientific Scimed, Inc. | 2014-03-19 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S089) | Medtronic, Inc. | 2014-03-19 |
| RESTOREPRIME NEUROSTIMULATOR,PRIMEADVANCED NEUROSTIMULATOR,ITREL 4 NEUROSTIMULATOR,PRIMEADVANCED SURESCAN MRI NEUROSTIMU (P840001/S262) | Medtronic Neuromodulation | 2014-03-19 |
| INTEGRITY CORONARY STENT SYSTEMS (P030009/S075) | Medtronic, Ireland | 2014-03-19 |
| ARCTIC FRONT AND ARCTIC FRONT ADVANCE CRYOABLATION CATHETERS (P100010/S031) | Medtronic Cryocath, LP | 2014-03-19 |
| ACTIVA PC NEUROSTIMULATOR,ACTIVA SCNEUROSTIMULATOR,ACTIVA SC NEUROSTIMULATOR (P960009/S189) | Medtronic, Inc. | 2014-03-19 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S123) | Boston Scientific Scimed, Inc. | 2014-03-19 |
| MONOLISA ANTI-HBC IGM EIA (P060034/S008) | Bio-Rad Laboratories, Inc. | 2014-03-19 |
| INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE (P900033/S032) | Integra Lifesciences Corp. | 2014-03-18 |
| PARADYM ICD (P980049/S090) | MicroPort CRM USA, Inc. | 2014-03-18 |
| HELISTAT HELITENSE ABSORBABLE COLLLAGENHEMOSTATIC AGENT MICROFIBRILLAR FORM (P850010/S046) | Integra LifeSciences Corporation | 2014-03-18 |
| COMBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0 (P050028/S040) | Roche Molecular Systems, Inc. | 2014-03-18 |
| THORATEC VENTRICULAR ASSIST DEVICE (P870072/S059) | Thoratec Laboratories Corp. | 2014-03-18 |
| MEMORY GEL SILICONE GEL- FILLED BREAST IMPLANTS (P030053/S016) | Mentor Corp. | 2014-03-18 |
| REPLY/ESPRIT PACEMAKERS (P950029/S086) | MicroPort CRM USA, Inc. | 2014-03-18 |
| COBAS AMPLIPREP/COMBAS TAQMAN HCV TEST V2.0 (P060030/S040) | Roche Molecular Systems, Inc. | 2014-03-18 |
| COLLASTAR INSTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT MICROFIBRILLAR (P810006/S048) | Integra LifeSciences Corporation | 2014-03-18 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (P030011/S023) | Syncardia Systems, LLC | 2014-03-18 |
| COLLACOTE, COLLA TAPE, COLLA PLUG ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY (P840062/S035) | Integra Lifesciences Corp. | 2014-03-18 |
| ON-X PROSTHETIC HEART VALVE (P000037/S035) | On-X Life Technologies, Inc. | 2014-03-18 |
| COBAS AMPLIPREP/COBAS TAQMAN CMV TEST (P110037/S013) | Roche Molecular Systems, Inc. | 2014-03-18 |
| THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM DEVICE (LVAS) (P060040/S032) | ABBOTT MEDICAL | 2014-03-18 |
| GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM (P970021/S040) | Gynecare, Inc. | 2014-03-17 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S088) | Boston Scientific Corp | 2014-03-14 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIO (P860057/S119) | Edwards Lifesciences, LLC | 2014-03-14 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S039) | Medtronic | 2014-03-14 |
| CARPENTIER-EDWARDS PORCINE AORTIC AND MITRAL BIOPROSTHESIS (P870056/S065) | Edwards Lifesciences, LLC | 2014-03-14 |
| COAPTITE INJECTABLE IMPLANT (P040047/S034) | Merz North America, Inc. | 2014-03-14 |
| ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG (P130015) | Roche Diagnostics Operations, Inc. | 2014-03-14 |
| CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS (P010041/S048) | Edwards Lifesciences, LLC | 2014-03-14 |
| PROMUS ELEMENT PLUS / PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S076) | Boston Scientific Corp | 2014-03-14 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S035) | Medtronic Vascular | 2014-03-14 |
| DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS, DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE (P870077/S059) | Edwards Lifesciences, LLC | 2014-03-14 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S037) | Medtronic | 2014-03-13 |
| MINIMED 530G INSULIN PUMP (P120010/S008) | Medtronic, Inc. | 2014-03-13 |
| PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP, (P980022/S150) | Medtronic Minimed | 2014-03-13 |
| PROMUS ELEMENT PLUS / PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S075) | Boston Scientific Corp | 2014-03-13 |
| RF CONDUCTR MC,RF CONTACTR,RF ENHANCR II,RF MARINR (P930029/S041) | Medtronic, Inc. | 2014-03-13 |
| HVAD SEWING RING-HEARTWARE VENTRICULAR ASSIST SYTEM (P100047/S038) | Medtronic | 2014-03-13 |
| RADIESSE DERMAL FILLER (P050037/S047) | Merz North America, Inc. | 2014-03-13 |
| MEDTRONIC SPINAL CORD STIMULATION SYSTEMS (P840001/S261) | Medtronic Neuromodulation | 2014-03-13 |
| RADIESSE DERMAL FILLER (P050052/S051) | Merz North America, Inc. | 2014-03-13 |
| Y ADAPTOR/EXTENDER KIT, DF-1 CONNECTOR PORT PIN PLUG, HV SPLITTER/ADAPTOR KIT, IS-1 CONNECTOR PORT PIN PLUG KIT, LEAD (P920015/S131) | Medtronic, Inc. | 2014-03-12 |
| COBAS EGFR MUTATION TEST (P120019/S004) | Roche | 2014-03-12 |
| LIVEWIRE TC CARDIAC ABLATION SYSTEM (P960016/S043) | St Jude Medical | 2014-03-12 |
| ADHESIVE, CAPSURE SENSE LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD, VITATRON EXCELLENCE PS+ LEAD (P830061/S108) | Medtronic Cardiac Rhythm Disease Management | 2014-03-12 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG (P980035/S367) | Medtronic, Inc. | 2014-03-12 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S059) | Medtronic, Inc. | 2014-03-12 |
| BATTERY CHECK MONITOR, CAPSURE LEAD, CARELINK PROGRAMMER, CARELINK PROGRAMMER RF HEAD, DESKTOP BOSS SOFTWARE, ECG CABLE (P890003/S303) | Medtronic, Inc. | 2014-03-12 |
| PUNCTUA ICD, TELIGEN, ENERGEN ICD, INCEPTA ICD (P960040/S309) | Boston Scientific | 2014-03-12 |
| EGMP5 DOWNLOAD SOFTWARE APPLICATION,EVERA S DR ICD.EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,MAXIMO II ICD,PATIENT (P980016/S469) | Medtronic Cardiac Rhythm Disease Management | 2014-03-12 |
| ATTAIN BIPOLAR OTW LEAD,CONSULTA CRT-P,LEFT VENTRICULAR PACING LEAD,SYNCRA CRT-P (P010015/S234) | Medtronic, Inc. | 2014-03-12 |
| ANCHORING SLEEVE KIT ; SELECT SECURE LEAD (P030036/S071) | Medtronic Cardiac Rhythm Disease Management | 2014-03-12 |
| CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD, CAPSURE Z NOVUS LEAD, VITATRON IMPULSE II LEAD (P850089/S107) | Medtronic Cardiac Rhythm Disease Management | 2014-03-12 |
| VITA ENHANCR II (P990001/S117) | Medtronic, Inc. | 2014-03-12 |
| EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD (P980016/S467) | Medtronic Cardiac Rhythm Disease Management | 2014-03-12 |
| CAPSUREFIX MRI LEAD,REVO MRI IPG (P090013/S133) | Medtronic, Inc. | 2014-03-12 |
| PUNCTUA CRT-D, COGNIS, ENERGEN CRT-D, INCEPTA CRT-D (P010012/S346) | Boston Scientific Corp | 2014-03-12 |
| COBAS BRAF V600 MUTATION TEST (P110020/S010) | Roche Molecular Systems, Inc. | 2014-03-12 |
| ARISTA AH ABSORBABLE HEMOSTAT (P050038/S020) | Davol, Inc. | 2014-03-12 |
| DISPOSABLE EPG COVER (P820003/S128) | Medtronic Cardiac Rhythm Disease Management | 2014-03-12 |
| BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, XT CRT-D, VIVA S CRT-D, XTCRT-D (P010031/S430) | Medtronic Cardiac Rhythm Disease Management | 2014-03-12 |
| ATTAIN STARFIX LEAD (P060039/S057) | Medtronic, Inc. | 2014-03-12 |
| RF CONTACTR CATHETER, RF ENHANCR II CATHETER, RF MARINR CATHETER, RF CONDUCTR CATHETER (P930029/S042) | Medtronic, Inc. | 2014-03-12 |
| S-ICD SYSTEM (P110042/S027) | Boston Scientific Corporation | 2014-03-12 |
| TRANSVENE CS/SVC LEAD (P980050/S091) | Medtronic, Inc. | 2014-03-12 |
| BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-D (P010031/S429) | Medtronic Cardiac Rhythm Disease Management | 2014-03-12 |
| ACE HEADER, CABLE, DEFIBRILLATION SUPPORT DEVICE (DISD), END CAP, EPICARDIAL PATCH LEAD, PATIENT MAGNET, UPSIZING SLEEVE (P900061/S128) | Medtronic Cardiac Rhythm Disease Management | 2014-03-12 |
| ATTAIN ABILITY LEAD (P080006/S067) | Medtronic, Inc. | 2014-03-12 |
| CAPSUREFIC LEAD, CAPSUREFIX NOVUS LEAD, SUREFIX LEAD, TORQUE CLIP DEVICE-ACCESSORY FODR 5076 LEAD, VITATRON CRYSTALLINE (P930039/S105) | Medtronic, Inc. | 2014-03-12 |
| LUMAX 6/7 AND ILESTO/IFORIA ICD/CRT D FAMILIES (P050023/S075) | Biotronik, Inc. | 2014-03-11 |
| DURASEAL DURAL SEALANT SYSTEM (P040034/S023) | Integra LifeSciences Corporation | 2014-03-11 |
| APLIGRAF (P950032/S070) | Organogenesis, Inc. | 2014-03-10 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S064) | Abbott Vascular | 2014-03-10 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S035) | Edwards Lifesciences, LLC | 2014-03-10 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS (P040037/S061) | W. L. Gore & Associates, Inc. | 2014-03-10 |
| ANTI-HBS QUANTITATIVE REAGENT PACK AND CALIBRATORS (P000014/S027) | Ortho-Clinical Diagnostics, Inc. | 2014-03-10 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S048) | Edwards Lifesciences, LLC | 2014-03-10 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S120) | Abbott Vascular, Inc. | 2014-03-10 |
| PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS)SYSTEMS (P030017/S190) | Boston Scientific Corp | 2014-03-07 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S465) | Medtronic Cardiac Rhythm Disease Management | 2014-03-07 |
| RADIESSE DERMAL FILLER (P050052/S045) | Merz North America, Inc. | 2014-03-07 |
| NUVASIVE PCM CERVICAL DISC SYSTEM (P100012/S005) | Nuvasive, Inc. | 2014-03-07 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S427) | Medtronic Cardiac Rhythm Disease Management | 2014-03-07 |
| PRECISION SPECTRA SYSTEM (P030017/S185) | Boston Scientific Corp | 2014-03-07 |
| RADIESSE DERMAL FILLER (P050037/S042) | Merz North America, Inc. | 2014-03-07 |
| AMS 700 SERIES INFATABLE PENILE PROSTHESIS (N970012/S097) | Boston Scientific Corp | 2014-03-06 |
| PARADYM RF:MODELS VR 9250, DR 9550, CRT-D 9750; PARADYM MODELS VR 8250, DR 8550, CRT-D 8750 (P060027/S053) | MicroPort CRM USA, Inc. | 2014-03-06 |
| BIRMINGHAM HIP RESURFACING SYSTEM (P040033/S023) | Smith & Nephew, Inc. | 2014-03-06 |
| SMARTVIEW REMOTE MONITORING SYSTEM: SMARTVIEW MONITOR PSTN MODEL, GPRS MODEL (P980049/S085) | MicroPort CRM USA, Inc. | 2014-03-06 |
| VIDAS TOTAL PSA (TPSA) ASSAY (P040008/S008) | bioMerieux, Inc. | 2014-03-06 |
| CURRENT, CURRENT ACCEL, CURRENT+, ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES (P910023/S332) | ABBOTT MEDICAL | 2014-03-06 |
| ASCENSION MCP (P000057/S007) | Smith & Nephew, Inc. | 2014-03-06 |
| PROMOTE, PROMOTE ACCEL, PROMOTE Q, PROMOTE QUADRA, PROMOTE+, QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUANDRA FAMILIES (P030054/S263) | ABBOTT MEDICAL | 2014-03-06 |