| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S085) | Cordis Corp. | 2012-01-26 |
| TELIGEN/INCEPTA/ENERGEN/PUNCTUA/CONFIENT ICDS (P960040/S250) | Boston Scientific | 2012-01-26 |
| COGNIS/INCEPTA/ENERGEN/PUNCTUA/LIVIAN CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (P010012/S278) | Boston Scientific Corp | 2012-01-26 |
| RESTYLANE INJECTABLE GEL (P040024/S053) | Q-Med AB | 2012-01-26 |
| COGNIS/INCEPTA/ENERGEN/PUNCTUA CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (P010012/S277) | Boston Scientific Corp | 2012-01-25 |
| TELIGEN/INCEPTA/ENERGEN/PUNCTUA ICDS (P960040/S249) | Boston Scientific | 2012-01-25 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S032) | Boston Scientific Corp | 2012-01-25 |
| THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR (P110016) | ABBOTT MEDICAL | 2012-01-25 |
| ADATO SIL-OL 5000 SILICONE OIL (P910071/S013) | Bausch & Lomb | 2012-01-24 |
| GENESYS HTA SYSTEM (P000040/S020) | Axora Medical, Inc. | 2012-01-24 |
| AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) NON-WOVEN WEB/ENDOAVITENE (P800002/S018) | C.R. Bard, Inc. | 2012-01-23 |
| REVIEW SCOPE MANUAL (P020002/S006) | Hologic, Inc. | 2012-01-23 |
| M-VU ALGORITHM ENGINE (P100005) | Icad, Inc. | 2012-01-23 |
| AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FAMILY/FLOUR/SYRINGEAVITENE/CAST MICROFIBRILLAR COLLAGEN HEMOSTAT(MCH) (N17600/S026) | Davol Inc., Sub. C. R. Bard, Inc. | 2012-01-23 |
| PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (P890047/S035) | Alcon Research, Ltd. | 2012-01-20 |
| INTERSTIM II NEUROSTIMULATOR (P080025/S025) | Medtronic Neuromodulation | 2012-01-20 |
| MEDTRONIC INTRATHECAL CATHETERS (P860004/S147) | Medtronic, Inc. | 2012-01-20 |
| JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S018) | Allergan | 2012-01-20 |
| INTREL 3 IMPLANTABLE NEUROSTIMULATORS/SYNERGY/RESTORE FAMILIES OF IMPLANTABLE NEUROSTIMULATORS (P840001/S203) | Medtronic Neuromodulation | 2012-01-20 |
| SOLETRA/KINETRA NEUROSTIMULATORS/ACTIVA FAMILY OF NEUROSTIMULATORS (P960009/S136) | Medtronic, Inc. | 2012-01-20 |
| ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY AND QAULITY CONTROL MATERIAL (P100039) | Siemens Healthcare Diagnostics, Inc. | 2012-01-20 |
| ISPAN SULFUR HEXAFLUORIDE SF6 GAS (P900067/S007) | Airgas Therapeutics, LLC | 2012-01-20 |
| XIENCE V & XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S085) | Abbott Vascular, Inc. | 2012-01-20 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S031) | Boston Scientific Corp | 2012-01-20 |
| INTERSTIM NEUROSTIMULATOR (P970004/S128) | Medtronic Neuromodulation | 2012-01-20 |
| ALERE NMP22 URINE COLLECTION KIT (P940035/S007) | Abbott Diagnostics Scarborough, Inc. | 2012-01-20 |
| CERVISTA HUMAN PAPILLOMA VIRUS (HPV) HIGH RISK (HR) (P080014/S010) | Hologic, Inc. | 2012-01-20 |
| REFLECTION CERAMIC HIP SYSTEM (RCHS) (P030022/S020) | Smith & Nephew, Inc. | 2012-01-20 |
| VISCOAT/DUOVISC/DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICES (P840064/S047) | Alcon Laboratories | 2012-01-20 |
| EBI OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATOR (P790005/S048) | Ahp Eos Buyer, Inc. | 2012-01-20 |
| XIENCE PRIME & XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P110019/S008) | Abbott Vascular | 2012-01-20 |
| JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S020) | Allergan | 2012-01-20 |
| BIOLOGICAL INDICATOR (BI) (P080004/S010) | Hoya Surgical Optics, Inc. | 2012-01-20 |
| TELIGEN/INCEPTA/ENERGEN/PUNCTUA IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P960040/S248) | Boston Scientific | 2012-01-19 |
| COGNIS/INCEPTA/ENERGEN/PUNCTUA CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (P010012/S276) | Boston Scientific Corp | 2012-01-19 |
| GENESIS/EON/EON C/EON NEUROSTIMULATION SYSTEMS (P010032/S045) | ABBOTT MEDICAL | 2012-01-19 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S003) | Edwards Lifesciences, LLC | 2012-01-19 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSUR MITRAL BIOPROSTHESIS (P870077/S041) | Edwards Lifesciences, LLC | 2012-01-19 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S028) | Edwards Lifesciences, LLC | 2012-01-19 |
| CARPENTIER-EDWARDS BIOPROSTHESES (P870056/S045) | Edwards Lifesciences, LLC | 2012-01-19 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES (P860057/S082) | Edwards Lifesciences, LLC | 2012-01-19 |
| CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS (P010041/S029) | Edwards Lifesciences, LLC | 2012-01-19 |
| REVO MRI (P090013/S049) | Medtronic, Inc. | 2012-01-18 |
| DEMA IPG/C & T SERIES IPGS (P990001/S099) | Medtronic, Inc. | 2012-01-18 |
| KAPPA 700/800/900/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENSIA/RELIA/ADVISA DR IPGS (P980035/S255) | Medtronic, Inc. | 2012-01-18 |
| PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM (P060001/S016) | Medtronic Vascular, Inc. | 2012-01-18 |
| XIENCE PRIME/XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S006) | Abbott Vascular | 2012-01-18 |
| BARD FLAIR ENDOVASCULAR STENT GRAFT (P060002/S023) | Bard Peripheral Vascular | 2012-01-18 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S004) | Edwards Lifesciences, LLC | 2012-01-18 |
| INSYNC/INSYNC III/CONSULTA/SYNERA CRT-PS (P010015/S151) | Medtronic, Inc. | 2012-01-18 |
| KAPPA 400 DR/SR IPG (P970012/S090) | Medtronic, Inc. | 2012-01-18 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES (P860057/S083) | Edwards Lifesciences, LLC | 2012-01-18 |
| VNS THERAPY SYSTEM (P970003/S143) | LivaNova USA, Inc. | 2012-01-18 |
| DEXCOM SEVEN & SEVEN PLUS SYSTEM (P050012/S043) | Dexcom, Inc. | 2012-01-18 |
| TRIDENT SYSTEMS (P000013/S010) | Howmedica Osteonics Corp. | 2012-01-18 |
| MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II/VIRTUOSO II/SECURA/PROTECTA XT/PROTECTA/PROTECTA XT/PROTECTA DF4 ICD (P980016/S333) | Medtronic Cardiac Rhythm Disease Management | 2012-01-18 |
| PRODOGY (P890003/S243) | Medtronic, Inc. | 2012-01-18 |
| XIENCE PRME & XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P110019/S007) | Abbott Vascular | 2012-01-18 |
| INSYNC/INSYNC II/III MARQUIS/INSYNC SENTRY/MAXIMO ICDS/CONCERTO/II/MAXIMO II/CONSULTA/PROTECTA XT/PROTECTA/PROTECTA DF4 (P010031/S286) | Medtronic Cardiac Rhythm Disease Management | 2012-01-18 |
| CODMAN 3000 SERIES CONSTANT FLOW IMPLANTABLE INFUSION PUMP AND ACESSORIES (P890055/S038) | Intera Oncology | 2012-01-17 |
| STAARVISC II & SHELLGEL SODIUM HYALURONATE (P000046/S017) | Anika Therapeutics, Inc. | 2012-01-17 |
| AMVISC & AMVISC PLUS (OPHTHALMIC VISCOSURGICAL DEVICES) (P810025/S029) | Bausch & Lomb, Inc. | 2012-01-17 |
| COGNIS/INCEPTA/ENERGEN/PUNCTUA CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATORS (P010012/S275) | Boston Scientific Corp | 2012-01-13 |
| SPECTRANETICS LASER SHEATHS (SLS) (P960042/S029) | Spectranetics (Philips) | 2012-01-13 |
| FREEZOR CARDIAC CRYOABLATION CATHETER/FREEZOR XTRA & MAX SURGICAL CARDIAC CRYOABLATION DEVICE (P020045/S041) | Medtronic Cryocath, LP | 2012-01-13 |
| PROMUS ELEMENT PLUS PLATINUM CHROMIUM EVEROLIMUS-ELUTING CORONARY STENT SYSTEM (P110010/S003) | Boston Scientific Corp | 2012-01-13 |
| GORE EXCLUDER AAA ENDOPROSTHESIS CATHETER (P020004/S068) | W. L. Gore & Associates, Inc. | 2012-01-13 |
| TELIGEN/INCEPTA/ENERGEN/PUNCTUA IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P960040/S247) | Boston Scientific | 2012-01-13 |
| FREEZOR MAX CARDIAC CRYOABLATION CATHETER (P100010/S013) | Medtronic Cryocath, LP | 2012-01-13 |
| INTERSTIM LEADS (P080025/S024) | Medtronic Neuromodulation | 2012-01-13 |
| INTERSTIM LEADS (P970004/S127) | Medtronic Neuromodulation | 2012-01-13 |
| ABBOTT ARCHITECT HBSAG & HBSAG CONFIRMATORY (P060007/S017) | Abbott Laboratories | 2012-01-13 |
| SYNCHROMED II INFUSION PUMP (P860004/S151) | Medtronic, Inc. | 2012-01-13 |
| NAVISTAR RMT THERMOCOOL CATHETER (P040036/S024) | Biosense Webster, Inc. | 2012-01-13 |
| SPINAL CORD STIMULATIONS LEADS (SCS) (P840001/S202) | Medtronic Neuromodulation | 2012-01-13 |
| NAVISTAR RMT THERMOCOOL CATHETER (P030031/S033) | Biosense Webster, Inc. | 2012-01-13 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S047) | Spectranetics Corp. | 2012-01-13 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S040) | W. L. Gore & Associates, Inc. | 2012-01-13 |
| DEEP BRAIN STIMULATION (DBS) LEADS (P960009/S135) | Medtronic, Inc. | 2012-01-13 |
| HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P.) FUTURA APHERESIS SYSTEM (P940016/S014) | B. Braun Avitum AG | 2012-01-13 |
| MYNXGRIP VASCULAR CLOSURE DEVICE (6F/7F) (P040044/S040) | Cordis US Corporation | 2012-01-13 |
| RESTORESENSOR IMPLANTABLE NEUROSTIMULATOR (P840001/S201) | Medtronic Neuromodulation | 2012-01-12 |
| COBAS AMPLICOR HCV TEST V2.0, COBAS AMPLIPREP/ COBAS AMPLICOR HCV TEST, V2.0 (P000012/S033) | Roche Molecular Systems, Inc. | 2012-01-11 |
| AMPLICOR HCV TEST (P000010/S024) | Roche Molecular Systems, Inc. | 2012-01-11 |
| PARADYM VR/DR (P980049/S068) | MicroPort CRM USA, Inc. | 2012-01-11 |
| PARADYM CRT (P060027/S035) | MicroPort CRM USA, Inc. | 2012-01-11 |
| ARTEGRAFT COLLAGEN VASCULAR GRAFT (N16837/S008) | LeMaitre Vascular, Inc. | 2012-01-10 |
| AMPLATZER SEPTAL OCCLUDER (P000039/S043) | ABBOTT MEDICAL | 2012-01-10 |
| THERAKOS CELLEX PHOTOPHERESIS SYSTEM (P860003/S063) | Therakos Development Limited | 2012-01-10 |
| O2OPTIX/AIR OPTIX AQUA/AIR OPTIX FOR ASTIGMATISM/AIR OPTIX AQUA MULTIFOCAL (P010019/S027) | Alcon Laboratories, Inc. | 2012-01-10 |
| MEDTRONIC CONSULTA CRT-D D204TRM, MAXIMO II CRT-D D264TRM IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P010031/S176) | Medtronic Cardiac Rhythm Disease Management | 2012-01-09 |
| MEDTRONIC SPRINT QUATTRO SECURE LEAD MODEL 6947M (P920015/S055) | Medtronic, Inc. | 2012-01-09 |
| CARELINK HOME MONITOR MODEL 2490C, CARDIOSIGHT READER MODEL 2020A, CAELINK NETWORK DEVICE (P890003/S179) | Medtronic, Inc. | 2012-01-09 |
| MEDTRONIC SECURA DR D204DRM, MAXIMO II D264DRM, IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P980016/S216) | Medtronic Cardiac Rhythm Disease Management | 2012-01-09 |
| MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY (P040044/S042) | Cordis US Corporation | 2012-01-06 |
| EON NEUROSTIMULATION SYSTEMS (P010032/S044) | ABBOTT MEDICAL | 2012-01-06 |
| VISION/MINIVISION & ML8 CORONARY STENT SYSTEMS (P020047/S036) | Abbott Vascular | 2012-01-06 |
| LCS TOTAL KNEE SYSTEM (P830055/S119) | Depuy, Inc. | 2012-01-06 |
| MULTILINK ZETA/PIXEL & ULTRA CORONARY STENT SYSTEMS (P970020/S065) | Abbott Vascular, Inc. | 2012-01-06 |
| ENDURANT STENT GRAFT SYSTEM (P100021/S012) | Medtronic Vascular | 2012-01-06 |