| DURASEAL DURAL SEALANT SYSTEM (P040034/S020) | Integra LifeSciences Corporation | 2011-12-16 |
| MED-EL COCHLEAR IMPLANT SYSTEMS (P000025/S059) | Med-El Corp. | 2011-12-16 |
| DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE (P000021/S021) | Siemens Healthcare Diagnostics | 2011-12-15 |
| DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE (P020027/S016) | Siemens Healthcare Diagnostics | 2011-12-15 |
| VISTAKON (ETAFILCON A) BRAND CONTACT LENSES (N18033/S063) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2011-12-15 |
| VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S030) | Vistakon, Division of Johnson & Johnson Vision Car | 2011-12-15 |
| ION (TAXUS ELEMENT) PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL) & OTW (P100023/S003) | Boston Scientific Corp | 2011-12-15 |
| INTRATHECAL CATHETER AND REVISION KITS (P860004/S136) | Medtronic, Inc. | 2011-12-15 |
| ELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICONTROL ANTI-HBC IGM FOR USE ON THE MODULAR ANAYTICS E170 IMMUNOASSAY ANA (P110025) | Roche Diagnostics Corp. | 2011-12-14 |
| ELECSYS ANTI-HCV IMMUNOASSAY COBAS E 601 (P090008/S007) | Roche Diagnostics Corp. | 2011-12-14 |
| PROMUS ELEMENT PLUS PLATINUM CHROMIUM EVEROLIMUS-ELUTING CORONARY STENT SYSTEM (P110010/S002) | Boston Scientific Corp | 2011-12-14 |
| AMS UROLUME ENDOPROSTHESIS (P920023/S030) | Boston Scientific Corp | 2011-12-14 |
| ATRICURE SYNERGY ABLATION SYSTEM (P100046) | AtriCure, Inc. | 2011-12-14 |
| PROTECTA & PROTECTA XT (P010031/S283) | Medtronic Cardiac Rhythm Disease Management | 2011-12-14 |
| PROTECTA AND PROTECTA XT (P980016/S330) | Medtronic Cardiac Rhythm Disease Management | 2011-12-14 |
| ION PLATINUM CHROMIUM PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S029) | Boston Scientific Corp | 2011-12-14 |
| ELECSYS ANTI-HCV IMMUNOASSAY ON MUDULAR ANALYTICS (P090009/S006) | Roche Diagnostics Corp. | 2011-12-14 |
| OPHTEC CAPSULAR TENSION RING MODELS 276 AND 275 AND STABILEYES MODELS STBL2US AND STBL13US (P030023/S001) | Ophtec BV | 2011-12-14 |
| ELECSYS ANTI-HCV INMMUNOASSAY ON COBAS E 411 (P090007/S006) | Roche Diagnostics Corp. | 2011-12-14 |
| ESTEEM (P090018/S017) | Envoy Medical Corporation | 2011-12-14 |
| ZENITH FLEX AAA ENDOVASCULAR GRAFT (P020018/S041) | Cook, Inc. | 2011-12-14 |
| GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER (P880047/S018) | ETHICON, Inc. | 2011-12-14 |
| 3F AORTIC BIOPROSTHESIS (P060025/S008) | Medtronic, Inc. | 2011-12-13 |
| MAXIMO II/PROTECTA/PROTECTA XT/SECURA/VIRTUOSO II (P980016/S328) | Medtronic Cardiac Rhythm Disease Management | 2011-12-13 |
| CONCERTO II/CONSULTA/MAXIMO II/PROTECTA/PROTECTA XT (P010031/S281) | Medtronic Cardiac Rhythm Disease Management | 2011-12-13 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S023) | Boston Scientific Corp | 2011-12-13 |
| ADAPTA/ADVISA/ENRHYTHM/RELIA/SENSIA/VERSA (P980035/S250) | Medtronic, Inc. | 2011-12-13 |
| REVO MRI (P090013/S045) | Medtronic, Inc. | 2011-12-13 |
| CONSULTA CRT-P & SYNCRA CRT-P (P010015/S146) | Medtronic, Inc. | 2011-12-13 |
| RX ACCULINK CARTOID STENT SYSTEM (P040012/S043) | Abbott Vascular | 2011-12-13 |
| PARADYM VR & DR (P980049/S067) | MicroPort CRM USA, Inc. | 2011-12-12 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS (P870077/S040) | Edwards Lifesciences, LLC | 2011-12-12 |
| CERVISTA HPV HR HIGH-THROUGHPUT AUTOMATION (P080014/S007) | Hologic, Inc. | 2011-12-12 |
| EDWARDS PRIMA PLUS PROCINE STENTLESS BIOPROSTHESTIC VALVES (P010041/S028) | Edwards Lifesciences, LLC | 2011-12-12 |
| DEEP BRAIN STIMULATION (DBS) (P960009/S132) | Medtronic, Inc. | 2011-12-12 |
| PARADYM CRT (P060027/S034) | MicroPort CRM USA, Inc. | 2011-12-12 |
| EDWARDS PORCINE STENTLESS BIOPROSTHETIC VALVES (P000007/S027) | Edwards Lifesciences, LLC | 2011-12-12 |
| SPINAL CORD STIMULATION (SCS) (P840001/S198) | Medtronic Neuromodulation | 2011-12-12 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHETIV VALVES (P860057/S081) | Edwards Lifesciences, LLC | 2011-12-12 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE (P060038/S010) | Corcym Canada Corp | 2011-12-12 |
| NAVISTAR RMT THERMOCOOL MAGNETIC STEERING CATHETERS (P030031/S036) | Biosense Webster, Inc. | 2011-12-12 |
| CELSIUS RMT THERMOCOOL MAGNETIC CATHETER (P040036/S027) | Biosense Webster, Inc. | 2011-12-12 |
| IMPLANTABLE INFUSION SYSTEM (P860004/S162) | Medtronic, Inc. | 2011-12-12 |
| CAPENTIER-EDWARDS PORCINE BIOPRSTHETIC (P870056/S044) | Edwards Lifesciences, LLC | 2011-12-12 |
| LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM (P000008/S026) | Medtimo, Inc. | 2011-12-09 |
| SCULPTRA AND SCULPTRA AESTHETIC (P030050/S009) | Q-Med AB | 2011-12-09 |
| UROLOGIX TARGIS SYSTEM (P970008/S058) | Urologix, LLC | 2011-12-09 |
| SYNCHROMED II PROGRAMMABLE PUMP (P860004/S158) | Medtronic, Inc. | 2011-12-09 |
| EXABLATE (P040003/S010) | Insightec, Ltd. | 2011-12-08 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S028) | Boston Scientific Corp | 2011-12-07 |
| CORONARY FLEXTOME CUTTING BALLOON (P950020/S047) | Boston Scientific Corp | 2011-12-07 |
| MODEL 2090 MEDTRONIC/VITATRON CARELINK PROGRAMMER (P890003/S239) | Medtronic, Inc. | 2011-12-07 |
| ASSURANT COBALT BALLOON LLIAC BALLOON-EXPANDABLE STENT SYSTEM (P110011/S001) | Medtronic, Ireland | 2011-12-07 |
| ISOMED REFILL KIT/BULK REFILL KIT/ISOMED CAP KIT (P990034/S026) | Medtronic, Inc. | 2011-12-07 |
| XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P110019/S004) | Abbott Vascular | 2011-12-07 |
| SYNCHROMED REFILL KIT/BULK REFILL KIT/SYNCHROMED CATHETER ACCESS PORT (CAP) KIT (P860004/S164) | Medtronic, Inc. | 2011-12-07 |
| BARD E-LUMINEXX VASCULAR STENT (P080007/S010) | Bard Peripheral Vascular, Inc. | 2011-12-07 |
| ADVISA & ENRHYTHM (P980035/S249) | Medtronic, Inc. | 2011-12-06 |
| SPECTRANETICS EXCIMER LASER (P910001/S050) | Spectranetics Corp. | 2011-12-06 |
| REVO MRI (P090013/S044) | Medtronic, Inc. | 2011-12-06 |
| CONSULTA CRT-P & SYNCRA CRT-P (P010015/S145) | Medtronic, Inc. | 2011-12-06 |
| AFX ENDOVASCULAR AAA SYSTEM (P040002/S035) | Endologix, LLC | 2011-12-06 |
| CONCERT II/CONSULTA/INSYNC II/III MARQUIS/MAXIMO/SENTRY/MAXIMO II PROTECTA/XT/INSYNC MARQUIS/INSYNC II PROTECT/CONCERTO (P010031/S280) | Medtronic Cardiac Rhythm Disease Management | 2011-12-06 |
| ENTRUST/INTRINSIC/MARQUIS/MAXIMO/MAXIMO II SECURA/VIRTUOSO II/INSYNC MARQUIS/VIRTUOSO/PROTECTA (P980016/S327) | Medtronic Cardiac Rhythm Disease Management | 2011-12-06 |
| ZENITH TX2 TAA ENDOVASCULAR GRAFT (P070016/S006) | William Cook Europe Aps | 2011-12-06 |
| MODEL 2490G MEDTRONIC CARELINK REMOTE HOME MONITOR/MODEL 2020A MEDTRONIC CARDIOSIGHT READER/MODEL 2020B CARELINK EXPRES (P890003/S238) | Medtronic, Inc. | 2011-12-06 |
| GEM 21SGROWTH FACTOR ENHANCED MATRIX (P040013/S017) | Lynch Biologics, LLC | 2011-12-06 |
| FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM (P100028/S001) | Cook Medical Incorporated | 2011-12-05 |
| EXPRESS 2 MONORAIL AND OVER-THE-WIRE (P020009/S080) | Boston Scientific Scimed, Inc. | 2011-12-05 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S082) | Boston Scientific Corp | 2011-12-05 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM GUIDWIRE WITH WIRECLIP TORQUER (P900056/S110) | Boston Scientific Corp | 2011-12-05 |
| CHILLI II COOLED ABLATION CATHETER & CABLE (P980003/S033) | Boston Scientific Corp | 2011-12-05 |
| EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S022) | Boston Scientific Corp | 2011-12-05 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S082) | Boston Scientific Scimed, Inc. | 2011-12-05 |
| S.M.A.R.T. CONTROL NITINOL STENT SYSTEM (P020036/S021) | Cordis US Corporation | 2011-12-05 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S111) | Boston Scientific Corp | 2011-12-05 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S094) | Boston Scientific Corp | 2011-12-05 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S027) | Boston Scientific Corp | 2011-12-05 |
| BLAZER II CARDIAC ABLATION CATHETER & CABLE (P920047/S050) | Boston Scientific Corp | 2011-12-05 |
| BLAZER II XP CARDIAC ABLATION CATHETER & CABLE (P020025/S032) | Boston Scientific | 2011-12-05 |
| RENEWAL TR CRT-P DEVICES (P030005/S080) | Guidant Corp. | 2011-12-05 |
| VARIOUS FAMILIES/MODELS OF TILDA BRADYCARDIA PACING LEADS (P950037/S099) | Biotronik, Inc. | 2011-12-02 |
| REALIZE ADJUSTABLE GASTRIC BANDS WITH INJECTION PORT & APPLIER (P070009/S014) | Obtech Medical GmbH | 2011-12-02 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S086) | Cochlear Americas | 2011-12-02 |
| VNS THERAPY SYSTEM (P970003/S141) | LivaNova USA, Inc. | 2011-12-02 |
| VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S028) | Vistakon, Division of Johnson & Johnson Vision Car | 2011-12-02 |
| VISTAKON (ETAFILCON A) BRAND CONTACT LENSES (N18033/S062) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2011-12-02 |
| VARIOUS FAMILIES/MODELS OF CELERITY CRT PACING LEADS (P070008/S027) | Biotronik, Inc. | 2011-12-02 |
| ARCHITECT ANTI-HCV (P050042/S014) | Abbott Laboratories, Inc. | 2011-12-01 |
| ARCHITECT CORE-M (P060035/S012) | Abbott Laboratories | 2011-12-01 |
| UNIFY FAMILY OF CRT-DS (P030054/S207) | ABBOTT MEDICAL | 2011-12-01 |
| FORTIFY FAMILY OF ICDS (P910023/S280) | ABBOTT MEDICAL | 2011-12-01 |
| ARCHITECT CORE (P080023/S010) | Abbott Laboratories | 2011-12-01 |
| CONCERTO II/CONSULTA/MAXIMO II/PROTECTA/PROTECTA XT (P010031/S279) | Medtronic Cardiac Rhythm Disease Management | 2011-11-30 |
| PARADYM CRT-D (P060027/S033) | MicroPort CRM USA, Inc. | 2011-11-30 |
| PARADYM VR & DR (P980049/S066) | MicroPort CRM USA, Inc. | 2011-11-30 |
| ABBOTT REALTIME HBV ASSAY (P080026/S002) | Abbott Molecular, Inc. | 2011-11-30 |
| HER2 CISH PHARMDX KIT (P100024) | Dako Denmark A/S | 2011-11-30 |
| MAXIMO II/PROTECTA/PROTECTA XT/SECURA/VIRTUOSO II (P980016/S326) | Medtronic Cardiac Rhythm Disease Management | 2011-11-30 |
| ABBOTT REALTIME HCV ASSAY (P100017/S001) | Abbott Molecular, Inc. | 2011-11-30 |