| KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM (P050027/S003) | KARL STORZ Endoscopy-America, Inc. | 2012-08-27 |
| ACUITY STEERABLE IMPLANTABLE LEADS (P050046/S015) | Guidant Corp. | 2012-08-27 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S028) | Abbott Vascular | 2012-08-27 |
| CRYOABLATION CONSOLE (P100010/S017) | Medtronic Cryocath, LP | 2012-08-24 |
| EON IMPLANTABLE PULSE GENERATOR (P010032/S057) | ABBOTT MEDICAL | 2012-08-24 |
| INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S024) | Integra Lifesciences Corp. | 2012-08-24 |
| INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S025) | Integra Lifesciences Corp. | 2012-08-24 |
| MULTI-LINK 8 CORONARY STENT SYSTEM (P020047/S050) | Abbott Vascular | 2012-08-24 |
| HIRESOLUTION BIONIC EAR SYSTEM (P960058/S097) | Advanced Bionics | 2012-08-24 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLQTINUM CHROMIUM STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) (P110010/S020) | Boston Scientific Corp | 2012-08-24 |
| RX ACCULINK CARTOID STENT SYSTEM (P040012/S044) | Abbott Vascular | 2012-08-24 |
| CRYOABLATION CONSOLE (P020045/S044) | Medtronic Cryocath, LP | 2012-08-24 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S092) | Cochlear Americas | 2012-08-24 |
| EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S010) | Exactech, Inc. | 2012-08-24 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S027) | Abbott Vascular | 2012-08-24 |
| ACTIVA IMPLAMTABLE NEUROSTIMULATORS: ACTIVA RC MODEL 37612, ACTIVA PC MODEL 37601, ACTIVA SC MODEL 37602 AND ACTIVA SC M (P960009/S149) | Medtronic, Inc. | 2012-08-24 |
| PARADYM CRT-D, PARADYM RF CRT-D (P060027/S045) | MicroPort CRM USA, Inc. | 2012-08-23 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE WIRE) (P110010/S021) | Boston Scientific Corp | 2012-08-23 |
| PROGEL PLEURAL AIR LEAK SEALANT DEVICE (P010047/S019) | Neomend, Inc. | 2012-08-23 |
| MOSIAC PORCINE BIOPROSTHESIS (P990064/S043) | Medtronic, Inc. | 2012-08-23 |
| PARADYM VR AND DR, PARADYM RF VR AND DR (P980049/S077) | MicroPort CRM USA, Inc. | 2012-08-23 |
| REPLY SR AND DR, ESPRIT SR AND DR (P950029/S071) | MicroPort CRM USA, Inc. | 2012-08-23 |
| INTERSTIM (P970004/S139) | Medtronic Neuromodulation | 2012-08-22 |
| ITREL 3, SYNERGY, SYNERGY VERSITREL, ITREL, POCKET ADAPTOR (P840001/S224) | Medtronic Neuromodulation | 2012-08-22 |
| MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S371) | Medtronic Cardiac Rhythm Disease Management | 2012-08-22 |
| AFX STAND-ALONE LIMB EXTENSION DELIVERY SYSTEM (P040002/S038) | Endologix, LLC | 2012-08-22 |
| ION PACLITAXEL-ELUTING CORONARY SYSTEM (MONORAIL AND OVER THE WIRE) (P100023/S051) | Boston Scientific Corp | 2012-08-22 |
| INTERSTIM (P080025/S036) | Medtronic Neuromodulation | 2012-08-22 |
| FORTIFY VR DF-4 FAMILY OF ICDS (P910023/S299) | ABBOTT MEDICAL | 2012-08-22 |
| THERAPY DUAL 8 CARDIAC ABLATION SYSTEM (P040042/S024) | Irvine Biomedical,Inc.(Ibi) | 2012-08-22 |
| CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S324) | Medtronic Cardiac Rhythm Disease Management | 2012-08-22 |
| COGNIS, INCEPTA, ENERGEN AND PUNCTUA CRT-D DEVICES (P010012/S297) | Boston Scientific Corp | 2012-08-22 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S169) | Medtronic, Inc. | 2012-08-22 |
| ADAPTA, ADAPTA L, ADAPTA S, SENSIA L, SENSIA, VERSA IPG (P980035/S283) | Medtronic, Inc. | 2012-08-22 |
| TELIGEN, INCEPTA, ENERGEN AND PUNCTUA ICD DEVICES (P960040/S267) | Boston Scientific | 2012-08-22 |
| INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S022) | Integra Lifesciences Corp. | 2012-08-22 |
| SOLETRA, KINETRA, ACTIVA SC, POCKET ADAPTOR (P960009/S153) | Medtronic, Inc. | 2012-08-22 |
| THERAPY CARDIAC ABLATION SYSTEM (P040014/S019) | Irvine Biomedical, Inc. | 2012-08-22 |
| THERAPY COOL PATH ABLATION CATHETER & IBI 1500T9 (P060019/S020) | Irvine Biomedical, Inc. | 2012-08-22 |
| AMS SPHINCTER 800 URINARY PROSTHESIS (P000053/S041) | Boston Scientific Corp | 2012-08-21 |
| PATWAY HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S012) | Ventana Medical Systems, Inc. | 2012-08-21 |
| SYNCHROMED II INFUSION PUMP (P860004/S173) | Medtronic, Inc. | 2012-08-21 |
| SYNCHROMED II INFUSION PUMP (P860004/S174) | Medtronic, Inc. | 2012-08-21 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S008) | Edwards Lifesciences, LLC | 2012-08-20 |
| SYNCARDIA COMPANION 2 DRIVER SYSTEM (P030011/S016) | Syncardia Systems, LLC | 2012-08-20 |
| ION PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM (P100023/S033) | Boston Scientific Corp | 2012-08-20 |
| ENTRUST ICD, INTRINSIC ICD, MARQUIS DR ICD, MARQUIS VR ICD, MAXIMO DR ICD, MAXIMO II DF4 ICD, MAXIMO II ICD (P980016/S369) | Medtronic Cardiac Rhythm Disease Management | 2012-08-20 |
| CONCERTO ICD, CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, INSYNC III MARQUIS ICD, INSYNC MAXIMO ICD, MAXIMO II DF (P010031/S322) | Medtronic Cardiac Rhythm Disease Management | 2012-08-20 |
| XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S014) | Abbott Vascular | 2012-08-20 |
| VIATRON C20 SR IPG, VITATRON C60 DR IPG, VIATRON T20 SR IPG, VIATRON T60 DR IPG (P990001/S106) | Medtronic, Inc. | 2012-08-20 |
| REVO MRI IPG, RVDR01 (P090013/S067) | Medtronic, Inc. | 2012-08-20 |
| HARMONY HIRESOLUTION BIONIC EAR SYSTEM (P960058/S096) | Advanced Bionics | 2012-08-20 |
| MULTI-LINK 8 AND MULTI-LINK 8 LL CORONARY STENT SYSTEM (CSS) (P020047/S046) | Abbott Vascular | 2012-08-20 |
| ADAPTA, ADAPTA L, ADAPTA S, SENSIA L, SENSIA, VERSA IPG (P980035/S281) | Medtronic, Inc. | 2012-08-20 |
| CONSULTA CRT-P, C4TR01, SYNCRA CRT-P, C2TR01 (P010015/S167) | Medtronic, Inc. | 2012-08-20 |
| EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S008) | Exactech, Inc. | 2012-08-17 |
| EN TRUST ICD, INTRINSIC ICD, MARQUIS DR ICD, MARQUIS VR ICD, MAXIMO DR ICD, MAXIMO DR ICD, MAXIMO II DF4 ICD, MAXIMO II (P980016/S370) | Medtronic Cardiac Rhythm Disease Management | 2012-08-17 |
| MINILINK REAL-TIME TRANSMITTER (MMT-7703) (P980022/S120) | Medtronic Minimed | 2012-08-17 |
| CONSULTA CRT-P, C4TR01, SYNCRA CRT-P C2TR01 (P010015/S168) | Medtronic, Inc. | 2012-08-17 |
| ADAPTA, ADAPTA L, ADAPTA S, SENSIA L, SENSIA, VERSA IPG (P980035/S282) | Medtronic, Inc. | 2012-08-17 |
| CONCERTO ICD,CONCERTO II CRT-D, CONSULTA DF4 ICD,CONSULTA, INSYNC III MARQUIS ICD, INSYNC MAXIMO ICD, MAXIMO II CRT-D, (P010031/S323) | Medtronic Cardiac Rhythm Disease Management | 2012-08-17 |
| VITATRON C20 SR IPG, VITATRON C60 DR IPG, VITATRON T20 SR IPG, VITATRON T60 DR IPG (P990001/S107) | Medtronic, Inc. | 2012-08-17 |
| DEXCOM CGM (P050012/S045) | Dexcom, Inc. | 2012-08-17 |
| REVO MRI IPG, RVDR01 (P090013/S068) | Medtronic, Inc. | 2012-08-17 |
| ENDURANT STENT GRAFT SYSTEM (P100021/S015) | Medtronic Vascular | 2012-08-16 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM (P110010/S010) | Boston Scientific Corp | 2012-08-16 |
| COMPLETE SE VASCULAR STENT SYSTEM (P090006/S008) | Medtronic Vascular | 2012-08-16 |
| VALIANT THORACIC STENT GRAFT WITH THE CAPTIVA DELIVERY SYSTEM (P100040/S007) | Medtronic Vascular | 2012-08-16 |
| TALENT ABDOMINAL STENT GRAFT WITH THE XCELERANT HYDRO DELIVER SYSTEM (P070027/S034) | Medtronic Vascular | 2012-08-16 |
| ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM (P110011/S002) | Medtronic, Ireland | 2012-08-16 |
| RESOLUTE INTEGRITY & MICROTRAC ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P110013/S001) | Medtronic Vascular | 2012-08-16 |
| DRIVER AND MICRO-DRIVER AND INTEGRITY CORONARY STENT SYSTEMS (P030009/S061) | Medtronic, Ireland | 2012-08-16 |
| SOFTEC HD POSTERRIOR CHAMBER INTRAOCULAR LENS (PCIOL) (P090022/S013) | Lenstec, Inc. | 2012-08-16 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S070) | Medtronic, Inc. | 2012-08-16 |
| TALENT THORACIC STENT GRAFT SYSTEM WITH THE XCELERANT AND CAPTIVA DELIVERY SYSTEM (P070007/S035) | Medtronic Vascular | 2012-08-16 |
| MEDTRONIC ATTAIN STARFIX MODEL 4195 LEAD (P060039/S033) | Medtronic, Inc. | 2012-08-16 |
| ANEURX AAAADVANTAGE STENT GRAFT WITH XCELERANT HYDRO DELIVERY SYSTEM (P990020/S047) | Medtronic Vascular | 2012-08-16 |
| ION PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM (P100023/S038) | Boston Scientific Corp | 2012-08-16 |
| OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S037) | Biomet Manufacturing Corp | 2012-08-15 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S035) | Zoll Manufacturing Corporation | 2012-08-15 |
| PRECIOUS SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S139) | Boston Scientific Corp | 2012-08-15 |
| CAPSUREFIX (P930039/S070) | Medtronic, Inc. | 2012-08-15 |
| ATRICURE SYNERGY ABLATION SYSTEM (P100046/S001) | AtriCure, Inc. | 2012-08-15 |
| XIENCE V AND NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S097) | Abbott Vascular, Inc. | 2012-08-14 |
| CAPSUREFIX MRI (P090013/S066) | Medtronic, Inc. | 2012-08-14 |
| MAXIMO II DF4 CRT-D, DF4 ICD, ICD, SECURA DF4 ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S368) | Medtronic Cardiac Rhythm Disease Management | 2012-08-14 |
| VISION AND MINI-VISION CORONARY STENT SYSTEM (P020047/S049) | Abbott Vascular | 2012-08-14 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CHRONIUM CORONARY STENT SYSTEM (P110010/S025) | Boston Scientific Corp | 2012-08-14 |
| ADVIA CENTAUR AFP REAGENTS AND CALIBRATORS (P930036/S004) | Siemens Healthcare Diagnostics, Inc. | 2012-08-14 |
| MULTI-LINK 8 CORONARY STENT SYSTEM (CSS) (P970020/S074) | Abbott Vascular, Inc. | 2012-08-14 |
| HERCULINK ELITE RX STENT SYSTEM (P110001/S008) | Abbott Vascular | 2012-08-14 |
| ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S050) | Boston Scientific Corp | 2012-08-14 |
| EXOSEAL VASCULAR CLOSURE DEVICE (P100013/S005) | Cordis US Corporation | 2012-08-14 |
| XIENCE PRIME AND PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P110019/S026) | Abbott Vascular | 2012-08-14 |
| INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S023) | Integra Lifesciences Corp. | 2012-08-14 |
| CONCERTO II CRT-D, CONSULTA DF4 ICD, ICD, MAXIMO IICRT-D, MAXIMO IIDF4 CRT-D (P010031/S321) | Medtronic Cardiac Rhythm Disease Management | 2012-08-14 |
| MEDTRONIC OPEN PIVOT HEART VALVE (P990046/S026) | Medtronic Ats Medical, Inc. | 2012-08-13 |
| EON, EONC AND EON MINI NEUROSTIMULATION SYSTEMS (P010032/S060) | ABBOTT MEDICAL | 2012-08-10 |
| CONCERTO II CRT-D, CONSULTA DF4 ICD, ICD, MAXIMO IICRT-D, MAXIMO IIDF4 CRT-D (P010031/S320) | Medtronic Cardiac Rhythm Disease Management | 2012-08-10 |
| ADAPTA/VERSA/ENSIA IPG, RELIA IPG (P980035/S278) | Medtronic, Inc. | 2012-08-10 |