| THORATEC VENTRICULAR ASSIST DEVICE (P870072/S048) | Thoratec Laboratories Corp. | 2012-06-18 |
| IMPLANTABLE SYNCHROMED II INFUSION PUMP (P860004/S171) | Medtronic, Inc. | 2012-06-18 |
| BARD E-LUMINEXXVASCULAR STENT (P080007/S014) | Bard Peripheral Vascular, Inc. | 2012-06-18 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S021) | Abbott Vascular | 2012-06-18 |
| ELECSYS ANTI-HBC-IGM ON MODULAR ANALYTICS E170 (P110025/S001) | Roche Diagnostics Corp. | 2012-06-18 |
| BARD FLAIR ENDOVASCULAR STENT GRAFT (P060002/S026) | Bard Peripheral Vascular | 2012-06-18 |
| AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS (P060022/S012) | Bausch & Lomb, Inc. | 2012-06-18 |
| ELECSYS ANTI-HBC-IGM ON COBAS E 601 (P110022/S001) | Roche Diagnostics Corp. | 2012-06-18 |
| PINNACLE COMPLETE ACETABULAR HIP SYSTEM (P090002/S004) | DePuy Orthopaedics, Inc. | 2012-06-15 |
| THERMOCOOL SF BI-DIRECTIONAL AND UNI-DIRECTIONAL CATHETERS (P030031/S039) | Biosense Webster, Inc. | 2012-06-15 |
| HIRESOLUTION BIONIC EAR SYSTEM (P960058/S095) | Advanced Bionics | 2012-06-15 |
| PROTECTA DF4 ICD, PROTECTA ICD, PROTECTA XT DF4 ICD, PROTECTA ICD, PROTECTA XT DF4 ICD, PROTECTA XT ICD (P980016/S355) | Medtronic Cardiac Rhythm Disease Management | 2012-06-15 |
| DUROLOC OPTION CERAMIC HIP SYSTEM (P040023/S022) | DePuy Orthopaedics, Inc. | 2012-06-15 |
| SCS INS ITREL FAMILY, SCS INS SYNERGY FAMILY (P840001/S217) | Medtronic Neuromodulation | 2012-06-15 |
| DBS INS SOLETRA FAMILY, DBS INS KINETRA FAMILY (P960009/S148) | Medtronic, Inc. | 2012-06-15 |
| PROTECTA CRT-D, PROTECTA DF4 CRT-D, PROTECTA XT CRT-D, PROTECTA XT DF4 CRT-D (P010031/S308) | Medtronic Cardiac Rhythm Disease Management | 2012-06-15 |
| DURALOC OPTION CERAMIC HIP SYSTEM (P040023/S021) | DePuy Orthopaedics, Inc. | 2012-06-15 |
| DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S006) | DePuy Orthopaedics, Inc. | 2012-06-15 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S163) | Medtronic, Inc. | 2012-06-14 |
| AMVISC & AMVISC PLUS (P810025/S027) | Bausch & Lomb, Inc. | 2012-06-14 |
| AUTODELFIA HAFP TEST SYSTEM (P970037/S008) | Revvity, Inc. | 2012-06-14 |
| ADVISA DR IPG (P980035/S271) | Medtronic, Inc. | 2012-06-14 |
| FREEZOR CARDIAC CRYOABLATION CATHETERS, FREEZOR XTRA AND FREEZOR MAX SURGICAL CRYOABLATION DEVICES (P020045/S043) | Medtronic Cryocath, LP | 2012-06-14 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (P110023/S002) | Medtronic Vascular, Inc. | 2012-06-14 |
| ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS (P090026) | Beckman Coulter, Inc. | 2012-06-14 |
| EXPANSION OF LATHE LINES FOR INTRAOCULAR LENS MANUFACTURING (P080004/S008) | Hoya Surgical Optics, Inc. | 2012-06-13 |
| PROTECTA XT VR DF4, PROTECTA VR DF4, SECURA VR DF4, & MAXIMO II VR DF4 ICD'S (P980016/S353) | Medtronic Cardiac Rhythm Disease Management | 2012-06-13 |
| PARADYM VR, DR RF VR & RF DR (P980049/S073) | MicroPort CRM USA, Inc. | 2012-06-11 |
| SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL) (P090022/S011) | Lenstec, Inc. | 2012-06-11 |
| SECURA, MAXIMOII, PROTECTA, PROTECTA XT (P980016/S354) | Medtronic Cardiac Rhythm Disease Management | 2012-06-11 |
| CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT (P010031/S307) | Medtronic Cardiac Rhythm Disease Management | 2012-06-11 |
| REPLY SR AND DR, ESPRIT SR AND DR (P950029/S068) | MicroPort CRM USA, Inc. | 2012-06-11 |
| PARADYM CRT-D, RF CRT-D (P060027/S040) | MicroPort CRM USA, Inc. | 2012-06-11 |
| IMPLANTABLE COLLAMER LENS (VISIAN ICL) (P030016/S023) | STAAR Surgical Company | 2012-06-08 |
| RESTORE, ITREL, SYNERGY (P840001/S215) | Medtronic Neuromodulation | 2012-06-08 |
| HER2 FISH PHARMADX KIT (P040005/S006) | Agilent Technologies Singapore (International) Pte , Ltd. | 2012-06-08 |
| ACTIVA, SOLETRA, KINETRA (P960009/S146) | Medtronic, Inc. | 2012-06-08 |
| HERCEP TEST (P980018/S015) | Agilent Technologies Singapore (International) Pte , Ltd. | 2012-06-08 |
| ON-X PROSTHETIC HEART VALVE (P000037/S025) | On-X Life Technologies, Inc. | 2012-06-08 |
| INTERSTIM (P970004/S135) | Medtronic Neuromodulation | 2012-06-08 |
| INTERSTIM (P080025/S032) | Medtronic Neuromodulation | 2012-06-08 |
| SYNCHROMED IMPLANTABLE INFUSION PUMP (P860004/S169) | Medtronic, Inc. | 2012-06-07 |
| COBAS AMPLIPREP / COBAS AMPLICOR HCV V2.0 AND COBAS AMPLICOR HCV TEST, V2.0 (P000012/S038) | Roche Molecular Systems, Inc. | 2012-06-07 |
| SIENTRA SILICONE GEL BREAST IMPLANTS (P070004/S004) | Tiger Aesthetics Medical, LLC | 2012-06-07 |
| DBS IMPLANTABLE NEUROSTIMULATORS (P960009/S147) | Medtronic, Inc. | 2012-06-07 |
| XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P110019/S019) | Abbott Vascular | 2012-06-07 |
| ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (P110028/S001) | Abbott Vascular, Inc. | 2012-06-07 |
| JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S025) | Allergan | 2012-06-07 |
| VYSIS ALK BREAK APART FISH PROBE KIT (P110012/S001) | Abbott Molecular, Inc. | 2012-06-07 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST AND COBAS TAQMAN HCV TEST FOR USE WITH THE HIGH PURE SYSTEM (P060030/S025) | Roche Molecular Systems, Inc. | 2012-06-07 |
| SNS URINARY INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P970004/S136) | Medtronic Neuromodulation | 2012-06-07 |
| SNS BOWEL INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P080025/S033) | Medtronic Neuromodulation | 2012-06-07 |
| COBAS HPV TEST (P100020/S003) | Roche Molecular Systems, Inc. | 2012-06-07 |
| ACRYSOF TORIC HIGH CYLINDER POWER IOL (P930014/S058) | Alcon Laboratories, Inc. | 2012-06-07 |
| ENDURANT STENT GRAFT SYSTEM (P100021/S017) | Medtronic Vascular | 2012-06-07 |
| HERCULINK ELITE RENAL STENT SYSTEM (P110001/S004) | Abbott Vascular | 2012-06-07 |
| SCS IMPLANTABLE NEUROSTIMULATORS (P840001/S216) | Medtronic Neuromodulation | 2012-06-07 |
| COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM AND COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0 (P050028/S024) | Roche Molecular Systems, Inc. | 2012-06-07 |
| AMPLATZER SEPTAL AND CRIBRIFORM OCCLUDERS (P000039/S046) | ABBOTT MEDICAL | 2012-06-06 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S001) | Boston Scientific Corp | 2012-06-06 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S021) | ABBOTT MEDICAL | 2012-06-06 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (P110023/S001) | Medtronic Vascular, Inc. | 2012-06-06 |
| ULTRASOUND BONE HEALING SYSTEM (P900009/S033) | Bioventus, LLC | 2012-06-06 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S135) | Boston Scientific Corp | 2012-06-06 |
| WALLSTENT TIPS ENDOPROSTHESIS (P930031/S031) | Boston Scientific Corp | 2012-06-06 |
| WALLSTENT VENOUS ENDOPROSTHESIS (P980033/S020) | Boston Scientific Corporation | 2012-06-06 |
| SELECTSECURE (P030036/S039) | Medtronic Cardiac Rhythm Disease Management | 2012-06-06 |
| AMPLATZER DUCT OCCLUDER (P020024/S036) | ABBOTT MEDICAL | 2012-06-06 |
| SYNCHROMED II INFUSION PUMP (P860004/S170) | Medtronic, Inc. | 2012-06-06 |
| ACTIVA IMPLANTABLE NEUROSTIMULATORS (P960009/S145) | Medtronic, Inc. | 2012-06-05 |
| INTERSTIM THERAPY (P080025/S031) | Medtronic Neuromodulation | 2012-06-05 |
| SYNCHROMED DRUG PUMPS (P860004/S168) | Medtronic, Inc. | 2012-06-05 |
| RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P840001/S214) | Medtronic Neuromodulation | 2012-06-05 |
| TAPSCOPE 550 (P860008/S021) | Cardio Command | 2012-06-05 |
| THORATEC HEARTMATE II LVAS (P060040/S015) | ABBOTT MEDICAL | 2012-06-05 |
| THORATEC HEARTMATE II LVAS (P060040/S021) | ABBOTT MEDICAL | 2012-06-05 |
| INTERSTIM IMPLANTABLE (P970004/S134) | Medtronic Neuromodulation | 2012-06-05 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S157) | Medtronic, Inc. | 2012-06-04 |
| ADVISA DR IPG (P980035/S264) | Medtronic, Inc. | 2012-06-04 |
| CONCERTO II CRT-D, CONSULTA, CONSULTA DF4, MAXIMO II CRT-D/DF4, PROTECTA CRT-D/DF4/XT CRT-D/XT DF4 (P010031/S306) | Medtronic Cardiac Rhythm Disease Management | 2012-06-04 |
| CONCERT II, CONSULTA, & MAXIMO II CRT-DS (P010031/S296) | Medtronic Cardiac Rhythm Disease Management | 2012-06-04 |
| INCEPTA, ENERGEN AND PUNTUA ICD DEVICES (P960040/S260) | Boston Scientific | 2012-06-04 |
| CARELINK DEVICE DATA MANAGEMENT APPLICATION (MODEL 2491) (P890003/S247) | Medtronic, Inc. | 2012-06-04 |
| MAXIMO II DF4/ICD, PROTECTA DF4/ICD/XT DF4/XT ICD, SECURA DF4/ ICD & VIRTUOSO II DR/VR ICD (P980016/S352) | Medtronic Cardiac Rhythm Disease Management | 2012-06-04 |
| INCEPTA, ENERGEN AND PUNCTUA CRT-D DEVICES (P010012/S290) | Boston Scientific Corp | 2012-06-04 |
| MAXIMO II, SECURA & VIRTUOSO II DR/VR ICDS (P980016/S343) | Medtronic Cardiac Rhythm Disease Management | 2012-06-04 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S028) | W. L. Gore & Associates, Inc. | 2012-06-01 |
| TOP2A FISH PHARMADX KIT (P050045/S004) | Dako Denmark A/S | 2012-06-01 |
| AFX ENDOVASCULAR AAA SYSTEM (P040002/S037) | Endologix, LLC | 2012-06-01 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S001) | Boston Scientific Corp | 2012-06-01 |
| XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S071) | Abbott Vascular, Inc. | 2012-05-31 |
| THORATEC HEARTMATE II VAS (P060040/S020) | ABBOTT MEDICAL | 2012-05-31 |
| RADIESSE INJECTABLE IMPLANT (P050037/S031) | Merz North America, Inc. | 2012-05-30 |
| VERIFLEX MONORAIL & OVER-THE-WIRE CORONARY STENT SYSTEM (P040016/S088) | Boston Scientific Scimed, Inc. | 2012-05-30 |
| EN VISTA ONE PEICE HYDROPHOBIC ACRYLIC LENS, MODEL MX60 (P910056/S010) | Bausch & Lomb, Inc. | 2012-05-30 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S028) | Boston Scientific Corp | 2012-05-30 |
| RADIESSE INJECTABLE IMPLANT (P050052/S034) | Merz North America, Inc. | 2012-05-30 |
| MODEL 74001 1X4 POCKET ADAPTOR FOR SPINAL CORD STIMULATION;MODEL 74002 2X4 POCKET ADAPTOR FOR SPINAL CORD STIMULATION (P840001/S213) | Medtronic Neuromodulation | 2012-05-30 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S089) | Edwards Lifesciences, LLC | 2012-05-30 |
| MODEL 640011X4 POCKET ADAPTOR FOR DEEP BRAIN STIMULATION;MODEL 64002 2X4 POCKET ADAPTOR FOR DEEP BRAIN STIMULATION (P960009/S144) | Medtronic, Inc. | 2012-05-30 |