| EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,MAXIMO II ICD,PROTECTA ICD,PROTECTA XT ICD,SECURA ICD,VIRT (P980016/S414) | Medtronic Cardiac Rhythm Disease Management | 2013-05-14 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S049) | W. L. Gore & Associates, Inc. | 2013-05-14 |
| CADENCE, CADET, CONTOUR, CONTOUR 11/MD, ADGSTROM II/MD, PROFILEII/MD, PHOTON, PHOTON MICRO (P910023/S314) | ABBOTT MEDICAL | 2013-05-14 |
| BRAVA CRT-D,CONCERTO II CRT-D,CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA S CRT-D,VIVA XT CRT-D (P010031/S374) | Medtronic Cardiac Rhythm Disease Management | 2013-05-14 |
| EPIC HF, EPIC + HR, EPIC II HF, EPIC II+ HF, ATLAS HF, ATLAS+HF, ATLAS II +HF, ATLAS, PROMOTE, PROMOTE + (P030054/S245) | ABBOTT MEDICAL | 2013-05-14 |
| REVO MRI SURESCAN PACKING SYSTEM (P090013/S092) | Medtronic, Inc. | 2013-05-14 |
| COBAS EGFR MUTATION TEST (P120019) | Roche | 2013-05-14 |
| ADVISA DR IPG,ADVISA DR MRI IPG (P980035/S322) | Medtronic, Inc. | 2013-05-14 |
| ELECSCYS HBSAG IMMUNOASSAY, ELECSYS PRECICONTROL HBSAG, ELECSYS HBSAG CONFIRMATORY TEST (P990012/S016) | Roche Diagnostics Corp. | 2013-05-14 |
| PATHWAY ANTI-HER-2/NEU (4B5)RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S018) | Ventana Medical Systems, Inc. | 2013-05-13 |
| INFORM HER2 DUAL ISH DNA PROBE COCTAIL (P100027/S008) | Ventana Medical Systems, Inc. | 2013-05-13 |
| PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY (P020055/S007) | Ventana Medical Systems, Inc. | 2013-05-13 |
| PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S018) | Smiths Medical Asd, Inc. | 2013-05-13 |
| SURESCAN MRI IMPLANTABLE NEUROSTIMULATION SYSTEM (P840001/S238) | Medtronic Neuromodulation | 2013-05-10 |
| EXOSEAL VASCULAR CLOSURE DEVICE (P100013/S009) | Cordis US Corporation | 2013-05-09 |
| ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT (P020018/S048) | Cook, Inc. | 2013-05-09 |
| PARADYM RF CRT-D (P060027/S038) | MicroPort CRM USA, Inc. | 2013-05-09 |
| PIPELINE EMBOLIZATION DEVICE, PIPELINE EMBOLIZATION DEVICE (P100018/S007) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2013-05-09 |
| PARADYM RF VR ICDS (P980049/S071) | MicroPort CRM USA, Inc. | 2013-05-09 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM (P110042/S005) | Boston Scientific Corporation | 2013-05-09 |
| BELOS VR-T (P980023/S052) | Biotronik, Inc. | 2013-05-08 |
| INTEGRITY CORONARY STENT SYSTEMS (P030009/S064) | Medtronic, Ireland | 2013-05-08 |
| PHILOS DR-T,PHILOS II DR-T,CYLOS DR-T,EVIA DR-T/EVIA SR-T,ENTOVIS DR-T/ENTOVIS SR-T,ESTELLA DR-T/ESTELLA SR-T (P950037/S121) | Biotronik, Inc. | 2013-05-08 |
| BELOS DR-T,BELOS A+-T,LEXOS DR-T/LEXOS VR-T,XELOS DR-T,LUMOS DR-T/LUMOS VR-T (P000009/S054) | Biotronik, Inc. | 2013-05-08 |
| LUMAX 300 DR-T/LUMAX 340 DR-T,LUMAX 300 VR-T/LUMAX 340 VR-T,LUMAX 500 DR-T/LUMAX 540 DR-T,LUMAX 500 VR-T/LUMAX 540 VR-T, (P050023/S063) | Biotronik, Inc. | 2013-05-08 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P110013/S010) | Medtronic Vascular | 2013-05-08 |
| VIFILCON A CONTACT LENSES FOR EXTENDED WEAR (P820021/S036) | Alcon Laboratories, Inc. | 2013-05-08 |
| PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMS (P030017/S156) | Boston Scientific Corp | 2013-05-08 |
| STRATOS LV-T,EVIA HF-T (P070008/S041) | Biotronik, Inc. | 2013-05-08 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S074) | Medtronic, Inc. | 2013-05-08 |
| GENESIS, GENESISRC AND GENESIS XP NEUROSTIMULATION SYSTEMS (P010032/S061) | ABBOTT MEDICAL | 2013-05-08 |
| HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD) (P110007/S004) | Johnson & Johnson Surgical Vision, Inc. | 2013-05-08 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S371) | Medtronic Cardiac Rhythm Disease Management | 2013-05-07 |
| FLEXTEND LEAD (P960006/S038) | Boston Scientific | 2013-05-07 |
| ADVISA MRI (P980035/S318) | Medtronic, Inc. | 2013-05-07 |
| RELIANCE IS-1/DF-1 LEAD AND RELIANCE 4-SITE LEAD (P910073/S116) | Boston Scientific | 2013-05-07 |
| CCOBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0 (P050028/S031) | Roche Molecular Systems, Inc. | 2013-05-07 |
| HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE (P060040/S023) | ABBOTT MEDICAL | 2013-05-07 |
| CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S013) | DePuy Orthopaedics, Inc. | 2013-05-07 |
| BIOFINITY (P080011/S023) | CooperVision, Inc. | 2013-05-07 |
| EVERA S DR, EVERA S VR, EVERA XT DR, EVERA XT VR (P980016/S410) | Medtronic Cardiac Rhythm Disease Management | 2013-05-07 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S109) | Cochlear Americas | 2013-05-06 |
| THERAKOS CELLEX INSTRUMENT, THERAKOS CELLEX PHOTOPHERESIS PROCEDURAL KIT (125ML) THERAKOS CELLEX LIGHT ASSEMBLY (P860003/S073) | Therakos Development Limited | 2013-05-06 |
| EVERA S DR, EVERA S VR, EVERA XT DR (P980016/S408) | Medtronic Cardiac Rhythm Disease Management | 2013-05-03 |
| COBAS AMPLIPREP/COBAS TAQMAN HBV V2.0 (P050028/S030) | Roche Molecular Systems, Inc. | 2013-05-03 |
| NUVASIVE PCM CERVICAL DISC (P100012/S004) | Nuvasive, Inc. | 2013-05-03 |
| CONCERTO ICD,CONCERTO II CRT-D,CONSULTA DF4 ICD,CONSULTA ICD,INSYNC III MARQUIS ICD,INSYNC MAXIMO ICD,BRAVA CRT-D,VIVA S (P010031/S370) | Medtronic Cardiac Rhythm Disease Management | 2013-05-03 |
| PARADYM CRT-D, PARADYM RF CRT-D (P060027/S050) | MicroPort CRM USA, Inc. | 2013-05-03 |
| PARADYM VR AND DR, PARADYM RF VR AND DR (P980049/S082) | MicroPort CRM USA, Inc. | 2013-05-03 |
| EVERA S DR, EVERA S VR, EVERA XT DR (P980016/S409) | Medtronic Cardiac Rhythm Disease Management | 2013-05-03 |
| INTRINSIC ICD,MARQUIS DR ICD,MARQUIS VR ICD,MAXIMO DR ICD,MAXIMO II ICD,PROTECTA ICD,PROTECTA XT ICD, SECURA ICD,VIRTUOS (P980016/S407) | Medtronic Cardiac Rhythm Disease Management | 2013-05-03 |
| VNS THERAPY SYSTEM LEADS (P970003/S161) | LivaNova USA, Inc. | 2013-05-03 |
| ENDURANT II STENT GRAFT SYSTEM (P100021/S024) | Medtronic Vascular | 2013-05-03 |
| SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM (P080009) | Scott Laboratories, Inc. | 2013-05-03 |
| VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM (P100040/S011) | Medtronic Vascular | 2013-05-02 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S048) | W. L. Gore & Associates, Inc. | 2013-05-02 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S029) | W. L. Gore & Associates, Inc. | 2013-05-02 |
| VNS THERAPY ACCESSORY PACK (P970003/S158) | LivaNova USA, Inc. | 2013-05-02 |
| GORE TAG THORACIC ENDOPROSTHESEIS (P040043/S052) | W. L. Gore & Associates, Inc. | 2013-05-02 |
| TALENT AAA STENT GRAFT WITH XCELERANT HYDRO DELIVERY SYSTEM (P070027/S036) | Medtronic Vascular | 2013-05-02 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S081) | W. L. Gore & Associates, Inc. | 2013-05-02 |
| TALENT THORACIC STENT GRAFT SYSTEM (P070007/S037) | Medtronic Vascular | 2013-05-02 |
| ENDURANT STENT GRAFT SYSTEM (P100021/S025) | Medtronic Vascular | 2013-05-02 |
| THERAKOS CELLEX PHOTOPHRESES SYSTEM (P860003/S068) | Therakos Development Limited | 2013-05-01 |
| GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM (P080030/S008) | Glaukos Corporation | 2013-05-01 |
| SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (STAR ANKLE) (P050050/S004) | Djo Global | 2013-05-01 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S097) | Boston Scientific Corp | 2013-05-01 |
| PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S161) | Boston Scientific Corp | 2013-05-01 |
| LATITUDE PATIENT MANAGEMENT SYSTEM (P910077/S131) | Boston Scientific | 2013-04-30 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S040) | Medtronic, Inc. | 2013-04-30 |
| CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S369) | Medtronic Cardiac Rhythm Disease Management | 2013-04-30 |
| HANCOCK II PORCINE BIOPROSTHESIS, MODELS T505 AND T510 (P980043/S040) | Medtronic, Inc. | 2013-04-30 |
| HANCOCK LOW POROSITY VALVED CONDUIT (P870078/S019) | Medtronic, Inc. | 2013-04-30 |
| PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S162) | Boston Scientific Corp | 2013-04-30 |
| PUNCTUA, TELIGEN, ENERGEN, INCEPTA ICD'S (P960040/S293) | Boston Scientific | 2013-04-30 |
| AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S048) | Boston Scientific Corp | 2013-04-30 |
| MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S406) | Medtronic Cardiac Rhythm Disease Management | 2013-04-30 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S007) | Boston Scientific Corporation | 2013-04-30 |
| HANCOCK MODIFIED ORIFICE VALVED CONDUIT, MODEL 150 (P790007/S036) | Medtronic Heart Valves | 2013-04-30 |
| PUNCTUA, COGNIS, ENERGEN, INCEPTA CRT-D'S (P010012/S328) | Boston Scientific Corp | 2013-04-30 |
| MOSAIC PORCINE BIOPROSTHESIS, MODELS 305 AND 310 (P990064/S048) | Medtronic, Inc. | 2013-04-30 |
| FLAIR ENDOVASCULAR STENT GRAFT (P060002/S031) | Bard Peripheral Vascular | 2013-04-29 |
| VISTAKON (ETAFILCON A) BRAND CONTACT LENSES (N18033/S072) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2013-04-29 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S030) | W. L. Gore & Associates, Inc. | 2013-04-29 |
| VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S039) | Vistakon, Division of Johnson & Johnson Vision Car | 2013-04-29 |
| PUNCTUA, COGNIS, ENERGEN, AND INCEPTA CRT-DS (P010012/S325) | Boston Scientific Corp | 2013-04-26 |
| PUNCTUA, TELIGEN, ENERGEN AND INCEPTA ICDS (P960040/S290) | Boston Scientific | 2013-04-26 |
| PUNCTUA, TELIGEN, ENERGEN AND INCEPTA ICDS (P960040/S292) | Boston Scientific | 2013-04-26 |
| INCEPTA,ENERGEN,PUNCTUA,COGNIS CRT-DS (P010012/S327) | Boston Scientific Corp | 2013-04-26 |
| EVERA S DR (P980016/S411) | Medtronic Cardiac Rhythm Disease Management | 2013-04-26 |
| CELCIUS DS CATHETER, NAVISTAR DS CATHETER, NAVISTAR RMT DS CATHETER, EZ STEER NAV DS CATHETER (P010068/S033) | Biosense Webster, Inc. | 2013-04-25 |
| OXFORD PARTIAL KNEE SYSTEM (P010014/S042) | Biomet Manufacturing Corp | 2013-04-25 |
| BIOSENSE WEBSTER CABLES (P990071/S022) | Biosense Webster, Inc. | 2013-04-25 |
| XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY SYSTEM, XIENC (P110019/S041) | Abbott Vascular | 2013-04-25 |
| NAVISTAR THERMOCOOL CATHETER,NAVISTAR RMT THERMOCOOL,EZ STEER THERMOCOOL CATHETER,EZ STEER THERMOCOOL NAV CATHETER (P040036/S035) | Biosense Webster, Inc. | 2013-04-25 |
| CELCIUS CATHETER,CELCIUS RMT CATHETER,EZ STEER CATHETER,EZ STEER DS CATHETER,DEFLECTABLE DIAGNOSTIC/ABLATION CATHETERS,B (P950005/S043) | Biosense Webster, Inc. | 2013-04-25 |
| CELCIUS THERMOCOOL CATHETER, CELCIUS RMT THERMOCOOL CATHETER,NAVISTAR THERMOCOOL CATHETER,NAVISTAR RMT THERMOCOOL (P030031/S051) | Biosense Webster, Inc. | 2013-04-25 |
| NAVISTAR CATHETER,NAVISTAR RMT CATHETER,EZ STEER NAV CATHETER,BIOSENSE WEBSTER CABLES (P990025/S036) | Biosense Webster, Inc. | 2013-04-25 |
| INVIVE CARDIAC RESYNCHRONIZATION THERAPY -PACEMAKER (CRT-P) (P030005/S097) | Guidant Corp. | 2013-04-25 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S023) | Edwards Lifesciences, LLC | 2013-04-24 |