| VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR (P000044/S030) | Ortho-Clinical Diagnostics, Inc. | 2012-11-13 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR (P090028/S004) | Ortho-Clinical Diagnostics, Inc. | 2012-11-13 |
| VITROS ANTI-HBS (P000014/S026) | Ortho-Clinical Diagnostics, Inc. | 2012-11-13 |
| BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S006) | Bio-Rad Laboratories, Inc. | 2012-11-13 |
| VITROS ANTI-HBC IGM (P030026/S026) | Ortho-Clinical Diagnostics, Inc. | 2012-11-13 |
| LEGOO (P110003/S003) | Genzyme Corp. | 2012-11-13 |
| BIO-RAD MONOLISA ANTI-HBS EIA (P050048/S008) | Bio-Rad Laboratories | 2012-11-13 |
| LEGOO ENDOVASCULAR OCCLUSION GEL (P110003/S002) | Genzyme Corp. | 2012-11-13 |
| UROVYSION BLADDER CANCER KIT (P030052/S010) | Abbott Molecular | 2012-11-13 |
| BARD ABLATION SYSTEM (P000020/S016) | Boston Scientific Corp | 2012-11-13 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S015) | Edwards Lifesciences, LLC | 2012-11-13 |
| VITROS ANTI-HCV (P010021/S023) | Ortho-Clinical Diagnostics, Inc. | 2012-11-13 |
| VITROS ANTI-HBE (P100001/S003) | Ortho-Clinical Diagnostics | 2012-11-13 |
| BIO-RAD MONOLISA ANTI-HBS EIA AND MONOLISA ANTI-HBS CALIBRATOR KIT (P050048/S007) | Bio-Rad Laboratories | 2012-11-13 |
| CAPENTIER-EDWARDS PERIMOUNT THEON, THEON PSR, MAGNA, MAGNA EASE, PERICARDIAL AORTIC BIOPROSTHESIS (P860057/S093) | Edwards Lifesciences, LLC | 2012-11-13 |
| BIO-RAD MONOLISA ANTI-HBC IGM EIA (P060034/S006) | Bio-Rad Laboratories, Inc. | 2012-11-13 |
| VITROS ANTI-HBC (P030024/S020) | Ortho-Clinical Diagnostics | 2012-11-13 |
| PROPEL MINI SINUS IMPLANT, 6011 (P100044/S003) | Intersect Ent. | 2012-11-09 |
| ALAIR BRONCHIAL THERMOPLASTY SYSTEM (P080032/S010) | Boston Scientific Corp | 2012-11-09 |
| SELUTE LEAD FAMILY (P950001/S024) | Boston Scientific | 2012-11-09 |
| CONTAK CD, LIVIAN, COGNIS FAMILIES OF CRT-DS; EASYTRAK, ACUITY SPRIAL FAMILIES OF LV PACING LEADS (P010012/S308) | Boston Scientific Corp | 2012-11-09 |
| ACUITY STEERABLE FAMILY OF LV PACING LEADS (P050046/S017) | Guidant Corp. | 2012-11-09 |
| ENDOTAK FAMILY OF ICD LEADS (P910073/S109) | Boston Scientific | 2012-11-09 |
| VENTAK AV, VENTAK PRIZM DR/VR, VITALITY, CONFIENT, LIVIAN, & TELIGEN FAMILIES OF ICDS (P960040/S276) | Boston Scientific | 2012-11-09 |
| SECONDLOOK DIGITAL V7.2 CAD (P010038/S016) | Icad, Inc. | 2012-11-09 |
| VENTAK PRIZM 2 FAMILIES, ICD (P890061/S021) | Boston Scientific | 2012-11-09 |
| CONTAK & RENEWAL TR FAMILY, CRT-P (P030005/S090) | Guidant Corp. | 2012-11-09 |
| EXPRESS LD ILLIAC PREMOUNTED STENT SYSTEM (P090003/S018) | Boston Scientific Corporation | 2012-11-09 |
| SWEET TIP RX, SWEET PICOTIP RX, FLEXTEND FAMILIES OF PACING LEADS (P960006/S036) | Boston Scientific | 2012-11-09 |
| DELTA, VISTA FAMILIES, PACEMAKER (P840068/S051) | Boston Scientific | 2012-11-09 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S097) | Cochlear Americas | 2012-11-09 |
| VENTAK PRX/VENTAK MINI FAMILIES OF ICDS (P910077/S126) | Boston Scientific | 2012-11-09 |
| RES-Q FAMILY OF ICD/ICD LEADS, RES-Q MICRON FAMILY OF ICDS (P940008/S030) | Boston Scientific | 2012-11-09 |
| LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (P000008/S029) | Medtimo, Inc. | 2012-11-09 |
| VIGOR DR/SR, DISCOVERY, MERIDIAN FAMILIES OF PACEMAKERS (P940031/S073) | Boston Scientific | 2012-11-09 |
| THERAKOS UVAR XTS INSTRUMENT, THERAKOS UVAR XTS PROCEDURAL KIT (125 ML), THERAKOS UVAR XTS PORCEDURAL KIT (225 ML), THEA (P860003/S066) | Therakos Development Limited | 2012-11-09 |
| VENTAK PRIZM 2 FAMILIES, ICD (P930035/S023) | Boston Scientific | 2012-11-09 |
| VENTAK , VENTAK PRIZM, ICD (P830060/S073) | Boston Scientific | 2012-11-09 |
| THINLINE/FINELINE FAMILIES OF PACING LEADS (P960004/S057) | Boston Scientific | 2012-11-09 |
| BD PREPSTAIN SYSTEM (P970018/S025) | Bd Diagnostic Systems | 2012-11-08 |
| RADIESSE INJECTABLE IMPLANT (P050037/S032) | Merz North America, Inc. | 2012-11-08 |
| GLAUKOS CORPORATION ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM (P080030/S002) | Glaukos Corporation | 2012-11-08 |
| RADIESSE INJECTABLE IMPLANT (P050052/S035) | Merz North America, Inc. | 2012-11-08 |
| EXTENDED WEAR SOFT CONTACT LENS (P830037/S054) | Alcon Laboratories, Inc. | 2012-11-08 |
| COOPERVISION METHAFILCON A SOFT EXTENDED WEAR CONTACT LENSES (P850079/S059) | CooperVision, Inc. | 2012-11-08 |
| FREQUENCY XCEL TONIC XR (P850079/S058) | CooperVision, Inc. | 2012-11-08 |
| IMMULITE PSA ASSAY (P930027/S015) | Siemens Healthcare Diagnostics, Inc. | 2012-11-08 |
| IMMULITE FPSA ASSAY (P060005/S008) | Siemens Medical Solutions Diagnostics Limited | 2012-11-08 |
| IMMULITE AFP ASSAY (P010007/S009) | Siemens Healthcare Diagnostics, Inc. | 2012-11-08 |
| CONTAK RENEWAL 3 CRT-DS, CONTAK RENEWAL 3 HE CRT-DS, LIVIAN CRT-DS, PUNCTUA CRT-DS (P010012/S307) | Boston Scientific Corp | 2012-11-07 |
| CONTAK RENEWAL TR CRT-PS, CONTAK RENEWAL TR 2 CRT-PS, INVIVE CRT-PS (P030005/S089) | Guidant Corp. | 2012-11-07 |
| ARCTIC FRONT CARDIAC CYROABLATION CATHETER, ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER (P100010/S020) | Medtronic Cryocath, LP | 2012-11-07 |
| MAXIMO II CRT-D, MAXIMO II ICD, MAXIMO II ICD, PROTECTA ICD AND PROTECTA XT ICD (P980016/S386) | Medtronic Cardiac Rhythm Disease Management | 2012-11-07 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S072) | W. L. Gore & Associates, Inc. | 2012-11-07 |
| GORE HELEX SEPTAL OCCLUDER, HX2015, HX2020, HX2025, HX2030, HX2035 (P050006/S032) | W. L. Gore & Associates, Inc. | 2012-11-07 |
| COGNIS, INCEPTA CRT-D, ENERGEN CRT-D, PUNCTUA CRT-D (P010012/S312) | Boston Scientific Corp | 2012-11-07 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (P110023/S004) | Medtronic Vascular, Inc. | 2012-11-07 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S047) | W. L. Gore & Associates, Inc. | 2012-11-07 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S034) | Boston Scientific Corp | 2012-11-07 |
| SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMS (P120002) | Cordis US Corporation | 2012-11-07 |
| ACUITY SPIRAL (P910073/S110) | Boston Scientific | 2012-11-07 |
| LATITUDE G2 COMMUNICATOR (P910077/S127) | Boston Scientific | 2012-11-07 |
| EXPRESS AND EXPRESS CORONARY STENT SYSTEMS (P020009/S093) | Boston Scientific Scimed, Inc. | 2012-11-07 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S051) | ABBOTT MEDICAL | 2012-11-07 |
| FRONTIER/FRONTIER II/ ANTHEM FAMILY OF CRT-P'S (P030035/S101) | ABBOTT MEDICAL | 2012-11-07 |
| PRIZM HE, VITALITY, VITALITY 2, CONFIENT, PUNCTUA, TELIGEN, ENERGEN, INCEPTA ICDS (P960040/S275) | Boston Scientific | 2012-11-07 |
| RELIANCE IS-1 (PASSIVE) DEFIBRILLATION LEAD (P010012/S309) | Boston Scientific Corp | 2012-11-07 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEMS (P040016/S098) | Boston Scientific Scimed, Inc. | 2012-11-07 |
| PUNCTUA ICD, TELIGEN, ENERGEN ICD, INCEPTA ICD (P960040/S279) | Boston Scientific | 2012-11-07 |
| PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEMS (P060001/S018) | Medtronic Vascular, Inc. | 2012-11-07 |
| AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S223) | ABBOTT MEDICAL | 2012-11-07 |
| CADENCE CURRENT FAMILY OF ICD'S (P910023/S302) | ABBOTT MEDICAL | 2012-11-07 |
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S082) | St. Jude Medical, Inc. | 2012-11-07 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S004) | Boston Scientific Corp | 2012-11-07 |
| EPIC HF/ ATLAS + HF PROMOTE FAMILY OF CRT-D'S (P030054/S230) | ABBOTT MEDICAL | 2012-11-07 |
| CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D. PROTECTA XT CRT-D (P010031/S338) | Medtronic Cardiac Rhythm Disease Management | 2012-11-07 |
| BREATHTEK UBT FOR H. PYLORI HIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE APPLICATION (PUHR-CA) (P100025/S003) | Meridian Bioscience, Inc. | 2012-11-06 |
| PROMETRA PROGRAMMABLE IMPLANTABLE PUMP, 1031200 (P080012/S009) | Infusyn Therapeutics, LLC | 2012-11-06 |
| RADIESSE INJECTABLE IMPLANT (P050052/S026) | Merz North America, Inc. | 2012-11-06 |
| RADIESSE INJECTABLE IMPLANT (P050037/S023) | Merz North America, Inc. | 2012-11-06 |
| COBAS HPV TEST (P100020/S007) | Roche Molecular Systems, Inc. | 2012-11-06 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S011) | Edwards Lifesciences, LLC | 2012-11-06 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S093) | Boston Scientific Scimed, Inc. | 2012-11-05 |
| INCEPTA, ENERGEN AND PUNCTUA CRT-D DEVICES (P010012/S311) | Boston Scientific Corp | 2012-11-05 |
| CRT-D MODELS: INCEPTA N160, N161, N164, ENERGEN N140, N141, PUNCTUA N050 (P010012/S310) | Boston Scientific Corp | 2012-11-05 |
| EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S031) | Boston Scientific Corp | 2012-11-05 |
| ICD MODELS, INCEPTA E-160, E-161, E162, E163, ENERGEN E140, E141, E142, E143, PUNCTUA E050, E050, E051, E052, E053 (P960040/S277) | Boston Scientific | 2012-11-05 |
| CARBOMEDICS PROSTHETIC HEART VALVE (P900060/S050) | Corcym S.r.l. | 2012-11-05 |
| ENDOTAK LEAD SYSTEM (P910073/S108) | Boston Scientific | 2012-11-05 |
| INCEPTA, ENERGEN AND PUNCTUA ICD DEVICES (P960040/S278) | Boston Scientific | 2012-11-05 |
| EXPRESS LD MONORAIL ILIAC PREMOUNTED STENT SYSTEM (P090003/S014) | Boston Scientific Corporation | 2012-11-05 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) (P110010/S031) | Boston Scientific Corp | 2012-11-05 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S093) | Boston Scientific Corp | 2012-11-05 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) (P100023/S056) | Boston Scientific Corp | 2012-11-05 |
| ZENITH TX2 TAA ENDOVASCULAR GRAFT (P070016/S005) | William Cook Europe Aps | 2012-11-05 |
| MEDTRONIC SELECTSECURE LEAD MODEL 3830 (P030036/S040) | Medtronic Cardiac Rhythm Disease Management | 2012-11-02 |
| CONCERTO II CRT-D,CONSULTA DF4 ICD,CONSULTA ICD,MAXIMO II CRT-D,MAXIMO II DF4 CRT-D,PROTECTA CRT-D,PROTECTA DF4 CRT-D (P010031/S336) | Medtronic Cardiac Rhythm Disease Management | 2012-11-02 |
| ELECSYS HBSAG IMMUNOASSAY, ELECSYS PRECICONTROL HBSAG AND ELECSYS HBSAG CONFIRMATORY TEST SYSTEM (P990012/S018) | Roche Diagnostics Corp. | 2012-11-02 |
| INTERSTIM II, 3058 (P970004/S144) | Medtronic Neuromodulation | 2012-11-02 |
| MAXIMO II DF4CRT-D,MAXIMO II DF4 ICD,MAXIMO II ICD,PROTECTA DF4 ICD,PROTECTA ICD,PROTECTA XT DF4 ICD,PROTECTA XT ICD (P980016/S384) | Medtronic Cardiac Rhythm Disease Management | 2012-11-02 |