| MICRONY FAMILY OF PACEMAKERS (P970013/S049) | ABBOTT MEDICAL | 2012-07-06 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S044) | Boston Scientific Corp | 2012-07-06 |
| MINILINK TRANSMITTER (MMT-7703), IPRO DIGITAL RECORDER (MMT-7709) AND IPRO2 RECORDER (MMT-7741) (P980022/S100) | Medtronic Minimed | 2012-07-06 |
| CVX-300 ANTI-REFLECTIVE WINDOW (P910001/S057) | Spectranetics Corp. | 2012-07-06 |
| EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S029) | Boston Scientific Corp | 2012-07-06 |
| EXPRESS 2 MONORAIL AND OVER-THE-WIRE (P020009/S086) | Boston Scientific Scimed, Inc. | 2012-07-06 |
| CADENCE/ ELLIPSE/ FORTIFY ASSURA FAMILY OF ICDS (P910023/S296) | ABBOTT MEDICAL | 2012-07-06 |
| CERVISTA HPV 16/18 (P080015/S008) | Hologic, Inc. | 2012-07-06 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (P110023/S003) | Medtronic Vascular, Inc. | 2012-07-06 |
| AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S219) | ABBOTT MEDICAL | 2012-07-06 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S089) | Boston Scientific Corp | 2012-07-06 |
| THERASCREEN KRAS RGQ PCR KIT (P110030) | QIAGEN Manchester, Ltd. | 2012-07-06 |
| SPOT-LIGHT HER2 CISH KIT (P050040/S003) | Invitrogen Corporation | 2012-07-06 |
| DERMAGRAFT (P000036/S012) | Shire Regenerative Medicine | 2012-07-05 |
| CAPSURE, CAPSURE MODEL (P890003/S250) | Medtronic, Inc. | 2012-07-05 |
| SELECTSECURE LEAD, MODEL 3830 (P030036/S043) | Medtronic Cardiac Rhythm Disease Management | 2012-07-05 |
| SPRINT QUATTRO (P920015/S092) | Medtronic, Inc. | 2012-07-05 |
| COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST) (P110037) | Roche Molecular Systems, Inc. | 2012-07-05 |
| DISPOSABLE FALOPE-RING BAND APPLICATOR KITS (P870076/S012) | Gyrus Acmi, Inc. | 2012-07-05 |
| CAPSURE Z NOVUS, CAPSURE SP NOVUS, CAPSURE SP Z, CAPSURE Z NOVUS, & IMPULSE II LEADS (P850089/S088) | Medtronic Cardiac Rhythm Disease Management | 2012-07-05 |
| CAPSUREFIX MRI LEAD (P090013/S064) | Medtronic, Inc. | 2012-07-05 |
| CAPSURE, VITATRON CRYSTALINE, & VITATRON EXCELLENCE PS+ (P830061/S076) | Medtronic Cardiac Rhythm Disease Management | 2012-07-05 |
| ADAPTA, ADAPTA L, ADAPTA S, SENSIA L, SENSIA, VERSA IPG (P980035/S273) | Medtronic, Inc. | 2012-07-05 |
| TRANSVENE LEAD, MODEL 6937A (P980050/S074) | Medtronic, Inc. | 2012-07-05 |
| THORATEC HEARTMATE II LVAS (P060040/S022) | ABBOTT MEDICAL | 2012-07-05 |
| CAPSUREFIX, CAPSUREFIX NOVUS, SUREFIX, & VITATRON CRYSTALLINE LEADS (P930039/S068) | Medtronic, Inc. | 2012-07-05 |
| SYNCARDIA COMPANION 2 DRIVER SYSTEM (P030011/S013) | Syncardia Systems, LLC | 2012-07-05 |
| SPECTRANETICS EXCIMER LASER (P910001/S056) | Spectranetics Corp. | 2012-07-03 |
| ABBOTT ARCHITECT HBSAG QUALITATIVE / ARCHITECT HBSAG QUALITATIVE CONFIRMATORY (P110029/S002) | Abbott Laboratories | 2012-07-03 |
| COOPERVISION BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES (P080011/S013) | CooperVision, Inc. | 2012-07-03 |
| INCEPTA, ENERGEN, PUNTUA IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P960040/S264) | Boston Scientific | 2012-07-03 |
| CERVISTA HUMAN PAPILLOMA VIRUS (HPV) (P080014/S013) | Hologic, Inc. | 2012-07-03 |
| ABBOTT ARCHITECT HBSAG/ ARCHITECT HBSAG CONFIRMATORY (P060007/S018) | Abbott Laboratories | 2012-07-03 |
| INCEPTA, ENERGEN, PUNCTUA (P010012/S294) | Boston Scientific Corp | 2012-07-03 |
| HEALON ENDOCOAT OPVISCOSURGICAL OPHTHALMIC DEVICE (OVD) (3% SODIUM HYALURONATE) (P110007) | Johnson & Johnson Surgical Vision, Inc. | 2012-07-02 |
| SPRINT QUATTRO SINGLE COIL DF4, ACTIVE FIXATION LEAD (P920015/S091) | Medtronic, Inc. | 2012-07-02 |
| TRIFECTA VALVE (P100029/S013) | ABBOTT MEDICAL | 2012-06-29 |
| DEXCOM SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM (P050012/S047) | Dexcom, Inc. | 2012-06-29 |
| COBAS AMPLIPREP / COBAS TAQMAN HBV TEST, V2.0 (P050028/S025) | Roche Molecular Systems, Inc. | 2012-06-29 |
| ETHICON OMNEX SURGICAL SEALANT (P060029/S004) | ETHICON, Inc. | 2012-06-29 |
| CARBOMEDICS PROSTHETIC HEART VALVE (P900060/S051) | Corcym S.r.l. | 2012-06-29 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S025) | Zoll Manufacturing Corporation | 2012-06-29 |
| PROTECTA XT/PROTECTA/CONSULTA/MAXIMO II CRT-D DF4 (P010031/S304) | Medtronic Cardiac Rhythm Disease Management | 2012-06-29 |
| COBAS AMPLIPREP / COBAS TAQMAN HCV TEST (P060030/S026) | Roche Molecular Systems, Inc. | 2012-06-29 |
| THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S049) | Thoratec Laboratories Corp. | 2012-06-29 |
| DURATA FAMILY OF HIGH VOLTAGE LEADS (P950022/S081) | ABBOTT MEDICAL | 2012-06-28 |
| MEDSTREAM PROGRAMMABLE INFUSION SYSTEM (P890055/S041) | Intera Oncology | 2012-06-28 |
| REFLECTION CERAMIC HIP SYSTEM (RCHS) (P030022/S021) | Smith & Nephew, Inc. | 2012-06-28 |
| COOPERVISION METHAFILCON A & B SOFT EXTENDED WEAR CONTACT LENSES (P850079/S052) | CooperVision, Inc. | 2012-06-28 |
| TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM (P000035/S007) | Nexus CMF, LLC | 2012-06-27 |
| INFUSE BONE GRAFT (P050053/S025) | Medtronic, Inc. | 2012-06-27 |
| TMJ FOSSA-EMINENCE & CONDYLAR PROSTHESIS SYSTEM (P000023/S007) | Nexus CMF, LLC | 2012-06-27 |
| ALAIR BRONCHIAL THERMOPLASTY SYSTEM (P080032/S009) | Boston Scientific Corp | 2012-06-26 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S012) | Syncardia Systems, LLC | 2012-06-26 |
| S.A.V. BIOPROSTHESIS MODEL 2650 (AORTIC) (P010041/S030) | Edwards Lifesciences, LLC | 2012-06-26 |
| ABIOMED BVS5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S052) | Abiomed Cardiovascular, Inc. | 2012-06-26 |
| RX HECULINK ELITE RENAL STENT SYSTEM (P110001/S003) | Abbott Vascular | 2012-06-26 |
| PROTECTA XT/PROTECTA/CONSULTA/MAXIMO II CRT-D ICDS (P010031/S311) | Medtronic Cardiac Rhythm Disease Management | 2012-06-25 |
| LIVIAN, PUNTUA CRT-D, COGNIS, ENERGEN CRT-D, INCEPTA CRT-D (P010012/S293) | Boston Scientific Corp | 2012-06-25 |
| VERSANT HCV RNA QUALITATIVE ASSAY (P020011/S005) | Gen-Probe | 2012-06-25 |
| MEDTRONIC OPEN PIVOT BILEAFLET HEART VALVED (P990046/S029) | Medtronic Ats Medical, Inc. | 2012-06-25 |
| INVIVE CRT-P CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKER (CRT-P) (P030005/S084) | Guidant Corp. | 2012-06-25 |
| GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L (P080030) | Glaukos Corporation | 2012-06-25 |
| MEDTRONIC DF4 PROTECTA XT/PROTECTA/SECURA/MAXIMO II VR/DR ICDS (P980016/S358) | Medtronic Cardiac Rhythm Disease Management | 2012-06-25 |
| MEDSTREAM PROGRAMMABLE INFUSION SYSTEM (P890055/S040) | Intera Oncology | 2012-06-25 |
| CONFIANT, PUNCTUA ICD, TELIGEN, ENERGEN ICD, INCEPTA ICD (P960040/S263) | Boston Scientific | 2012-06-25 |
| LINX REFLUX MANAGEMENT SYSTEM (P100049/S002) | Torax Medical | 2012-06-22 |
| CONTAK CD FAMILY (INCLUDES RENEWAL FAMILY) (P010012/S069) | Boston Scientific Corp | 2012-06-22 |
| AXXESS PERCUTANEOUS LEAD (P010032/S052) | ABBOTT MEDICAL | 2012-06-22 |
| ESTEEM (P090018/S016) | Envoy Medical Corporation | 2012-06-22 |
| VENTAK AV FAMILY (INCLUDES PRIZM AND VITALITY FAMILIES) (P960040/S078) | Boston Scientific | 2012-06-22 |
| THORATEC HEART MATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S018) | ABBOTT MEDICAL | 2012-06-22 |
| LINX REFLUX MANAGEMENT SYSTEM (P100049/S001) | Torax Medical | 2012-06-22 |
| SYNVISC AND SYNVISC-ONE (P940015/S026) | Sanofi Genzyme Corp. | 2012-06-22 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S033) | Zoll Manufacturing Corporation | 2012-06-22 |
| ACRYSOF RESTOR POSTERIOR CHAMBER LENS (P040020/S042) | Alcon Research, Ltd. | 2012-06-21 |
| ACCULINK, RX (P040012/S045) | Abbott Vascular | 2012-06-21 |
| XACT (P040038/S025) | Abbott Vascular, Inc. | 2012-06-21 |
| ABSOLUTE PRO, ABSOLUTE PRO LL (P110028/S003) | Abbott Vascular, Inc. | 2012-06-21 |
| HERCULINK ELITE, RX (P110001/S005) | Abbott Vascular | 2012-06-21 |
| PMMA MULTIPEICE POSTERIOR CHAMBER LENS (P810032/S061) | Alcon Laboratories | 2012-06-21 |
| ACRYSOF POSTERIOR CHAMBER LENS (P930014/S062) | Alcon Laboratories, Inc. | 2012-06-21 |
| RADIESSE INJECTABLE IMPLANT (P050052/S031) | Merz North America, Inc. | 2012-06-20 |
| ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (P110028/S002) | Abbott Vascular, Inc. | 2012-06-20 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S115) | Boston Scientific Corp | 2012-06-20 |
| VNS THERAPY SYSTEM (P970003/S149) | LivaNova USA, Inc. | 2012-06-20 |
| RADIESSE INJECTABLE IMPLANT (P050037/S028) | Merz North America, Inc. | 2012-06-20 |
| UNIFY QUADRA CRT-D, UNIFY QUADRA ASSURA (P030054/S222) | ABBOTT MEDICAL | 2012-06-20 |
| LIPOSORBER LA-15 SYSTEM (P910018/S016) | Kaneka Pharma America Corp. | 2012-06-19 |
| PUNCTUA CRT-D, ENERGEN CRT-D, INCEPTA CRT-D (P010012/S291) | Boston Scientific Corp | 2012-06-19 |
| VENTAK PRX AND VENTAK MINI AUTOMATIC IMPLANTABLE CARDIOVERTER (P910077/S121) | Boston Scientific | 2012-06-19 |
| PROTECTA CRT-D, PROTECTA DF4 CRT-D, PROTECTA XT CRT-D, PROTECTA XT DF4 CRT-D (P010031/S309) | Medtronic Cardiac Rhythm Disease Management | 2012-06-19 |
| PROTECTA DF4 ICD, PROTECTA ICD, PROTECTA XT DF4 ICD, PROTECTA XT ICD (P980016/S356) | Medtronic Cardiac Rhythm Disease Management | 2012-06-19 |
| GENESYS HTA SYSTEM (P000040/S024) | Axora Medical, Inc. | 2012-06-19 |
| COPPER VISION BIOFINITY (COMFILCON A) SOFT EXTENDED WEAR CONTACT LENSES (P080011/S012) | CooperVision, Inc. | 2012-06-19 |
| PUNCTUA ICD, ENEGEN ICD, INCEPTA ICD (P960040/S261) | Boston Scientific | 2012-06-19 |
| MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING (P980022/S103) | Medtronic Minimed | 2012-06-19 |
| MULTI-LINK 8 CORONARY STENT SYSTEM (P020047/S048) | Abbott Vascular | 2012-06-18 |
| ELECSYS ANTI-HBC-IGM ON COBAS E 411 (P110031/S001) | Roche Diagnostics Corp. | 2012-06-18 |
| CORONARY FLEXTOME CUTTING BALLOON (P950020/S050) | Boston Scientific Corp | 2012-06-18 |