| EDWARDS SAPIEN TRANSCATHER HEART VALVE, MODEL 9000TFX (P110021/S021) | Edwards Lifesciences, LLC | 2013-08-02 |
| DEEP BRAIN STIMULATION (DBS) INS ACTIVA FAMILY (P960009/S174) | Medtronic, Inc. | 2013-08-02 |
| ARISTA AH (P050038/S017) | Davol, Inc. | 2013-08-02 |
| SPINAL CORD STIMULATION (SCS) NEUROSTIMULATORS IMPLANTABLE (INS) RESTORE FAMILY (P840001/S243) | Medtronic Neuromodulation | 2013-08-02 |
| EDWARDS SAPIEN TRANSCATHETER HEART, MODEL 9000TFX (P100041/S035) | Edwards Lifesciences, LLC | 2013-08-02 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S096) | Cochlear Americas | 2013-08-02 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S028) | Medtronic | 2013-08-02 |
| ACTIVA PC,SC,AND RC IMPLANTABLE DEEP BRAIN STIMULATORS (P960009/S175) | Medtronic, Inc. | 2013-08-01 |
| PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S173) | Boston Scientific Corp | 2013-08-01 |
| REFLECTION CERAMIC HIP SYSTEM (P030022/S023) | Smith & Nephew, Inc. | 2013-08-01 |
| ABBOTT REAL TIME HCV GENOTYPE 11 (P120012/S001) | Abbott Molecular | 2013-08-01 |
| ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S012) | OraSure Technologies, Inc. | 2013-08-01 |
| INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S049) | Medtronic Sofamor Danek USA, Inc. | 2013-08-01 |
| INTERSTIM II IMPLANTABLE SACRAL NERVE STIMULATORS (P080025/S053) | Medtronic Neuromodulation | 2013-08-01 |
| INFUSE BONE GRAFT (P000054/S034) | Medtronic Sofamor Danek USA, Inc. | 2013-08-01 |
| INFUSE BONE GRAFT (P050053/S024) | Medtronic, Inc. | 2013-08-01 |
| SYNCHROMED II DRUG PUMP (P860004/S192) | Medtronic, Inc. | 2013-08-01 |
| INTERSTIM II IMPLANTABLE SACRAL NERVE STIMULATOR (P970004/S157) | Medtronic Neuromodulation | 2013-08-01 |
| VARIOUS MODELS OF THE ITREL 4, RESTORE, & SURE SCAN MRI FAMILIES OF IMPLANTABLE SPINAL CORD STIMULATORS (P840001/S244) | Medtronic Neuromodulation | 2013-08-01 |
| PROGEL PLEURAL AIR LEAK SEALANT (P010047/S031) | Neomend, Inc. | 2013-08-01 |
| MOSAIC PORCINE BIOPROSTHESIS (P990064/S049) | Medtronic, Inc. | 2013-07-31 |
| ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE (P060037/S023) | Zimmer, Inc. | 2013-07-31 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S041) | Medtronic, Inc. | 2013-07-31 |
| PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S174) | Boston Scientific Corp | 2013-07-31 |
| HANCOCK II BIOPROSTHETIC HEART VALVE (P980043/S041) | Medtronic, Inc. | 2013-07-31 |
| HANCOCK PORCINE BIOPROSTHESIS (P870078/S020) | Medtronic, Inc. | 2013-07-31 |
| HANCOCK MODIFIED ORIFICE VALVED CONDUIT (P790007/S037) | Medtronic Heart Valves | 2013-07-31 |
| INCEPTA,ENERGEN,PUNCTUA CRT-DS (P010012/S337) | Boston Scientific Corp | 2013-07-30 |
| OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVED GRAFT (P990046/S034) | Medtronic Ats Medical, Inc. | 2013-07-30 |
| LINOX S DX (P980023/S056) | Biotronik, Inc. | 2013-07-30 |
| INCEPTA,ENERGEN,PUNCTUA ICDS (P960040/S300) | Boston Scientific | 2013-07-30 |
| HANCOCK II BIOPROSTHETIC HEART VALVE (P980043/S043) | Medtronic, Inc. | 2013-07-30 |
| ECURO, EFFECTA, ESTELLA, EVIA ENTOVIS (P950037/S125) | Biotronik, Inc. | 2013-07-30 |
| THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER (P110016/S003) | ABBOTT MEDICAL | 2013-07-30 |
| BIOFINITY (P080011/S025) | CooperVision, Inc. | 2013-07-30 |
| HANCOCK MODIFIED ORIFICE VALVED CONDUIT (P790007/S039) | Medtronic Heart Valves | 2013-07-30 |
| ADVISA DR IPG, ADVISA DR MRI IPG (P980035/S337) | Medtronic, Inc. | 2013-07-30 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S078) | Medtronic, Inc. | 2013-07-30 |
| INCEPTA,ENERGEN,PUNCTUA CRTS (P010012/S335) | Boston Scientific Corp | 2013-07-30 |
| MOSAIC PORCINE BIOPROSTHESIS (P990064/S051) | Medtronic, Inc. | 2013-07-30 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P110013/S018) | Medtronic Vascular | 2013-07-30 |
| OXFORD PARTIAL KNEE (P010014/S044) | Biomet Manufacturing Corp | 2013-07-30 |
| INCEPTA,ENERGEN,PUNCTUA ICDS (P960040/S302) | Boston Scientific | 2013-07-30 |
| HANCOCK PORCINE BIOPROSTHESIS (P870078/S022) | Medtronic, Inc. | 2013-07-30 |
| SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES(OVD), HEALON, HEALON GV AND HEALON5 PRODUCTS (P810031/S049) | Johnson & Johnson Surgical Vision, Inc. | 2013-07-30 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S207) | Medtronic, Inc. | 2013-07-30 |
| LLESTO, IFORIA, LUMAX, (P050023/S067) | Biotronik, Inc. | 2013-07-30 |
| REVO MRI IPG. (P090013/S106) | Medtronic, Inc. | 2013-07-30 |
| LUMAX (P050023/S066) | Biotronik, Inc. | 2013-07-30 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S043) | Medtronic, Inc. | 2013-07-30 |
| ENTOVIS HF(-T), EVIA HF (-T) (P070008/S044) | Biotronik, Inc. | 2013-07-30 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS)SYSTEM (P030017/S172) | Boston Scientific Corp | 2013-07-30 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM (P110010/S056) | Boston Scientific Corp | 2013-07-28 |
| ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S075) | Boston Scientific Corp | 2013-07-28 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM,XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM,XIENCE XP (P110019/S045) | Abbott Vascular | 2013-07-26 |
| ARCTIC FRONT AND ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHERTERS (P100010/S030) | Medtronic Cryocath, LP | 2013-07-26 |
| INTEGRITY CORONARY STENT SYSTEMS (P030009/S065) | Medtronic, Ireland | 2013-07-26 |
| AMPLATZER DUCT OCCLUDER (P020024/S039) | ABBOTT MEDICAL | 2013-07-26 |
| ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM (P110011/S003) | Medtronic, Ireland | 2013-07-26 |
| EVERA S DR ICD, EVERA S VR ICD EVERA XT DR ICD, EVERA XT VR ICD (P980016/S424) | Medtronic Cardiac Rhythm Disease Management | 2013-07-26 |
| MAXIMO II ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S423) | Medtronic Cardiac Rhythm Disease Management | 2013-07-26 |
| AMPLATZER SEPTAL OCCLUDER AND AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER-CRIBRIFORM (P000039/S049) | ABBOTT MEDICAL | 2013-07-26 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S019) | Medtronic Vascular | 2013-07-26 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S079) | Medtronic, Inc. | 2013-07-26 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S385) | Medtronic Cardiac Rhythm Disease Management | 2013-07-26 |
| MEDTRONIC OPEN PIVOT HEART VALVE (P990046/S033) | Medtronic Ats Medical, Inc. | 2013-07-26 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S023) | ABBOTT MEDICAL | 2013-07-26 |
| CONCERTO II CRT-D, CONSULTA ICD, MAXIMO CRT-D (P010031/S384) | Medtronic Cardiac Rhythm Disease Management | 2013-07-26 |
| CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060/S052) | Corcym S.r.l. | 2013-07-25 |
| IOL DELIVERY SYSTEM (P090022/S017) | Lenstec, Inc. | 2013-07-25 |
| PROGEL PLEURAL AIR LEAK SEALANT (P010047/S026) | Neomend, Inc. | 2013-07-25 |
| ADVANTIO, INGENIO, VITALIO, AND FORMIO (N970003/S152) | Boston Scientific Corp | 2013-07-25 |
| INVIVE,INTUA CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKERS (CRT-P) (P030005/S099) | Guidant Corp. | 2013-07-25 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S027) | Medtronic | 2013-07-25 |
| PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY (P020055/S008) | Ventana Medical Systems, Inc. | 2013-07-25 |
| INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (P100027/S009) | Ventana Medical Systems, Inc. | 2013-07-25 |
| SUPARTZ (P980044/S016) | Seikagaku Corp. | 2013-07-25 |
| PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S019) | Ventana Medical Systems, Inc. | 2013-07-25 |
| EPIC VASCULAR STENT SYSTEM (P110035/S017) | Boston Scientific Corp | 2013-07-24 |
| AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT PRODUCT (P800002/S019) | C.R. Bard, Inc. | 2013-07-24 |
| COGNIS, INCEPTA CRT-D , ENERGEN CRT-D PUNCTUA CRT-D (P010012/S334) | Boston Scientific Corp | 2013-07-24 |
| TELIGEN,INCEPTA,ENERGEN,PUNCTUA ICDS (P960040/S298) | Boston Scientific | 2013-07-24 |
| VISCOAT OPTHALMIC VISCOSURGICAL DEVICE; DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE (P840064/S054) | Alcon Laboratories | 2013-07-24 |
| COGNIS,INCEPTA,ENERGEN,PUNCTUA CRT-DS (P010012/S333) | Boston Scientific Corp | 2013-07-24 |
| AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT PRODUCT (N17600/S028) | Davol Inc., Sub. C. R. Bard, Inc. | 2013-07-24 |
| TELIGEN, INCEPTA ICD, ENERGEN ICD, PUNCTUA ICD (P960040/S299) | Boston Scientific | 2013-07-24 |
| CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, SUREFIX LEAD, TORQUE CLIP DEVICE-ACCESSORY FOR 5076 LEAD (P930039/S089) | Medtronic, Inc. | 2013-07-23 |
| SELECTSECURE LEAD (P030036/S058) | Medtronic Cardiac Rhythm Disease Management | 2013-07-23 |
| ACRYSOF INTRAOCULAR LENSES (IOLS) (P930014/S066) | Alcon Laboratories, Inc. | 2013-07-23 |
| BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICDM INSYNC III MARQUIS (P010031/S377) | Medtronic Cardiac Rhythm Disease Management | 2013-07-23 |
| ZILVER PTX DRUG ELUTING PERIPHERAL STENT (P100022/S007) | Cook Ireland, Ltd. | 2013-07-23 |
| ATTAIN STARFIX LEAD (P060039/S047) | Medtronic, Inc. | 2013-07-23 |
| ATTAIN BIPOLAR OTW LEAD, CONSULTA CRT-P, LEFT VENTRICULAR PACING LEAD (P010015/S202) | Medtronic, Inc. | 2013-07-23 |
| CAPSUREFIX MRI LEAD, REVO MRI IPG (P090013/S099) | Medtronic, Inc. | 2013-07-23 |
| TRANSVENE LEAD (P980050/S084) | Medtronic, Inc. | 2013-07-23 |
| PMMA MULTI-PIECE POSTERIOR CHAMBER IOLS (P810032/S063) | Alcon Laboratories | 2013-07-23 |
| ACE HEADER, END CAP, SIZING SLEEVE, , UPSIZING SLEEVE (P900061/S122) | Medtronic Cardiac Rhythm Disease Management | 2013-07-23 |
| EVERA S DR ICD, S VR ICD,XT DR ICD, XT VR ICD, INTRINISIC ICD, MARQUIS DR ICD, VR ICD, MAXIMO DR ICD, MAXIMO II ICD; VR (P980016/S417) | Medtronic Cardiac Rhythm Disease Management | 2013-07-23 |
| CAPSURE LEAD, PRODIGY IPG, SERVICE KIT-PACEMAKER REPAIR KIT (P890003/S278) | Medtronic, Inc. | 2013-07-23 |
| INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (P100027/S007) | Ventana Medical Systems, Inc. | 2013-07-23 |