| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S004) | Boston Scientific Corporation | 2013-02-21 |
| WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM (P020050/S009) | Alcon Laboratories, Inc. | 2013-02-21 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S003) | Boston Scientific Corporation | 2013-02-21 |
| TITAN INFLATABLE PENILE PROSTHESIS (P000006/S032) | Coloplast Corp. | 2013-02-21 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S046) | Boston Scientific Corp | 2013-02-21 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S047) | Boston Scientific Corp | 2013-02-21 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (RX & OTW), XIENCE NANO EECSS (RX) (P070015/S106) | Abbott Vascular, Inc. | 2013-02-20 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S041) | Boston Scientific Corp | 2013-02-20 |
| ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS MOBILE BEARING KNEE SYSTEM (P060037/S019) | Zimmer, Inc. | 2013-02-20 |
| IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD) (P960040/S286) | Boston Scientific | 2013-02-20 |
| CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATORS (CRT-D) (P010012/S321) | Boston Scientific Corp | 2013-02-20 |
| NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS (P040046) | Allergan | 2013-02-20 |
| IPRO2 CGM RECORDER (P980022/S127) | Medtronic Minimed | 2013-02-20 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S007) | Boston Scientific Corp | 2013-02-20 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S108) | Boston Scientific Scimed, Inc. | 2013-02-20 |
| XIENCE PRIME/ XIENCE PRIME LL / XIENCE EXPEDITION/ XIENCE EXPEDITION SV AND LL EVEROLIMUS ELUTING CORONARY STENT SYTEM (P110019/S040) | Abbott Vascular | 2013-02-20 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S006) | Boston Scientific Corp | 2013-02-20 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S162) | Medtronic, Inc. | 2013-02-19 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S015) | Medtronic | 2013-02-19 |
| COROX OTW 85 UP STEROID, LUMAX 300 DR-T, LUMAX 340 DR-T,LUMAX 300 VR-T, LUMAX 340 VR-T, LUMAX 500 DR-T,LUMAX 540 DR-T, L (P050023/S060) | Biotronik, Inc. | 2013-02-19 |
| ENRHYTHM IPG (P980035/S270) | Medtronic, Inc. | 2013-02-19 |
| REVO MRI IPG, ENRHYTHM MRI IPG (P090013/S063) | Medtronic, Inc. | 2013-02-19 |
| THERAKOS CELLEX PHOTOPHERESIS SYSTEM (P860003/S070) | Therakos Development Limited | 2013-02-19 |
| LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER (EPTC) EXT CBL, SAFIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, EXT CBL, S (P960016/S040) | St Jude Medical | 2013-02-19 |
| SJM MASTERS HP VALVED GRAFT (P810002/S080) | ABBOTT MEDICAL | 2013-02-19 |
| ARTEFILL (P020012/S007) | Tiger Aesthetics Medical, LLC | 2013-02-19 |
| KAINOX VCS,SLX 58/11-BP,SLX 58/13-BP,SLX 58/14-BP,SLX 58/15-BP,SLX 58/17-BP,LINOX S 65,LINOX S 75, LINOX T 65,LINOX T75, (P980023/S051) | Biotronik, Inc. | 2013-02-19 |
| DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S011) | DePuy Orthopaedics, Inc. | 2013-02-19 |
| STRATOS LV,EVIA HF,EVIA HF-T,ENTOVIS HF,ENTOVIS HF-T,COROX OTW 85 UP STEROID,COROX OTW 75-BP,COROX OTW 85-BP,COROX OTW-S (P070008/S038) | Biotronik, Inc. | 2013-02-19 |
| EVIA DR, EVIA DR-T,EVIA SR, EVIA SR-T,ENTOVIS DR, ENTOVIS DR-T,ENTOVIS SR,ENTOVIS SR-T,ESTELLA SR,ESTELLA SR-T,ECURO DR, (P950037/S118) | Biotronik, Inc. | 2013-02-19 |
| ZILVER PTX DRUG-ELUTING PERIPHERAL STENT (P100022/S003) | Cook Ireland, Ltd. | 2013-02-15 |
| THERAKOS CELLEX / THERAKOS UVAR XTS PHOTOPHERESIS SYSTEMS (P860003/S069) | Therakos Development Limited | 2013-02-15 |
| QUADRIPOLAR PACING PAS (QUAD PAS) (P030054/S236) | ABBOTT MEDICAL | 2013-02-15 |
| SNS URINARY NEUROSTIMULATOR IMPLANTABLE INTERSTIM FAMILY (P970004/S148) | Medtronic Neuromodulation | 2013-02-14 |
| TITAN INFLATABLE PENILE PROSTHESIS (P000006/S031) | Coloplast Corp. | 2013-02-14 |
| AORFIX FLEXIBLE STENT GRAFT SYSTEM (P110032) | Lombard Medical Limited | 2013-02-14 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM (P110010/S045) | Boston Scientific Corp | 2013-02-14 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.0 (P060030/S027) | Roche Molecular Systems, Inc. | 2013-02-14 |
| INTERSTIM NEUROSTIULATOR (P970004/S149) | Medtronic Neuromodulation | 2013-02-14 |
| SNS BOWEL NEUROSTIMULATOR IMPLANTABLE INTERSTIM FAMILY (P080025/S044) | Medtronic Neuromodulation | 2013-02-14 |
| WALLSTENT (VENOUS) ENDOPROSTHESIS (P980033/S030) | Boston Scientific Corporation | 2013-02-14 |
| INTERSTIM NEUROSTIMULATOR (P080025/S045) | Medtronic Neuromodulation | 2013-02-14 |
| EXPRESS CORONARY STENT SYSTEM (P020009/S102) | Boston Scientific Scimed, Inc. | 2013-02-14 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S068) | Boston Scientific Corp | 2013-02-14 |
| ACTIVA SC NEUROSTIMULATOR, SOLETRA NEUROSTIMULATOR, KINETRA NEUROSTIMULATOR (P960009/S162) | Medtronic, Inc. | 2013-02-14 |
| WALLSTENT (TIPS) ENDOPROSTHESIS (P930031/S041) | Boston Scientific Corp | 2013-02-14 |
| OXFORD PARTIAL KNEE SYSTEM-TIBIAL TRAYS (P010014/S041) | Biomet Manufacturing Corp | 2013-02-14 |
| ITREL 4 NEUROSTIMULATOR, ITREL 3 NEUROSTIMULATOR, SYNERGY NEUROSTIMULATOR, SYNERGY VERSITREL NEUROSTIMULATOR (P840001/S232) | Medtronic Neuromodulation | 2013-02-14 |
| ENDOTAK RELIANCE, ENDOTAK RELIANCE 4-SITE (P910073/S115) | Boston Scientific | 2013-02-14 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S120) | Boston Scientific Corp | 2013-02-14 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S107) | Boston Scientific Scimed, Inc. | 2013-02-14 |
| PERIMOUNT PERICARDIAL AORTIC AND MITRAL BIOPROSTHESIS (P860057/S103) | Edwards Lifesciences, LLC | 2013-02-14 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S040) | Boston Scientific Corp | 2013-02-14 |
| BELOTERO BALANCE (P090016/S005) | Merz North America, Inc. | 2013-02-14 |
| LINOX(SMART) S DX STEROID-ELUTING SINGLE-COIL ICD LEADS (P980023/S049) | Biotronik, Inc. | 2013-02-13 |
| ON-X PROSTHETIC HEART VALVE (P000037/S028) | On-X Life Technologies, Inc. | 2013-02-13 |
| INFUSE BONE GRAFT (P050053/S029) | Medtronic, Inc. | 2013-02-13 |
| INFUSE BONE GRAFT (P000054/S037) | Medtronic Sofamor Danek USA, Inc. | 2013-02-13 |
| MODEL 5019 HIGH VOLTAGE (HV) SPLITTER/ADAPTOR KIT (P920015/S093) | Medtronic, Inc. | 2013-02-13 |
| INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S052) | Medtronic Sofamor Danek USA, Inc. | 2013-02-13 |
| PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM (P080012/S004) | Infusyn Therapeutics, LLC | 2013-02-13 |
| EVIA HF,EVIA HF-T, ENTOVIS HF, ENTOVIS HF-T (P070008/S035) | Biotronik, Inc. | 2013-02-12 |
| LUMAX FAMILY OF ICD AND CRT-D (P050023/S057) | Biotronik, Inc. | 2013-02-12 |
| CORONARY FLEXTONE CUTTING BALLOON (P950020/S060) | Boston Scientific Corp | 2013-02-12 |
| PROTEGE RX CAROTID STENT SYSTEM (P060001/S017) | Medtronic Vascular, Inc. | 2013-02-12 |
| ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (P110028/S007) | Abbott Vascular, Inc. | 2013-02-12 |
| EVIA/ENTOVIS/ECURO/EFFECTA/ESTELLA PULSE GENERATORS (P950037/S113) | Biotronik, Inc. | 2013-02-12 |
| MULTIPLE APPLICATION UTILITY (MAU) USED WITH ZOOM LATITIDE PROGRAMMING SYSTEM (P910077/S130) | Boston Scientific | 2013-02-12 |
| MEDSTREAM PROGRAMMABLE INFUSION SYSTEM (P890055/S031) | Intera Oncology | 2013-02-12 |
| MEDTRONIC MINIMED CONTINUOUS SUBCUTANEOUS GLUCOSE MONITORING SYSTEM (P980022/S128) | Medtronic Minimed | 2013-02-11 |
| COBAS AMPLIPREP / COBAS TAQMAN HCV TEST (P060030/S031) | Roche Molecular Systems, Inc. | 2013-02-11 |
| COBAS AMPLIPREP / COBAS TAQMAN CMV TEST (P110037/S004) | Roche Molecular Systems, Inc. | 2013-02-11 |
| COBAS AMPLIPREP / COBAS TAQMAN HBV TEST, V2.0 (P050028/S029) | Roche Molecular Systems, Inc. | 2013-02-11 |
| PARADIGM REAL-TIME PUMP, PARADIGM REAL TIME REVEL INSULIN PUMP (P980022/S129) | Medtronic Minimed | 2013-02-11 |
| PATHVYSION HER-2 DNA PROBE KIT (P980024/S010) | Abbott Molecular, Inc. | 2013-02-10 |
| UROVYSION BLADDER CANCER KIT (P030052/S011) | Abbott Molecular | 2013-02-10 |
| BIOMET EBI BONE HEALING SYSTEM (P790002/S028) | Ahp Eos Buyer, Inc. | 2013-02-08 |
| ICD PUNCTUA VR IS4 (P960040/S285) | Boston Scientific | 2013-02-08 |
| CARELINK MONITOR MODEL 2490G, CARDIOSIGHT READER MODEL 2020A, AND MODEL 2491 DDMA (P890003/S262) | Medtronic, Inc. | 2013-02-08 |
| ADVISA DR MRI A2DR01 IMPLANTABLE PULSE GENERATOR SOFTWARE MODEL 9995 (P980035/S294) | Medtronic, Inc. | 2013-02-08 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES (P110021/S007) | Edwards Lifesciences, LLC | 2013-02-08 |
| ENERGEN CRT-D IS4 (P010012/S320) | Boston Scientific Corp | 2013-02-08 |
| SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES (P100041/S021) | Edwards Lifesciences, LLC | 2013-02-08 |
| REVO MRI IPG (P090013/S083) | Medtronic, Inc. | 2013-02-07 |
| ADAPTA/VERSA/SENSIA IPG (P980035/S303) | Medtronic, Inc. | 2013-02-07 |
| INFUSE BONE GRAFT (P050053/S028) | Medtronic, Inc. | 2013-02-07 |
| CAPSURE SENSE BIPOLAR LEAD (P830061/S085) | Medtronic Cardiac Rhythm Disease Management | 2013-02-07 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S187) | Medtronic, Inc. | 2013-02-07 |
| VNS THERAPY PULSE GENERATOR (DEMIPULSE AND DEMIPULSE DUO) (P970003/S156) | LivaNova USA, Inc. | 2013-02-07 |
| INFUSE BONE GRAFT (P000054/S036) | Medtronic Sofamor Danek USA, Inc. | 2013-02-07 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, RELIA IPG (P980035/S304) | Medtronic, Inc. | 2013-02-07 |
| CAPSUREFIX MRI SURESCAN LEAD (P090013/S082) | Medtronic, Inc. | 2013-02-07 |
| ABBOTT REALTIME HBV (P080026/S005) | Abbott Molecular, Inc. | 2013-02-07 |
| CAPSUREFIX NOVUS LEAD (P930039/S082) | Medtronic, Inc. | 2013-02-07 |
| MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S395) | Medtronic Cardiac Rhythm Disease Management | 2013-02-07 |
| CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S345) | Medtronic Cardiac Rhythm Disease Management | 2013-02-07 |
| EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S015) | Exactech, Inc. | 2013-02-07 |
| INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S051) | Medtronic Sofamor Danek USA, Inc. | 2013-02-07 |
| ACCESS HYBRITECH PSA REAGENTS ON THE IMMUNOASSAY SYSTEMS (P850048/S031) | Beckman Coulter, Inc. | 2013-02-06 |
| AMS 800 ARTIFICIAL URINARY SPHINCTER (AUS) (P000053/S047) | Boston Scientific Corp | 2013-02-06 |