| Y ADAPTOR /EXTENDER KIT, DF-1 CONNECTOR PORT PIN PLUG, IS-1 CONNECTOR PORT PIN PLUG KIT, LEAD ADAPTOR, SPRINT QUATTRO (P920015/S100) | Medtronic, Inc. | 2012-12-20 |
| SYNCHROMED (P860004/S179) | Medtronic, Inc. | 2012-12-20 |
| PRECICONTROL ANTI-HBC IGM (COBAS E 601) (P110022/S009) | Roche Diagnostics Corp. | 2012-12-20 |
| ESSURE SYSTEM (P020014/S039) | Bayer Pharma AG | 2012-12-20 |
| PATH VYSION HER-2 DNA PROBE KIT ASSAY (P980024/S007) | Abbott Molecular, Inc. | 2012-12-20 |
| MOSAIC PORCINE BIOPROSTHESIS (P990064/S044) | Medtronic, Inc. | 2012-12-19 |
| SELECTSECURE LEAD (P030036/S051) | Medtronic Cardiac Rhythm Disease Management | 2012-12-19 |
| SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD (P920015/S098) | Medtronic, Inc. | 2012-12-19 |
| HANCOCK II BIOPROSTHETIC HEART VALVE (P980043/S036) | Medtronic, Inc. | 2012-12-19 |
| HANCOCK PORCINE BIOPROSTHESIS (P870078/S017) | Medtronic, Inc. | 2012-12-19 |
| SOLESTA (P100014/S008) | Palette Life Sciences | 2012-12-19 |
| RX ACCULINK CAROTID STENT SYSTEM (P040012/S050) | Abbott Vascular | 2012-12-19 |
| HANCOCK MODIFIED ORIFICE VALVED CONDUIT (P790007/S033) | Medtronic Heart Valves | 2012-12-19 |
| MERLIN NET 6.1M (P030054/S237) | ABBOTT MEDICAL | 2012-12-19 |
| EVIA DR, EVIA SR, ENTOVIS DR, ENTOVIS SR, ESTELLA DR, ESTELLA SR, EFFECTA D, EFFECTA DR, EFFECTA S, EFFECTA SR, ECURO DR (P950037/S114) | Biotronik, Inc. | 2012-12-19 |
| AMPLATZER SEPTAL OCCLUDER (P000039/S047) | ABBOTT MEDICAL | 2012-12-19 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S041) | Boston Scientific Corp | 2012-12-19 |
| SPRINT QUATTRO LEADS (P920015/S099) | Medtronic, Inc. | 2012-12-19 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S037) | Medtronic, Inc. | 2012-12-19 |
| MERLIN HOME 6.1M (P910023/S307) | ABBOTT MEDICAL | 2012-12-19 |
| INTACS CORNEAL IMPLANTS (P980031/S011) | Addition Technology | 2012-12-19 |
| DEFLUX INJECTABLE GEL (P000029/S073) | Palette Life Sciences | 2012-12-19 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S006) | Medtronic | 2012-12-19 |
| WALLSTENT (TIPS) ENDOPROSTHESIS (P930031/S038) | Boston Scientific Corp | 2012-12-18 |
| VIFILCON A SOFT CONTACT LENSES FOR EXTENDED WEAR (P820021/S035) | Alcon Laboratories, Inc. | 2012-12-18 |
| PEARL 8.0 HANDPIECE FOR TRANSMYOCARDIAL REVASCULARIZATION (TMR) WITH THE CARDIOGENESIS HOLMIUM: YAG LASER SYSTEM (P970029/S022) | Cryolife, Inc. | 2012-12-18 |
| RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM (P110038/S001) | Bolton Medical, Inc. | 2012-12-18 |
| HEARTWARE VENTRICULAR ASSISTE SYSTEM (P100047/S009) | Medtronic | 2012-12-18 |
| ELECSYS TOTAL PSA (P990056/S016) | Roche Diagnostics Corp. | 2012-12-18 |
| ELECSYS FREE PSA (P000027/S014) | Roche Diagnostics Corp. | 2012-12-18 |
| WALLSTENT (ILIAC) ENDOPROSTHESIS (P940019/S033) | Boston Scientific Scimed, Inc. | 2012-12-18 |
| COOPERVISION COMFILCON A SOFT EXTENDED WEAR CONTACT LENSES (P080011/S015) | CooperVision, Inc. | 2012-12-18 |
| RELIANCE IS-1/IS-4 ACTIVE AND PASSIVE FIXATION DEFIBRILATION LEADS (P910073/S114) | Boston Scientific | 2012-12-18 |
| WALLSTENT (VENOUS) ENDOPROSTHESIS (P980033/S027) | Boston Scientific Corporation | 2012-12-18 |
| ACTIVA PC, ACTIVA SC, ACTIVA RC, KINETRA, SOLETRA (P960009/S160) | Medtronic, Inc. | 2012-12-17 |
| SYNCHROMED INFUSION SYSTEMS, SYNCHROMED, SYNCHROMED II, SYNCHROMED EL (P860004/S177) | Medtronic, Inc. | 2012-12-17 |
| ITREL 3, ITREL 4, SYNERGY, SYNERGY VERSITREL, RESTORE, RESTOREPRIME, ADVANCEDRESTORE, ULTRA, ENS (P840001/S230) | Medtronic Neuromodulation | 2012-12-17 |
| CURRENT FAMILY OF ICDS (P910023/S310) | ABBOTT MEDICAL | 2012-12-17 |
| ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S007) | OraSure Technologies, Inc. | 2012-12-17 |
| CHILLI II COOL ABLATION CATHETER (P980003/S037) | Boston Scientific Corp | 2012-12-17 |
| PROMOTE FAMILY OF CRT-DS (P030054/S239) | ABBOTT MEDICAL | 2012-12-17 |
| ARCHITECT AUSAB (P050051/S019) | Abbott Laboratories, Inc. | 2012-12-14 |
| CERVISTA HPV HR (P080014/S014) | Hologic, Inc. | 2012-12-14 |
| ARCHITECT CORE-M (P060035/S018) | Abbott Laboratories | 2012-12-14 |
| DEXCOM SEVEN PLUS SYSTEM (P050012/S046) | Dexcom, Inc. | 2012-12-14 |
| ARCHITECT HBSAG/CONFIRMATORY (P060007/S025) | Abbott Laboratories | 2012-12-14 |
| ARCHITECT CORE (P080023/S019) | Abbott Laboratories | 2012-12-14 |
| ARCHITECT ANTI-HCV (P050042/S021) | Abbott Laboratories, Inc. | 2012-12-14 |
| ARCHITECT HBSAG QUALITTATIVE/CONFIRMATORY (P110029/S010) | Abbott Laboratories | 2012-12-14 |
| ION (TAXUS ELEMENT) PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S064) | Boston Scientific Corp | 2012-12-13 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S077) | W. L. Gore & Associates, Inc. | 2012-12-13 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S104) | Boston Scientific Scimed, Inc. | 2012-12-13 |
| EXCOSEAL VASCULAR CLOSURE DEVICE (P100013/S007) | Cordis US Corporation | 2012-12-13 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S037) | Boston Scientific Corp | 2012-12-13 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S039) | Boston Scientific Corp | 2012-12-13 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S099) | Boston Scientific Scimed, Inc. | 2012-12-13 |
| CORONARY FLEXTOME CUTTING BALLON (P950020/S058) | Boston Scientific Corp | 2012-12-13 |
| ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT (P020018/S044) | Cook, Inc. | 2012-12-12 |
| NIDEK EC-5000 EXCIMER LASER SYSTEM (P970053/S012) | Nidek Co., Ltd. | 2012-12-12 |
| RELIANCE DF4 LEADS (P910073/S113) | Boston Scientific | 2012-12-12 |
| ADVISA DR IPG (P980035/S300) | Medtronic, Inc. | 2012-12-12 |
| MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD AND VIRTUOSO II DR/VR ICD (P980016/S388) | Medtronic Cardiac Rhythm Disease Management | 2012-12-12 |
| GEM II VR ICD,MARQUIS VR ICD,GEM III VR ICD,MAXIMO VR ICD,GEM DR ICD,GEM II DR ICD,MARQUIS DR ICD,GEM III DR ICD (P980016/S390) | Medtronic Cardiac Rhythm Disease Management | 2012-12-12 |
| VISCOAT AND DUOVISC OPHTHALMIC VISCOSURGICAL DEVICES (OVD) (P840064/S052) | Alcon Laboratories | 2012-12-12 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S183) | Medtronic, Inc. | 2012-12-12 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S182) | Medtronic, Inc. | 2012-12-12 |
| ADVISA DR IPG (P980035/S298) | Medtronic, Inc. | 2012-12-12 |
| ZENITH AAA ENDOVASCULAR GRAFT (P020018/S047) | Cook, Inc. | 2012-12-12 |
| CONCERTO II CRT-D, CONSULTA DF4-ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D AND PROTECTA XT CRT-D (P010031/S340) | Medtronic Cardiac Rhythm Disease Management | 2012-12-12 |
| JEWEL ICD, JEWEL PLUS ICD, MICRO JEWEL ICD, MICRO JEWEL II ICD, GEM ICD (P900061/S117) | Medtronic Cardiac Rhythm Disease Management | 2012-12-12 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM (P110010/S038) | Boston Scientific Corp | 2012-12-11 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM (P110010/S040) | Boston Scientific Corp | 2012-12-11 |
| VERIFLEX (LIBERTE) BARE METAL CORONARY STENT SYSTEM (P040016/S105) | Boston Scientific Scimed, Inc. | 2012-12-11 |
| REPLY/ESPRIT PACEMAKERS (P950029/S072) | MicroPort CRM USA, Inc. | 2012-12-11 |
| FLEXTOME CUTTING BALLOON DILATATION DEVICE (P950020/S059) | Boston Scientific Corp | 2012-12-11 |
| WALLSTENT ILIAC ENDOPROSTHESIS (P940019/S034) | Boston Scientific Scimed, Inc. | 2012-12-11 |
| VERIFLEX MONORAIL & OVER-THE-WIRE CORONARY STENT SYSTEM (P040016/S103) | Boston Scientific Scimed, Inc. | 2012-12-11 |
| ADAPTA, ADAPTA L, ADAPTA S, SENSIA L, SENSIA, VERSA IPG (P980035/S296) | Medtronic, Inc. | 2012-12-11 |
| CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S012) | Boston Scientific Corp | 2012-12-11 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS,CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL (P870077/S049) | Edwards Lifesciences, LLC | 2012-12-11 |
| ARCHITECT FREE PSA AND AXSYM FREE PSA (P980007/S027) | Abbott Laboratories | 2012-12-11 |
| TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S099) | Boston Scientific Corp | 2012-12-11 |
| CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, MAXIMO II DF4 CRT-D, PROTECTA CRT-D, PROTECTA DF4 CR (P010031/S341) | Medtronic Cardiac Rhythm Disease Management | 2012-12-11 |
| VISTAKON (ETAFILCON A) BRAND CONTACT LENSES (N18033/S067) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2012-12-11 |
| TAXUS LIBERTE MONORAIL AND AND OVER-THE-WIRE CORONARY STENT SYSTEM (P060008/S100) | Boston Scientific Corp | 2012-12-11 |
| COGNIS CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR, INCEPTA CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR, ENERGEN (P010012/S316) | Boston Scientific Corp | 2012-12-11 |
| CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS (P010041/S038) | Edwards Lifesciences, LLC | 2012-12-11 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES, RETROFLEX 3 DELIVERY SYSTEM,RETROFLEX BALLOON CATHETER (P110021/S002) | Edwards Lifesciences, LLC | 2012-12-11 |
| MEDTRONIC CARELINK 2290 (P890003/S263) | Medtronic, Inc. | 2012-12-11 |
| ALAIR BRONCHIAL THERMOPLASTY SYSTEM (P080032/S011) | Boston Scientific Corp | 2012-12-11 |
| EXPRESS2 MONORAIL & OVER-THE-WIRE CORONARY STENT SYSTEM (P020009/S098) | Boston Scientific Scimed, Inc. | 2012-12-11 |
| ARCHITECT TOTAL PSA AND AXSYM TOTAL PSA (P910007/S036) | Abbott Laboratories | 2012-12-11 |
| CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROSTHESIS (P870056/S054) | Edwards Lifesciences, LLC | 2012-12-11 |
| VERIFLEX CORONARY STENT SYSTEM (P040016/S102) | Boston Scientific Scimed, Inc. | 2012-12-11 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES RETROFLEX 3 DELIVERY SYSTEM RETROFLEX BALLOON CATHETER EDWARDS (P100041/S017) | Edwards Lifesciences, LLC | 2012-12-11 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S099) | Boston Scientific Corp | 2012-12-11 |
| VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S005) | Boston Scientific Corp | 2012-12-11 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S063) | Boston Scientific Corp | 2012-12-11 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S038) | Boston Scientific Corp | 2012-12-11 |
| WALLSTENT TIPS ENDOPROSTHESIS (P930031/S039) | Boston Scientific Corp | 2012-12-11 |