| BIOMET BHS-MINI (P790002/S029) | Ahp Eos Buyer, Inc. | 2012-12-31 |
| MACROPLASTIQUE IMPLANTS, MPQ-2.5 (P040050/S010) | Uroplasty, LLC | 2012-12-28 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIO (P860057/S099) | Edwards Lifesciences, LLC | 2012-12-28 |
| PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S146) | Boston Scientific Corp | 2012-12-28 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S007) | Medtronic | 2012-12-28 |
| EXOSEAL VASCULAR CLOSURE DEVICE (P100013/S008) | Cordis US Corporation | 2012-12-28 |
| HANCOCK II PORCINE BIOPROSTHESIS (P980043/S037) | Medtronic, Inc. | 2012-12-28 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S117) | Boston Scientific Corp | 2012-12-28 |
| AFX ENDOVASCULAR AAA SYSTEM (P040002/S040) | Endologix, LLC | 2012-12-28 |
| MOSAIC PORCINE BIOPROSTHESIS (P990064/S045) | Medtronic, Inc. | 2012-12-28 |
| DUNE MEDICAL DEVICES MARGINPROBE SYSTEM (P110014) | Dilon Medical Technologies, Ltd. | 2012-12-27 |
| THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S050) | Thoratec Laboratories Corp. | 2012-12-27 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S050) | W. L. Gore & Associates, Inc. | 2012-12-27 |
| VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S034) | Vistakon, Division of Johnson & Johnson Vision Car | 2012-12-27 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S079) | W. L. Gore & Associates, Inc. | 2012-12-27 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S003) | Medtronic | 2012-12-27 |
| IMPLANTABLE MINIATURE TELESCOPE (IMT) (P050034/S007) | Samsara Vision, Inc. | 2012-12-27 |
| SPRINT QUATTRO LEAD (P920015/S101) | Medtronic, Inc. | 2012-12-26 |
| ATTAIN BIPOLAR OTW LEAD (P010015/S185) | Medtronic, Inc. | 2012-12-26 |
| ATTAIN STARFIX LEAD (P060039/S040) | Medtronic, Inc. | 2012-12-26 |
| SPECTRANETICS LASER SHEATHS SLS (P960042/S045) | Spectranetics (Philips) | 2012-12-26 |
| GORE HELIX SEPTAL OCCLUDER (P050006/S033) | W. L. Gore & Associates, Inc. | 2012-12-26 |
| ELECSYS TOTAL PSA CALSET (P990056/S019) | Roche Diagnostics Corp. | 2012-12-26 |
| CAPSURE LEAD, VITATRON CRYSTALINE LEAD, VITATRON EXCELLENCE PS + LEAD (P830061/S083) | Medtronic Cardiac Rhythm Disease Management | 2012-12-26 |
| PATHVYSION HER-2 DNA PROBE KIT (P980024/S009) | Abbott Molecular, Inc. | 2012-12-26 |
| CASUREFIX NOVUS LEAD, VITATRON CRYSTALLINE LEAD (P930039/S079) | Medtronic, Inc. | 2012-12-26 |
| ENDURANT STENT GRAFT SYSTEM (P100021/S018) | Medtronic Vascular | 2012-12-26 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S002) | Medtronic | 2012-12-26 |
| VYSIS ALK BREAK APART FISH PROBE KIT (P110012/S002) | Abbott Molecular, Inc. | 2012-12-26 |
| ATTAIN ABILITY LEAD (P080006/S048) | Medtronic, Inc. | 2012-12-26 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S062) | Spectranetics Corp. | 2012-12-26 |
| TELIGEN 4-SITE HEADER ICD MODELS (P960040/S262) | Boston Scientific | 2012-12-21 |
| EXPRESS CORONARY STENT SYSTEM (P020009/S101) | Boston Scientific Scimed, Inc. | 2012-12-21 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S039) | Boston Scientific Corp | 2012-12-21 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM (P030026/S027) | Ortho-Clinical Diagnostics, Inc. | 2012-12-21 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S080) | W. L. Gore & Associates, Inc. | 2012-12-21 |
| ENDOTAK RELIANCE 4-SITE LEAD AND ACCESSORY MODELS (P910073/S102) | Boston Scientific | 2012-12-21 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S066) | Boston Scientific Corp | 2012-12-21 |
| OVATIO DR AND VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P980049/S061) | MicroPort CRM USA, Inc. | 2012-12-21 |
| XIENCE XPEDITION, XIENCE XPEDITION SV, AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S025) | Abbott Vascular | 2012-12-21 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S134) | Boston Scientific Corp | 2012-12-21 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S001) | Medtronic | 2012-12-21 |
| GORE EXCLUDER AAA ENDOPROSTHESIS WITH C3 DELIVERY SYSTEM (P020004/S078) | W. L. Gore & Associates, Inc. | 2012-12-21 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ABEAG (P090028/S006) | Ortho-Clinical Diagnostics, Inc. | 2012-12-21 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE (P100001/S005) | Ortho-Clinical Diagnostics | 2012-12-21 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S102) | Boston Scientific Corp | 2012-12-21 |
| OXFORD PARTIAL KNEE SYSTEM (P010014/S040) | Biomet Manufacturing Corp | 2012-12-21 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S042) | Boston Scientific Corp | 2012-12-21 |
| EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003/S020) | Boston Scientific Corporation | 2012-12-21 |
| COGNIS 4-SITE HEADER CRT-D MODELS (P010012/S292) | Boston Scientific Corp | 2012-12-21 |
| RF ENCHANCER II ABLATION CATHETER (P930029/S038) | Medtronic, Inc. | 2012-12-21 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S100) | Boston Scientific Corp | 2012-12-21 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S026) | Boston Scientific Corp | 2012-12-21 |
| VERIFLEX (LIBERTE) BARE METAL CORONARY STENT SYSTEM (P040016/S106) | Boston Scientific Scimed, Inc. | 2012-12-21 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S002) | Medtronic Vascular | 2012-12-21 |
| PINNACLE COMPLETE ACETABULAR HIP SYSTEM (P090002/S007) | DePuy Orthopaedics, Inc. | 2012-12-21 |
| RELIANCE 4-SITE DEFIBRILLATOR LEAD (P910073/S107) | Boston Scientific | 2012-12-20 |
| ELECSYS ANTI-HCV IMMUNOASSAY (COBAS E 601) AND PRECICONTROL ANTI-HCV (P090008/S012) | Roche Diagnostics Corp. | 2012-12-20 |
| ELECSYS ANTI-HCV ON COBAS E 411 (P090007/S007) | Roche Diagnostics Corp. | 2012-12-20 |
| CAPSURE LEAD, VITATRON CRYSTALINE LEAD, VITATRON EXCELLENCE PS + LEAD (P830061/S082) | Medtronic Cardiac Rhythm Disease Management | 2012-12-20 |
| ELECSYS ANTI-HBC ON MODULAR ANALYTICS E170 (P100031/S005) | Roche Diagnostics Corp. | 2012-12-20 |
| ADAPTOR (P820003/S119) | Medtronic Cardiac Rhythm Disease Management | 2012-12-20 |
| VITATRON C20 SR IPG, VITATRON C60 DR IPG, VITATRON T20 SR IPG, VITATRON T60 DR IPG (P990001/S109) | Medtronic, Inc. | 2012-12-20 |
| ELECSYS HBSAG (P990012/S013) | Roche Diagnostics Corp. | 2012-12-20 |
| RF CONDUCTR, RF CONTACTR, RF ENHANCER II, RF MARINR, RF MARINR UNIPOLAR (P930029/S037) | Medtronic, Inc. | 2012-12-20 |
| ACE HEADER, DEFIBRILLATION SUPPORT DEVICE (DISD), END CAP, EPICARDIAL PATCH LEAD, SIZING SLEEVE, UPSIZING SLEEVE (P900061/S118) | Medtronic Cardiac Rhythm Disease Management | 2012-12-20 |
| ATTAIN BIPOLAR OTW LEAD, CONSULTA CRT-P, LEFT VENTRICULAR PACING LEAD, SYNCRA CRT-P (P010015/S184) | Medtronic, Inc. | 2012-12-20 |
| CAPSURE LEAD, PRODIGY IPG, SERVICE KIT-PACEMAKER REPAIR KIT (P890003/S266) | Medtronic, Inc. | 2012-12-20 |
| ISOMED (P990034/S029) | Medtronic, Inc. | 2012-12-20 |
| CONCERTO ICD, CONCERTO II CRT-D & DF4 ICD, CONSULTA ICD, INSYNC II MARQUIS ICD, INSYNC MAXIMO ICD, MAXIMO II CRT-D (P010031/S342) | Medtronic Cardiac Rhythm Disease Management | 2012-12-20 |
| PRECICONTROL ANTI-HBC IGM (COBAS E 411) (P110031/S008) | Roche Diagnostics Corp. | 2012-12-20 |
| PRECICONTROL ANTI-HBC (ELECSYS) 2010 (P100032/S008) | Roche Diagnostics Corp. | 2012-12-20 |
| TARGIS TARGETED TRANSURETHRAL THERMOABLATION SYSTEM (TARGIS SYSTEM): NEW POUCH SEALER (P970008/S062) | Urologix, LLC | 2012-12-20 |
| PRECICONTROL HBSAG (P990012/S019) | Roche Diagnostics Corp. | 2012-12-20 |
| ELECSYS ANTI-HCV IMMUNOASSAY (COBAS E 411) AND PRECICONTROL ANTI-HCV (P090007/S011) | Roche Diagnostics Corp. | 2012-12-20 |
| ATTAIN ABILITY LEAD (P080006/S047) | Medtronic, Inc. | 2012-12-20 |
| ELECSYS ANTI-HBC IGM ON COBAS E 601 (P110022/S002) | Roche Diagnostics Corp. | 2012-12-20 |
| ELECSYS ANTI-HCV ON COBAS E 601 (P090008/S008) | Roche Diagnostics Corp. | 2012-12-20 |
| ELECSYS ANTI-HCV ON MODULAR ANALYTICS E170 (P090009/S007) | Roche Diagnostics Corp. | 2012-12-20 |
| ELECSYS ANTI-HBC ON ELECSYS 2010 (P100032/S005) | Roche Diagnostics Corp. | 2012-12-20 |
| LIFEVEST WEARABLE DEBRILLATOR (P010030/S039) | Zoll Manufacturing Corporation | 2012-12-20 |
| ELECSYS ANTI-HBS (P010054/S018) | Roche Diagnostics Corp. | 2012-12-20 |
| REVO MRI IPG (P090013/S081) | Medtronic, Inc. | 2012-12-20 |
| ELECSYS ANTI-HBC IGM ON MODULAR ANALYTICS E170 (P110025/S002) | Roche Diagnostics Corp. | 2012-12-20 |
| INTRINSIC ICD, MARQUIS DR ICD, & VR ICD, MAXIMO DR ICD, MAXIMO II ICD & VR ICD, PROTECTA ICD & XT ICD, SECURA ICD (P980016/S392) | Medtronic Cardiac Rhythm Disease Management | 2012-12-20 |
| CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD, CAPSURE Z NOVUS LEAD, IMPULSE II LEAD (P850089/S091) | Medtronic Cardiac Rhythm Disease Management | 2012-12-20 |
| ANCHORING SLEEVE KIT, SELECTSECURE LEAD (P030036/S052) | Medtronic Cardiac Rhythm Disease Management | 2012-12-20 |
| PRECICONTROL ANTI-HBC IGM (MODULAR ANALYTICS E170) (P110025/S008) | Roche Diagnostics Corp. | 2012-12-20 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S037) | Zoll Manufacturing Corporation | 2012-12-20 |
| CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, SURFIX LEAD, TORQUE CLIP DEVICE -ACCESSORY FOR 5076 LEAD, VITATRON CRYSTALLINE L (P930039/S078) | Medtronic, Inc. | 2012-12-20 |
| ELECSYS ANTI-HBC IGM ON COBAS E 411 (P110031/S002) | Roche Diagnostics Corp. | 2012-12-20 |
| CAPSURE EPICARDIAL PACKING LEAD (P950024/S046) | Medtronic, Inc. | 2012-12-20 |
| PRECICONTROL ANTI-HBS (P010054/S021) | Roche Diagnostics Corp. | 2012-12-20 |
| TRANSVENE LEAD (P980050/S079) | Medtronic, Inc. | 2012-12-20 |
| ACUITY SPIRAL AND EASYTRAK 3 IS-1 LEADS (P010012/S315) | Boston Scientific Corp | 2012-12-20 |
| ACUITY STEERABLE LEAD FAMILY (P050046/S019) | Guidant Corp. | 2012-12-20 |
| PRECICONTROL ANTI-HBC (MODULAR ANALYTICS E170) (P100031/S010) | Roche Diagnostics Corp. | 2012-12-20 |
| ADAPTA, SENSIA, VERSA IPG, ADVISA DR IPG, RELIA IPG (P980035/S301) | Medtronic, Inc. | 2012-12-20 |
| ATTAIN STARFIX LEAD (P060039/S039) | Medtronic, Inc. | 2012-12-20 |
| ELECSYS ANTI-HCV IMMUNOASSAY (MODULAR ANALYTICS E170) AND PRECICONTROL ANTI-HCV (P090009/S011) | Roche Diagnostics Corp. | 2012-12-20 |