| ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S060) | Boston Scientific Corp | 2012-11-29 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM (P110010/S034) | Boston Scientific Corp | 2012-11-29 |
| TELIGEN, INCEPT, ENERGEN AND PUNCTUA ICDS (P960040/S280) | Boston Scientific | 2012-11-29 |
| RESTYLANE INJECTABLE GEL (P040024/S064) | Q-Med AB | 2012-11-29 |
| COGNIS, INCEPTA, ENERGEN, PUNCTUA CRTS (P010012/S313) | Boston Scientific Corp | 2012-11-29 |
| THORATEC VENTRICULAR ASSIST DEVICE (VAD) (P870072/S051) | Thoratec Laboratories Corp. | 2012-11-29 |
| CAPSUREFIX NOVUS LEAD (P930039/S077) | Medtronic, Inc. | 2012-11-28 |
| ABBOTT ARCHITECT AFP ASSAY (P120008) | Abbott Laboratories | 2012-11-28 |
| CAPSUREFIX MRI LEAD (P090013/S079) | Medtronic, Inc. | 2012-11-28 |
| ARCHITECT CORE (P080023/S016) | Abbott Laboratories | 2012-11-27 |
| ARCHITECT CORE-M (P060035/S015) | Abbott Laboratories | 2012-11-27 |
| CAPSURE EPI PACING LEADS (P950024/S044) | Medtronic, Inc. | 2012-11-27 |
| CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S011) | Boston Scientific Corp | 2012-11-27 |
| ARCHITECT HBSAG QUALITATIVE/CONFIMATORY (P110029/S007) | Abbott Laboratories | 2012-11-27 |
| CAPSURE EPI PACING LEADS (P950024/S040) | Medtronic, Inc. | 2012-11-27 |
| HER2 CISH PHARMDX KIT (P100024/S003) | Dako Denmark A/S | 2012-11-27 |
| ARCHITECT HBSAG/CONFIMATORY (P060007/S022) | Abbott Laboratories | 2012-11-27 |
| ARCHITECT AUSAB (P050051/S016) | Abbott Laboratories, Inc. | 2012-11-27 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S029) | W. L. Gore & Associates, Inc. | 2012-11-26 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK CALIBRATOR (P090028/S005) | Ortho-Clinical Diagnostics, Inc. | 2012-11-26 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC AND MITRAL VALVES (P860057/S095) | Edwards Lifesciences, LLC | 2012-11-26 |
| ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S061) | Boston Scientific Corp | 2012-11-23 |
| EXPRESS 2 CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE) (P020009/S096) | Boston Scientific Scimed, Inc. | 2012-11-23 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S095) | Boston Scientific Scimed, Inc. | 2012-11-23 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S062) | Boston Scientific Corp | 2012-11-23 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S033) | Boston Scientific Corp | 2012-11-23 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S036) | Boston Scientific Corp | 2012-11-23 |
| VERIFLEX CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE) (P040016/S101) | Boston Scientific Scimed, Inc. | 2012-11-23 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM (P110010/S036) | Boston Scientific Corp | 2012-11-23 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S059) | Boston Scientific Corp | 2012-11-23 |
| IOP (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S058) | Boston Scientific Corp | 2012-11-23 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S037) | Boston Scientific Corp | 2012-11-23 |
| VERIFLEX (LIBERTE) BARE-METAL CORONARY STENT SYSTEM (P040016/S100) | Boston Scientific Scimed, Inc. | 2012-11-23 |
| MI1000 MED-EL CONCERT PIN COCHLEAR IMPLANT (P000025/S058) | Med-El Corp. | 2012-11-21 |
| DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S009) | DePuy Orthopaedics, Inc. | 2012-11-21 |
| INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL (P100027/S004) | Ventana Medical Systems, Inc. | 2012-11-21 |
| BARD LIFESTENT VASCULAR STENT SYSTEMS (P070014/S035) | Bard Peripheral Vascular, Inc. | 2012-11-21 |
| DIMENSION FPSA FLEX REAGENT CARTRIDGE (P020027/S019) | Siemens Healthcare Diagnostics | 2012-11-20 |
| DEPUY CREAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S010) | DePuy Orthopaedics, Inc. | 2012-11-20 |
| DURALOC OPTION CERAMIC HIP SYSTEM (P040023/S025) | DePuy Orthopaedics, Inc. | 2012-11-20 |
| APLIGRAF (P950032/S069) | Organogenesis, Inc. | 2012-11-20 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S098) | Cochlear Americas | 2012-11-20 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM (P110010/S032) | Boston Scientific Corp | 2012-11-20 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S031) | Abbott Vascular | 2012-11-20 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S074) | W. L. Gore & Associates, Inc. | 2012-11-20 |
| CAPENTIER-EDWARDS PERIMOUNT THEON, THEON PSR, MAGNA, MAGNA EASE, PERICARDIAL AORTIC BIOPROSTHESIS (P860057/S094) | Edwards Lifesciences, LLC | 2012-11-20 |
| COPPERVISION METHAFILCON A SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES (P850079/S060) | CooperVision, Inc. | 2012-11-20 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S075) | W. L. Gore & Associates, Inc. | 2012-11-20 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S072) | Medtronic, Inc. | 2012-11-20 |
| DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S024) | Siemens Healthcare Diagnostics | 2012-11-20 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE (MAPHV) (P060038/S015) | Corcym Canada Corp | 2012-11-20 |
| OPEN PIVOT HEART VALVE (P990046/S030) | Medtronic Ats Medical, Inc. | 2012-11-20 |
| ENDURANT STENT GRAFT SYSTEM (P100021/S022) | Medtronic Vascular | 2012-11-20 |
| FREQUENCY 55, FREQUENCY 55 ASPHERIC, FREQUENCY XCEL TORIC, FREQUENCY 55 TORIC (P850079/S061) | CooperVision, Inc. | 2012-11-20 |
| PINNACLE COMPLETE ACETABULAR HIP SYSTEM (P090002/S006) | DePuy Orthopaedics, Inc. | 2012-11-20 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S057) | Boston Scientific Corp | 2012-11-20 |
| ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETERS (P100010/S021) | Medtronic Cryocath, LP | 2012-11-20 |
| WEARABLE CARDIOVERTER DEFIBRILLATOR (P010030/S038) | Zoll Manufacturing Corporation | 2012-11-20 |
| STOCKERT 70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION (P990071/S020) | Biosense Webster, Inc. | 2012-11-20 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047) | Medtronic | 2012-11-20 |
| ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM (P850048/S028) | Beckman Coulter, Inc. | 2012-11-19 |
| ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM (P090026/S001) | Beckman Coulter, Inc. | 2012-11-19 |
| ACCESS HYBRITECH FREE PSA REAGENT ON THE ACCESS IMMUNOASSAY SYSTEM (P970038/S017) | Beckman Coulter, Inc. | 2012-11-19 |
| SELECTSECURE 4 FRENCH LEAD, 3830 (P030036/S050) | Medtronic Cardiac Rhythm Disease Management | 2012-11-19 |
| ATTAIN ABILITTY LV LEAD, 4196, ATTAIN ABILITY PLUS LV LEAD, 4296, ATTAIN ABILITY STRAIGHT LV LEAD, 4296 (P080006/S046) | Medtronic, Inc. | 2012-11-19 |
| CAPSURE FIX MRI LEAD, 5086MRI (P090013/S078) | Medtronic, Inc. | 2012-11-19 |
| ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY (P110029/S006) | Abbott Laboratories | 2012-11-19 |
| ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S018) | Beckman Coulter, Inc. | 2012-11-19 |
| COBAS 4800 BRAF V600 MUTATION TEST (P110020/S004) | Roche Molecular Systems, Inc. | 2012-11-19 |
| COBAS HPV TEST (P100020/S005) | Roche Molecular Systems, Inc. | 2012-11-19 |
| CAPSURE SENSE LEAD, 4073, CAPSURE SENSE UNIPOLAR LEAD, CAPSURE BIPOLAR LEAD, VITATRON CRYSTALINE LEAD, VITATRON CRYSTALI (P830061/S081) | Medtronic Cardiac Rhythm Disease Management | 2012-11-19 |
| LCS TOTAL KNEE SYSTEM (P830055/S127) | Depuy, Inc. | 2012-11-19 |
| THERAKOS CELLEX INSTRUMENT, THERAKOS CELLEX PHOTOPHRESSIS PROCEDURAL KIT (125 ML), CLX, THERAKOS CELLEX LIGHT ASSEMBLY , (P860003/S067) | Therakos Development Limited | 2012-11-19 |
| CAPSURE FIX NOVUS LEAD, 4076 AND VITATRON CRYSTALLINE LEADS, ICQ09B (P930039/S076) | Medtronic, Inc. | 2012-11-19 |
| PRECISON SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S145) | Boston Scientific Corp | 2012-11-19 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE CALIBRATOR (P100001/S004) | Ortho-Clinical Diagnostics | 2012-11-19 |
| LCS TOTAL KNEE SYSTEM (P830055/S128) | Depuy, Inc. | 2012-11-19 |
| ENTRUSTICD,INTRINSIC ICD,MARQUIS DR ICD,MARQUIS VR ICD,MAXIMO DR ICD,MAXIMO II ICD,PROTECTA ICD,PROTECTA XT ICD (P980016/S387) | Medtronic Cardiac Rhythm Disease Management | 2012-11-16 |
| OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYTEM (P110043/S003) | Abbott Vascular-Cardiac Therapies | 2012-11-16 |
| REVO MRI IPG (P090013/S077) | Medtronic, Inc. | 2012-11-16 |
| PRODIGY IPG (P890003/S264) | Medtronic, Inc. | 2012-11-16 |
| CONCERTO ICD,CONCERTO II CRT-D,CONSULTA DF4 ICD,CONSULTA ICD,INSYNC III MARQUIS ICD,INSYNC MAXIMO ICD,MAXIMO II CRT-D (P010031/S339) | Medtronic Cardiac Rhythm Disease Management | 2012-11-16 |
| ADAPTA,ADAPTA L,ADAPTA S,SENSIA L,SENSIA,VERSA IPG,ADVISA DR IPG,ENRHYTHM IPG,RELIA,SIGMA DR IPG (P980035/S297) | Medtronic, Inc. | 2012-11-16 |
| PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S144) | Boston Scientific Corp | 2012-11-16 |
| CARELINK IPRO THERAPY MANAGEMENT SOFTWARE (P980022/S124) | Medtronic Minimed | 2012-11-16 |
| NOVASURE IMPENDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S045) | Hologic, Inc. | 2012-11-15 |
| QUANTIFERON -TB GOLD (P010033/S020) | Qiagen | 2012-11-15 |
| GLAUKOS CORPORATION ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM (P080030/S001) | Glaukos Corporation | 2012-11-15 |
| PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY (P020055/S004) | Ventana Medical Systems, Inc. | 2012-11-14 |
| ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (P110028/S005) | Abbott Vascular, Inc. | 2012-11-14 |
| INVIVE CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKER (P030005/S085) | Guidant Corp. | 2012-11-14 |
| RELIANCE IS-4 DEFIBRILLATION LEAD (P910073/S111) | Boston Scientific | 2012-11-14 |
| INCEPTA, ENERGEN, PUNCTUA, COGNIS, LIVIAN (P010012/S296) | Boston Scientific Corp | 2012-11-14 |
| ZILVER PTX DRUG-ELUTING PERIPHERAL STENT (P100022) | Cook Ireland, Ltd. | 2012-11-14 |
| PATHWAY ANTI-HER -2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S014) | Ventana Medical Systems, Inc. | 2012-11-14 |
| INFORM HER-2 DUAL DNA PROBE COCKTAIL (P100027/S003) | Ventana Medical Systems, Inc. | 2012-11-14 |
| LATITUDE/PROGRAMMER/RECORDER/MONITOR (P910077/S128) | Boston Scientific | 2012-11-14 |
| INCEPTA, ENERGEN, PUNCTUA, TELIGEN, CONFIENT (P960040/S266) | Boston Scientific | 2012-11-14 |
| ESTEEM (P090018/S011) | Envoy Medical Corporation | 2012-11-13 |
| AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S046) | Boston Scientific Corp | 2012-11-13 |