| XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS) (P110019/S034) | Abbott Vascular | 2012-10-23 |
| XIENCE AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S101) | Abbott Vascular, Inc. | 2012-10-23 |
| XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S077) | Abbott Vascular, Inc. | 2012-10-23 |
| PROGEL PLEURAL AIR LEAK SEALANT (P010047/S023) | Neomend, Inc. | 2012-10-23 |
| VISION AND ML8 CORONARY STENT SYSTEM (P020047/S051) | Abbott Vascular | 2012-10-23 |
| S-15 HYDRELLE (P050033/S015) | Anika Therapeutics, Inc. | 2012-10-22 |
| EN VISTA HYDROPHOBIC ACRYLIC INTRAOCULAR LENS (P910056/S013) | Bausch & Lomb, Inc. | 2012-10-19 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021) | Edwards Lifesciences, LLC | 2012-10-19 |
| EXABLATE (P110039) | Insightec | 2012-10-18 |
| COAPTITE INJECTABLE IMPLANT-1.0CC, 8005P10, COAPTITE INJECTABLE IMPLANT-1.0CC, 8005P10P (P040047/S024) | Merz North America, Inc. | 2012-10-18 |
| COBAS HPV TEST (P100020/S002) | Roche Molecular Systems, Inc. | 2012-10-18 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S036) | Zoll Manufacturing Corporation | 2012-10-18 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR (P090028/S003) | Ortho-Clinical Diagnostics, Inc. | 2012-10-17 |
| INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S044) | Medtronic Sofamor Danek USA, Inc. | 2012-10-17 |
| TELIGEN, INCEPTA, ENERGEN, PUNCTUA IMPLANTABLE CARDIOVERTER HIGH ENERGY DEFIBRILLATOR (P960040/S272) | Boston Scientific | 2012-10-17 |
| EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S012) | Exactech, Inc. | 2012-10-17 |
| RADIESSE INJECTABLE IMPLANT- 1.5CC, 8071M0, RADIESSE INJECTABLE IMPLANT-0.8CC, 8069M0, RADIESSE INJECTABLE IMPLANT-0.3CC (P050052/S037) | Merz North America, Inc. | 2012-10-17 |
| COFLEX® INTERLAMINAR TECHNOLOGY (P110008) | Companion Spine France | 2012-10-17 |
| RADIESSE INJECTABLE IMPLANT 1.5CC, 8071M0, RADIESSE INJECTABLE IMPLANT 0.8 CC, 8069M0, RADIESSE INJECTABLE IMPLANT- 0.3C (P050037/S034) | Merz North America, Inc. | 2012-10-17 |
| FREQUENCY XCEL TORIC XR (P850079/S057) | CooperVision, Inc. | 2012-10-17 |
| INFUSE BONE GRAFT (P000054/S031) | Medtronic Sofamor Danek USA, Inc. | 2012-10-17 |
| INFUSE BONE GRAFT (P050053/S022) | Medtronic, Inc. | 2012-10-17 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK AND CALIBRATOR (P100001/S002) | Ortho-Clinical Diagnostics | 2012-10-17 |
| COGNIS, INCEPTA, ENERGEN, PUNCTUA CARDIAC RESYNCHRONIZATION THERAPY HIGH EVERGY DEFIBRILLATOR (P010012/S304) | Boston Scientific Corp | 2012-10-17 |
| QUARTET IS4 LEAD MODELS 1458Q (P030054/S232) | ABBOTT MEDICAL | 2012-10-16 |
| ANGIOJET RHEOLOYTIC THROMBECTOMY SYSTEM (P980037/S040) | Boston Scientific Corp | 2012-10-16 |
| DURATA DF-4 LEAD MODELS 7120Q, 7121Q, 7170Q, 7171Q, 7172Q (P950022/S083) | ABBOTT MEDICAL | 2012-10-16 |
| MEDSTREAM PROGRAMMABLE INFUSION SYSTEM (P890055/S043) | Intera Oncology | 2012-10-16 |
| CAPSUREFIX MRI LEAD, 5086MRI (P090013/S074) | Medtronic, Inc. | 2012-10-15 |
| ADVIA CENTAUR HCV ASSAY (P030056/S007) | Siemens Healthcare Diagnostics | 2012-10-15 |
| COMBI 40+ COCHLEAR IMPLANT SYSTEM (MAESTRO COCHLEAR SYSTEM) (P000025/S065) | Med-El Corp. | 2012-10-15 |
| ADVIA CENTAUR HBSAG AND HBSAG CONFIRMATORY ASSAYS (P030049/S010) | Siemens Healthcare Diagnostics | 2012-10-15 |
| ATTAIN STARFIX LEAD, 4195 (P060039/S037) | Medtronic, Inc. | 2012-10-15 |
| ADVIA CENTAUR HBC IGM ASSAY (P030040/S008) | Siemens Healthcare Diagnostics | 2012-10-15 |
| ADVIA CENTAUR ANTI-HBS ASSAY (P030029/S013) | Siemens Healthcare Diagnostics | 2012-10-15 |
| ADVIA CENTAUR CPSA ASSAY (P990055/S014) | Siemens Healthcare Diagnostics | 2012-10-15 |
| ABBOTT ARCHITECT HBSAG QUALITATIVE/ ARCHITECT HBSAG QUALITATIVE CONFIRMATORY (P110029/S005) | Abbott Laboratories | 2012-10-15 |
| ANCHORING SLEEVE KIT, 5867AS, SELECTSECURE LEAD, 3830 (P030036/S048) | Medtronic Cardiac Rhythm Disease Management | 2012-10-15 |
| SPRINT QUATTRO LEAD, 6935, 6935M, 6944, 6947, 6947M (P920015/S096) | Medtronic, Inc. | 2012-10-15 |
| ADVIA CENTAUR PSA ASSAY (P950021/S013) | Siemens Healthcare Diagnostics | 2012-10-15 |
| CAPSUREFIX NOVUS LEAD, 4076, 5076, VITATRON CRYSTALLINE LEADS, ICF09, ICQ09B (P930039/S074) | Medtronic, Inc. | 2012-10-15 |
| ABBOTT ARCHITECT HBSAG/ARCHITECT HBSAG CONFIRMATORY (P060007/S021) | Abbott Laboratories | 2012-10-15 |
| ADVIA CENTAUR AFP ASSAY (P930036/S005) | Siemens Healthcare Diagnostics, Inc. | 2012-10-15 |
| ADAPTA, ADAPTA L, ADAPTA S, SENSIA L, SENSIA, VERSA IPG (P980035/S293) | Medtronic, Inc. | 2012-10-15 |
| ATTAIN BIPOLAR OTW LEAD, 4194, LEFT VENTRICULAR PACING LEAD, 4193 (P010015/S179) | Medtronic, Inc. | 2012-10-15 |
| ADVIA CENTAUR HBC TOTAL ASSAY (P040004/S009) | Siemens Healthcare Diagnostics | 2012-10-15 |
| APTIMA HPV 16 18/45 GENOTYPE ASSAY (P120007) | Gen-Probe Incorporated | 2012-10-12 |
| MEDSTREAM PROGRAMMABLE INFUSION SYSTEM, 91-4200US, 91-4201US, 91-4205US (P890055/S045) | Intera Oncology | 2012-10-12 |
| EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003/S016) | Boston Scientific Corporation | 2012-10-12 |
| EXOSEAL VASCULAR CLOSURE DEVICE (P100013/S006) | Cordis US Corporation | 2012-10-12 |
| XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P110019/S033) | Abbott Vascular | 2012-10-11 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S143) | Boston Scientific Corp | 2012-10-11 |
| COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0 (P000012/S040) | Roche Molecular Systems, Inc. | 2012-10-10 |
| GEL-ONE (P080020/S002) | Seikagaku Corp. | 2012-10-10 |
| NEUROSTIMULATOR IMPANTABLE INTERSTIM FAMILY (P970004/S142) | Medtronic Neuromodulation | 2012-10-10 |
| ACTIVA PC, ACTIVA SC, ACTIVA RC IMPLANTABLE NEUROSTIMULATORS (P960009/S157) | Medtronic, Inc. | 2012-10-10 |
| DURATA, DURATA DF4 (P950022/S084) | ABBOTT MEDICAL | 2012-10-10 |
| CURRENT, CURRENT ACCEL, CURRENT+, CURRENT RF, FORTIFY, EPIC/EPIC+, ATLAS/II/+ (P910023/S304) | ABBOTT MEDICAL | 2012-10-10 |
| EVIA PACEMAKER FAMILY (P950037/S112) | Biotronik, Inc. | 2012-10-10 |
| IDENTITY, INTEGRITY, AFFINITY, VERITY, VICTORY, ZEPHYR, SUSTAIN, ACCENT (P880086/S226) | ABBOTT MEDICAL | 2012-10-10 |
| LINOX LEAD FAMILY (P980023/S048) | Biotronik, Inc. | 2012-10-10 |
| REGENCY (P880006/S083) | St. Jude Medical, Inc. | 2012-10-10 |
| THINLINE/FINELINE FAMILY OF ENDOCARDIAL PACING LEADS AND ACCESSORIES (P960004/S056) | Boston Scientific | 2012-10-10 |
| MICRONY (P970013/S052) | ABBOTT MEDICAL | 2012-10-10 |
| ISOFLEX P, ISOFLEX OPTIM, ISOFLEX S (P960030/S037) | ABBOTT MEDICAL | 2012-10-10 |
| EXTERNAL NEUROSTIMULATOR,ITREL4,ITREL4X,RESTORE PRIME,PRIMEADVANCED,RESTORE,RESTORE ULTRA,RESTORE ADVANCED & SENSOR (P840001/S227) | Medtronic Neuromodulation | 2012-10-10 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV V2.0 TEST FOR USE WITH THE HIGH PURE SYSTEM (P060030/S029) | Roche Molecular Systems, Inc. | 2012-10-10 |
| NEUROSTIMULATOR IMPLANTABLE INTERSTIM FAMILY (P080025/S038) | Medtronic Neuromodulation | 2012-10-10 |
| LUMAX ICD FAMILY (P050023/S055) | Biotronik, Inc. | 2012-10-10 |
| ARCTIC FRONT CARDIAC CRYOABLATION CATHETERS (P100010/S019) | Medtronic Cryocath, LP | 2012-10-10 |
| QUICKSITE, QUICKFLEX, QUICKFLEX MICRO, QUARTET, PROMOTE, PROMOTE+, PROMOTE RF, PROMOTE ACCEL, PROMOTE Q,PROMOTE QUADRA (P030054/S233) | ABBOTT MEDICAL | 2012-10-10 |
| COROX LEAD FAMILY (P070008/S034) | Biotronik, Inc. | 2012-10-10 |
| COBAS AMPLIPREP/COBAS TAQMAN HBV V2.0 TEST FOR USE WITH THE HIGH PURE SYSTEM (P050028/S027) | Roche Molecular Systems, Inc. | 2012-10-10 |
| COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR, 0146 (P870025/S011) | Ge Medical Systems, Inc. | 2012-10-10 |
| ANTHEM, FRONTIER II (P030035/S104) | ABBOTT MEDICAL | 2012-10-10 |
| TENDRIL SDX, TENDRIL ST, TENDRIL STS, OPTISENSE (P960013/S074) | ABBOTT MEDICAL | 2012-10-10 |
| ABBOTT MEDICAL OPTICS (AMO) HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (P110007/S001) | Johnson & Johnson Surgical Vision, Inc. | 2012-10-09 |
| RX HERCULINK ELITE RENAL STENT SYSTEM (P110001/S009) | Abbott Vascular | 2012-10-09 |
| ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT (P020018/S046) | Cook, Inc. | 2012-10-09 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE (MAPHV) (P060038/S012) | Corcym Canada Corp | 2012-10-09 |
| ENDOTAK LEAD SYSTEM FAMILY (P910073/S105) | Boston Scientific | 2012-10-05 |
| THINLINE/FINELINE LEADS FAMILIES (P960004/S054) | Boston Scientific | 2012-10-05 |
| VENTAK AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM FAMILY (P830060/S072) | Boston Scientific | 2012-10-05 |
| VENTAK P /P2 AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM FAMILIES (P930035/S022) | Boston Scientific | 2012-10-05 |
| CONTAK CD, EASYTRAK, LIVIAN, COGNIS, AND ACUITY SPIRAL FAMILIES (P010012/S295) | Boston Scientific Corp | 2012-10-05 |
| AMS ACTICON NEOPHINCTER (P010020/S026) | Boston Scientific Corp | 2012-10-05 |
| CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) (P030005/S087) | Guidant Corp. | 2012-10-05 |
| CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) (P010012/S303) | Boston Scientific Corp | 2012-10-05 |
| XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM & XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S018) | Abbott Vascular | 2012-10-05 |
| VENTAK AV AND PRIZM DR/VR, VITALITY, CONFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVERTER DEBRILLAOR (AICD) SYSTEM (P960040/S265) | Boston Scientific | 2012-10-05 |
| VENTAK PRX AND VENTAK MINI AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) FAMILIES (P910077/S122) | Boston Scientific | 2012-10-05 |
| AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S093) | Boston Scientific Corp | 2012-10-05 |
| IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) (P960040/S271) | Boston Scientific | 2012-10-05 |
| DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM (P120005) | Dexcom, Inc. | 2012-10-05 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S024) | ABBOTT MEDICAL | 2012-10-05 |
| OVATION ABDOMINAL STENT GRAFT SYSTEM (P120006) | Endologix, LLC | 2012-10-05 |
| AMS 800 URINARY CONTROL SYSTEM (P000053/S045) | Boston Scientific Corp | 2012-10-05 |
| CAPSUREFIX MRI SURESCAN LEAD, 5086MRI (P090013/S073) | Medtronic, Inc. | 2012-10-04 |
| VITAGEL SURGICAL HEMOSTAT (P050044/S024) | Stryker Corp. | 2012-10-04 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S092) | Edwards Lifesciences, LLC | 2012-10-04 |