| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S025) | W. L. Gore & Associates, Inc. | 2011-10-27 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S036) | W. L. Gore & Associates, Inc. | 2011-10-27 |
| SOLESTA (P100014/S004) | Palette Life Sciences | 2011-10-27 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S024) | W. L. Gore & Associates, Inc. | 2011-10-27 |
| VNS THERAPY GENERATORS, LEADS PROGRAMING SOFTWARE, PROGRAMMING WAND AND ASSCCESORY PACK (P970003/S138) | LivaNova USA, Inc. | 2011-10-27 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S038) | W. L. Gore & Associates, Inc. | 2011-10-27 |
| ANGIOSCULPT PTCA SCORING BALLOON CATHETER (P050018/S015) | Spectranetics Corp. | 2011-10-27 |
| TARGIS SYSTEM (P970008/S059) | Urologix, LLC | 2011-10-26 |
| HARMONY HIRESOLUTION BIONIC EAR SYSTEM (P960058/S092) | Advanced Bionics | 2011-10-26 |
| ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM (P110022) | Roche Diagnostics Corp. | 2011-10-26 |
| AMS 800 URINARY CONTROL SYSTEM (P000053/S039) | Boston Scientific Corp | 2011-10-26 |
| TELIGEN ICDS (P010012/S272) | Boston Scientific Corp | 2011-10-26 |
| VISTAKON (SENSOFILCON A) BRAND CONTACT LENSES (P040045/S027) | Vistakon, Division of Johnson & Johnson Vision Car | 2011-10-26 |
| LIFESTENT SOLO VASCULAR STENT SYSTEM (P070014/S026) | Bard Peripheral Vascular, Inc. | 2011-10-26 |
| LIMULUS AMEBOCYTE LYSATE BACTERIA TEST (P080004/S009) | Hoya Surgical Optics, Inc. | 2011-10-26 |
| COGNIS CRT-D (P960040/S246) | Boston Scientific | 2011-10-26 |
| ACTICON NEOSPHINCTER (P010020/S021) | Boston Scientific Corp | 2011-10-26 |
| AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S089) | Boston Scientific Corp | 2011-10-26 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S030) | Zoll Manufacturing Corporation | 2011-10-26 |
| COBAS 4800 BRAF V600 MUTATION TEST (P110020/S002) | Roche Molecular Systems, Inc. | 2011-10-26 |
| ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM (P110011) | Medtronic, Ireland | 2011-10-26 |
| ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OTW) (P100023/S002) | Boston Scientific Corp | 2011-10-25 |
| ENDEAVOR SPRINT ZOTARLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S066) | Medtronic, Inc. | 2011-10-25 |
| CVX EXCIMER LASER SYSTEMS (P910001/S049) | Spectranetics Corp. | 2011-10-25 |
| ACRYSOF IQ TORIC INTAOCULAR LENS (P930014/S048) | Alcon Laboratories, Inc. | 2011-10-25 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S042) | W. L. Gore & Associates, Inc. | 2011-10-24 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S065) | W. L. Gore & Associates, Inc. | 2011-10-24 |
| ACTIVA FAMILY INSS (P960009/S127) | Medtronic, Inc. | 2011-10-21 |
| VNS THERAPY SYSTEM (P970003/S137) | LivaNova USA, Inc. | 2011-10-21 |
| PRODIGY (P890003/S236) | Medtronic, Inc. | 2011-10-21 |
| AMPLATZER SEPTAL OCCLUDER, AMPLATZER 45 DELIVERY AND EXCHANGE SYSTEMS (PTFE) (P000039/S042) | ABBOTT MEDICAL | 2011-10-21 |
| INSYNC III (P010015/S140) | Medtronic, Inc. | 2011-10-21 |
| 350 SERIES/ADAPTA/ENPULSE/ENRHYTHM/RELIA/SENSIA/SIGMA/VERSA (P980035/S243) | Medtronic, Inc. | 2011-10-21 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S019) | ABBOTT MEDICAL | 2011-10-21 |
| BIOMEDICS 38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES (P780007/S046) | CooperVision, Inc. | 2011-10-21 |
| AMPLATZER DUCT OCCLUDER, AMPLATZER 180 DELIVERY AND EXCHANGE SYSTEMS (PTFE) (P020024/S034) | ABBOTT MEDICAL | 2011-10-21 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S119) | Boston Scientific Corp | 2011-10-21 |
| RESTOR FAMILY OF IMPLANTABLE NEUROSTIMULATORS (INSS) (P840001/S196) | Medtronic Neuromodulation | 2011-10-21 |
| VITATRON DA+ C & T SERIES IPGS (P990001/S097) | Medtronic, Inc. | 2011-10-21 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK & CALIBRATOR (P090028/S001) | Ortho-Clinical Diagnostics, Inc. | 2011-10-21 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S021) | W. L. Gore & Associates, Inc. | 2011-10-21 |
| AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS (P060022/S010) | Bausch & Lomb, Inc. | 2011-10-21 |
| MERLIN PATIENT CARE SYSTEM MODEL 3650 (P030054/S200) | ABBOTT MEDICAL | 2011-10-20 |
| ORAQUICK RAPID HCV ANTIBODY (P080027/S003) | OraSure Technologies, Inc. | 2011-10-20 |
| CADENCE/CURRENT FAMILY OF ICDS (P910023/S240) | ABBOTT MEDICAL | 2011-10-20 |
| EPIC/ATLAS/ PROMOTE FAMILY OF CRT-DS (P030054/S159) | ABBOTT MEDICAL | 2011-10-20 |
| QUANTIFERON -TB GOLD (P010033/S019) | Qiagen | 2011-10-20 |
| CONTINUOUS GLOCOSE MONITORING SYSTEM (P980022/S071) | Medtronic Minimed | 2011-10-20 |
| ENDEAVOR SPRINT CORONARY STENT SYSTEMS (P060033/S068) | Medtronic, Inc. | 2011-10-19 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S023) | W. L. Gore & Associates, Inc. | 2011-10-19 |
| TAXUS LIBERTE OTW PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S079) | Boston Scientific Corp | 2011-10-19 |
| DRIVER & MICRO DRIVER CORONARY STENT SYSTEMS (P030009/S060) | Medtronic, Ireland | 2011-10-19 |
| TALENT THORACIC STENT GRAFT WITH THE XCELERANT DELIVERY SYSTEM (P070007/S032) | Medtronic Vascular | 2011-10-19 |
| AXSYM ANTI-HCV (P970027/S016) | Abbott Laboratories | 2011-10-19 |
| EXPRESS & EXPRESS2 CORONARY STENT SYSTEMS (P020009/S078) | Boston Scientific Scimed, Inc. | 2011-10-19 |
| NEOMEND PROGEL PLEURAL AIR LEAK SEALANT (P010047/S013) | Neomend, Inc. | 2011-10-19 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S022) | Boston Scientific Corp | 2011-10-19 |
| TALENT ABDOMINAL STENT GRAFT WITH THE XCELERANT SYSTEM & TALENT CONVERTER STENT GRAFT WITH THE XCELERANT SYSTEM (P070027/S033) | Medtronic Vascular | 2011-10-19 |
| TRIFECTA VALVE (P100029/S009) | ABBOTT MEDICAL | 2011-10-19 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S024) | Boston Scientific Corp | 2011-10-19 |
| VERIFLEX (FORMERLY LIBERTE) OTW BARE METAL CORONARY STENT SYSTEM (P040016/S079) | Boston Scientific Scimed, Inc. | 2011-10-19 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S068) | Terumo Medical Corporation | 2011-10-18 |
| VNS THERAPY SYSTEM (P970003/S136) | LivaNova USA, Inc. | 2011-10-18 |
| CYBERONICS VNS THERAPY (P970003/S065) | LivaNova USA, Inc. | 2011-10-17 |
| ROCHE COBAS 4800 BRAF V600 MUTATION TEST (P110020/S001) | Roche Molecular Systems, Inc. | 2011-10-17 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S078) | Boston Scientific Scimed, Inc. | 2011-10-14 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S021) | Boston Scientific Corp | 2011-10-14 |
| PARADIGM REAL-TIME PUMP (P980022/S093) | Medtronic Minimed | 2011-10-14 |
| BIRMINGHAM HIP RESURFACING SYSTEM (BHR) (P040033/S017) | Smith & Nephew, Inc. | 2011-10-14 |
| SUSTAIN XL SC, DC, SR, DR PACEMAKER MODELS PM1134, PM2134, PM1136, PM2136 (P880086/S210) | ABBOTT MEDICAL | 2011-10-14 |
| BAUSCH & LOMB SILSOFT (ELASTOFILCON A) CONTACT LENS (P850068/S009) | Bausch & Lomb, Inc. | 2011-10-14 |
| REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS) (P030022/S017) | Smith & Nephew, Inc. | 2011-10-14 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S077) | Boston Scientific Corp | 2011-10-14 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S078) | Boston Scientific Corp | 2011-10-14 |
| FEM CAP (P020041/S002) | Femcap Incorporated | 2011-10-13 |
| ADAPTA/ADVISA/ENRHYTHM/RELIA/SENSIA/VERSA (P980035/S241) | Medtronic, Inc. | 2011-10-13 |
| VITATRON DA+ C SERIES & VITATRO DA+ T SERIES IPG (P990001/S095) | Medtronic, Inc. | 2011-10-13 |
| REVO MRI (P090013/S039) | Medtronic, Inc. | 2011-10-13 |
| CONSULTA CRT-P & SYNCRA CRT-P (P010015/S138) | Medtronic, Inc. | 2011-10-13 |
| TRIFECTA VALVE (P100029/S004) | ABBOTT MEDICAL | 2011-10-13 |
| ENTRUST/INTRINSIC/MARQUIS/MAXIMO/MAXIMO II/PROTECTA/PROTECTA XT/SECURA/VIRTUOSO/VIRTUOSO II (P980016/S322) | Medtronic Cardiac Rhythm Disease Management | 2011-10-13 |
| INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (P100027/S001) | Ventana Medical Systems, Inc. | 2011-10-13 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S020) | W. L. Gore & Associates, Inc. | 2011-10-13 |
| CONCERTO/CONCERTO II/CONSULTA/INSYNC II & III MARQUIS/INSYNC MAXIMO/INSYNC SENTRY/MAXIMO PROTECTA/PROTECTA XT (P010031/S276) | Medtronic Cardiac Rhythm Disease Management | 2011-10-13 |
| RESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY CATHETER & SYSTEM ACCESSORY EQUIPMENT (P020052/S008) | St Jude Medical | 2011-10-13 |
| BIOCOR & EPIC VALVES (P040021/S018) | ABBOTT MEDICAL | 2011-10-13 |
| CADENCE FAMILY OF ICDS (P910023/S275) | ABBOTT MEDICAL | 2011-10-12 |
| FETAL ACOUSTIC STIMULATOR (P870025/S010) | Ge Medical Systems, Inc. | 2011-10-12 |
| EPIC HF/ATLAS+ HF FAMILY OF CRT-DS (P030054/S203) | ABBOTT MEDICAL | 2011-10-12 |
| HER OPTION CRYOABLATION THERAPY SYSTEM (P000032/S036) | CooperSurgical, Inc. | 2011-10-12 |
| VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S025) | Vistakon, Division of Johnson & Johnson Vision Car | 2011-10-12 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S123) | Boston Scientific Corp | 2011-10-12 |
| RESTYLANE INJECTABLE GEL (P040024/S051) | Q-Med AB | 2011-10-11 |
| AMPLICOR HCV TEST V2.0 & COBAS AMPLICOR HCV TEST V2.0 (P000010/S025) | Roche Molecular Systems, Inc. | 2011-10-11 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S023) | Roche Molecular Systems, Inc. | 2011-10-11 |
| COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM (P050028/S022) | Roche Molecular Systems, Inc. | 2011-10-11 |
| ADVIA CENTAUR HBEAG ASSAY AND QUALITY CONTROL MATERIAL (P090024) | Siemens Healthcare Diagnostics | 2011-10-11 |
| COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST V2.0 (P000012/S035) | Roche Molecular Systems, Inc. | 2011-10-11 |
| INTERSTIM SACRAL NERVE STIMULATION THERAPY FOR BOWEL CONTROL (P080025/S021) | Medtronic Neuromodulation | 2011-10-11 |
| EUFLEXXA (1% SODIUM HYALURONATE) (P010029/S008) | Ferring Pharmaceuticals, Inc. | 2011-10-11 |