| DURASEAL DURAL SEALANT SYSTEM (P040034/S014) | Integra LifeSciences Corporation | 2009-12-08 |
| TRILOGY AB ACETABULAR SYSTEM (P040048/S010) | Zimmer, Inc. | 2009-12-08 |
| INSYNC/INSYNC III CRT-PS (P010015/S071) | Medtronic, Inc. | 2009-12-07 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S030) | Boston Scientific Corp | 2009-12-07 |
| XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S022) | Abbott Vascular, Inc. | 2009-12-07 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S031) | Boston Scientific Corp | 2009-12-07 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S075) | Boston Scientific Corp | 2009-12-07 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S076) | Boston Scientific Corp | 2009-12-07 |
| NAVISTAR RMT THERMOCOOL CATHETER (P030031/S019) | Biosense Webster, Inc. | 2009-12-07 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S077) | Boston Scientific Corp | 2009-12-07 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S043) | Boston Scientific Scimed, Inc. | 2009-12-07 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S044) | Boston Scientific Scimed, Inc. | 2009-12-07 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S039) | Boston Scientific Scimed, Inc. | 2009-12-04 |
| EXPRESS SD RENAL PREMOUNTED STENT SYSTEM (P060006/S001) | Boston Scientific Corp | 2009-12-04 |
| ASCENSION MCP (P000057/S005) | Smith & Nephew, Inc. | 2009-12-04 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S066) | Boston Scientific Corp | 2009-12-04 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S025) | Boston Scientific Corp | 2009-12-04 |
| SOLETRA, KINETRA IMPLANTABLE NEUROSTIMULATOR (P960009/S054) | Medtronic, Inc. | 2009-12-04 |
| PTCA CATHETERS (P860019/S244) | Scimed Life Systems, Inc. | 2009-12-04 |
| THORATEC HEARTMATE II LVAS (P060040/S004) | ABBOTT MEDICAL | 2009-12-04 |
| SYNCHROMED II PUMP MODEL 8637 (P860004/S116) | Medtronic, Inc. | 2009-12-04 |
| EXPRESS CORONARY STENT SYSTEM (P020009/S052) | Boston Scientific Scimed, Inc. | 2009-12-04 |
| APEX MONORAIL & OTW PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) DILATATION CATHETERS (P860019/S242) | Scimed Life Systems, Inc. | 2009-12-04 |
| SYNERGY FAMILY OF NEUROSTIMULATORS (P840001/S117) | Medtronic Neuromodulation | 2009-12-04 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S070) | Boston Scientific Corp | 2009-12-04 |
| ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S033) | Boston Scientific Corp | 2009-12-04 |
| TAXUS LIBERTE PACLITTAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S021) | Boston Scientific Corp | 2009-12-04 |
| DEXCON SEVEN SENSOR (P050012/S021) | Dexcom, Inc. | 2009-12-04 |
| TAXUS EXPRESS 2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S072) | Boston Scientific Corp | 2009-12-03 |
| ADVIA CENTAUR COMPLEXED (CPSA) & ADVIA CENTAUR CP CPSA IMMUNOASSAY (P990055/S010) | Siemens Healthcare Diagnostics | 2009-12-03 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S042) | Boston Scientific Scimed, Inc. | 2009-12-03 |
| CORMET HIP RESURFACING SYSTEM (P050016/S005) | Corin USA | 2009-12-03 |
| ELECSYS TOTAL PSA IMMUNOASSAY (P990056/S010) | Roche Diagnostics Corp. | 2009-12-03 |
| ADVIA CENTAUR PSA & ADVIA CENTAUR CP PSA IMMUNOASSAY (P950021/S009) | Siemens Healthcare Diagnostics | 2009-12-03 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S060) | Terumo Medical Corporation | 2009-12-03 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S068) | Boston Scientific Corp | 2009-12-03 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S027) | Boston Scientific Corp | 2009-12-03 |
| EXPRESS 2 CORONARY STENT SYSTEM (P020009/S055) | Boston Scientific Scimed, Inc. | 2009-12-03 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S023) | Boston Scientific Corp | 2009-12-03 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S029) | Boston Scientific Corp | 2009-12-02 |
| D-STAT FLOWABLE HEMOSTAT (P990037/S029) | Vascular Solutions, Inc. | 2009-12-02 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S022) | Boston Scientific Corp | 2009-12-02 |
| TAXUS EXPRESS 2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S074) | Boston Scientific Corp | 2009-12-02 |
| SCULPTRA (P030050/S006) | Q-Med AB | 2009-12-02 |
| FLAIR ENDOVASCULAR STENT GRAFT (P060002/S007) | Bard Peripheral Vascular | 2009-12-02 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S053) | Boston Scientific Scimed, Inc. | 2009-12-02 |
| PTCA CATHETERS (P860019/S245) | Scimed Life Systems, Inc. | 2009-12-02 |
| OCUCOAT (P860047/S023) | Bausch & Lomb, Inc. | 2009-12-02 |
| TAXUS EXPRESS 2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S071) | Boston Scientific Corp | 2009-12-02 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S026) | Boston Scientific Corp | 2009-12-02 |
| EXPRESS SD RENAL PREMOUNTED STENT SYSTEM (P060006/S002) | Boston Scientific Corp | 2009-12-02 |
| POLYMETHYMETHACRYLATE INTRAOCULAR LENSES (P880090/S027) | Bausch & Lomb, Inc. | 2009-12-02 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S003) | Boston Scientific Corp | 2009-12-02 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S017) | Zoll Manufacturing Corporation | 2009-12-02 |
| EXPRESS AND EXPRESS 2 CORONARY STENT SYSTEMS (P020009/S054) | Boston Scientific Scimed, Inc. | 2009-12-02 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S040) | Boston Scientific Scimed, Inc. | 2009-12-02 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S067) | Boston Scientific Corp | 2009-12-02 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S041) | Boston Scientific Scimed, Inc. | 2009-12-02 |
| SOFLEX & SOFPORT POSTERIOR CHAMBER INTRAOCULAR LENSES (P910061/S019) | Bausch & Lomb | 2009-12-02 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S058) | Cochlear Americas | 2009-12-02 |
| POLYMETHYMETHACRYLATE INTRAOCULAR LENSES (P840039/S059) | Bausch & Lomb, Inc. | 2009-12-02 |
| PARADIGM REAL-TIME PUMP (MMT-522, MMT-522K,MMT-722,MMT-722K) & GUARDIAN REAL-TIME MONITOR (CSS7100,CSS7100K) (P980022/S065) | Medtronic Minimed | 2009-12-01 |
| SEPRAFILM ADHESION BARRIER (P950034/S032) | Baxter Healthcare Corporation | 2009-11-30 |
| ST AIA-PACK PA (P910065/S007) | Tosoh Bioscience, Inc. | 2009-11-30 |
| BARD LIFESTENT VASCULAR STENT SYSTEMS (P070014/S005) | Bard Peripheral Vascular, Inc. | 2009-11-27 |
| SJM ICDS (P910023/S225) | ABBOTT MEDICAL | 2009-11-27 |
| SJM CRT-DS (P030054/S140) | ABBOTT MEDICAL | 2009-11-27 |
| PTCA CATHETERS (P860019/S243) | Scimed Life Systems, Inc. | 2009-11-25 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S020) | Boston Scientific Corp | 2009-11-25 |
| MEDTRONIC ACTIVA PARKINSON'S CONTROL THERAPY (P960009/S060) | Medtronic, Inc. | 2009-11-25 |
| NAVISTAR RMT (P990025/S021) | Biosense Webster, Inc. | 2009-11-25 |
| LATITUDE PATIENT MANAGEMENT SYSTEM (P910077/S097) | Boston Scientific | 2009-11-25 |
| NAVISTAR RMT THERMOCOOL (P030031/S018) | Biosense Webster, Inc. | 2009-11-25 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S065) | Boston Scientific Corp | 2009-11-25 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S051) | Boston Scientific Scimed, Inc. | 2009-11-25 |
| NAVISTAR RMT DS (P010068/S017) | Biosense Webster, Inc. | 2009-11-25 |
| MYNX VASCULAR CLOSURE DEVICE (P040044/S023) | Cordis US Corporation | 2009-11-25 |
| CARPENTIER-EDWARDS BIOPROSTHESIS (P870056/S035) | Edwards Lifesciences, LLC | 2009-11-25 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S021) | Edwards Lifesciences, LLC | 2009-11-25 |
| CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS (P010041/S020) | Edwards Lifesciences, LLC | 2009-11-25 |
| LIBERTE CORONARY STENT SYSTEM (P040016/S038) | Boston Scientific Scimed, Inc. | 2009-11-25 |
| CELSIUS RMT (P950005/S028) | Biosense Webster, Inc. | 2009-11-25 |
| SAFIRE CARDIAC ABLATION SYSTEM (P960016/S027) | St Jude Medical | 2009-11-25 |
| NAVISTAR RMT THERMOCOOL (P040036/S013) | Biosense Webster, Inc. | 2009-11-25 |
| MYNX VASCULAR CLOSURE DEVICE (P040044/S022) | Cordis US Corporation | 2009-11-25 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S014) | Zoll Manufacturing Corporation | 2009-11-25 |
| CARPENTIER-EDWARDS PERIMOUNT PERCARDIAL BIOPROSTHESIS (P860057/S061) | Edwards Lifesciences, LLC | 2009-11-25 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL (P870077/S032) | Edwards Lifesciences, LLC | 2009-11-25 |
| DURASEAL DURAL SEALANT SYSTEM (P040034/S015) | Integra LifeSciences Corporation | 2009-11-25 |
| SAFIRE CARDIAC ABLATION SYSTEM (P960016/S026) | St Jude Medical | 2009-11-25 |
| MULTI-LINK VISION FAMILY OF CORONARY STENT SYSTEMS (P020047/S016) | Abbott Vascular | 2009-11-24 |
| NAVISTAR AND CELSIUS THERMOCOOL CATHETERS (P030031/S020) | Biosense Webster, Inc. | 2009-11-24 |
| DEFLUX INJECTABLE GEL (P000029/S060) | Palette Life Sciences | 2009-11-24 |
| GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM (P990066/S034) | GE Healthcare | 2009-11-24 |
| SYNCHROMED INFUSION SYSTEM (P860004/S115) | Medtronic, Inc. | 2009-11-23 |
| PROLIEVE THERMODILITATION SYSTEM (P030006/S022) | Medifocus, Inc. | 2009-11-23 |
| MYNX VASCULAR CLOSURE DEVICE (P040044/S020) | Cordis US Corporation | 2009-11-20 |
| FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S020) | Abbott Laboratories | 2009-11-20 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S018) | W. L. Gore & Associates, Inc. | 2009-11-20 |
| SAFIRE CARDIAC ABLATION SYSTEM (P960016/S025) | St Jude Medical | 2009-11-20 |