| SYNVISC-ONE (HYLAN G-F 20) (P940015/S017) | Sanofi Genzyme Corp. | 2010-03-12 |
| COGNIS (P010012/S233) | Boston Scientific Corp | 2010-03-12 |
| UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (P970034/S014) | Aaren Scientific | 2010-03-12 |
| SECURA DR/VR/ MAXIMO II DR/VR/VIRTUOSO II DR/VR (P980016/S227) | Medtronic Cardiac Rhythm Disease Management | 2010-03-12 |
| CELSIUS/EZ STEER (P950005/S029) | Biosense Webster, Inc. | 2010-03-12 |
| RADIESSE INJECTABLE IMPLANT (P050052/S025) | Merz North America, Inc. | 2010-03-12 |
| SETROX S & DEXTRUS LEADS (P950037/S077) | Biotronik, Inc. | 2010-03-12 |
| TELIGEN (P960040/S213) | Boston Scientific | 2010-03-12 |
| OVATIO VR 6250 & OVATIO DR 6550 (P980049/S054) | MicroPort CRM USA, Inc. | 2010-03-12 |
| NAVISTAR THERMOCOOL (P040036/S020) | Biosense Webster, Inc. | 2010-03-12 |
| LINOX SD & LINOX S (P980023/S039) | Biotronik, Inc. | 2010-03-12 |
| VISTAKON (SENOFILCON A) CONTACT LENSES (P040045/S011) | Vistakon, Division of Johnson & Johnson Vision Car | 2010-03-12 |
| RADIESSE INJECTABLE IMPLANT (P050037/S022) | Merz North America, Inc. | 2010-03-12 |
| OVATIO CRT 6750 (P060027/S021) | MicroPort CRM USA, Inc. | 2010-03-12 |
| ANTERIOR CHAMBER INTRAOCULAR LENS (P010027/S003) | Aaren Scientific | 2010-03-12 |
| NAVISTAR/EZ STEER NAV/QWIKSTAR (P990025/S024) | Biosense Webster, Inc. | 2010-03-12 |
| PREPSTAIN INSTRUMENT (P970018/S019) | Bd Diagnostic Systems | 2010-03-11 |
| COAPTITE INJECTABLE IMPLANT (P040047/S016) | Merz North America, Inc. | 2010-03-11 |
| PARADIGM REAL-TIME INSULIN INFUSINO PUMPS (P980022/S031) | Medtronic Minimed | 2010-03-10 |
| BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S015) | Smith & Nephew, Inc. | 2010-03-09 |
| STAR S4 & STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) (P930016/S032) | Amo Manufacturing USA, LLC | 2010-03-09 |
| BD PREPSTAIN SYSTEM (P970018/S020) | Bd Diagnostic Systems | 2010-03-08 |
| COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST (P000012/S023) | Roche Molecular Systems, Inc. | 2010-03-08 |
| HERCEPTEST (P980018/S008) | Agilent Technologies Singapore (International) Pte , Ltd. | 2010-03-08 |
| ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II/SECURA/VIRTUOSO/VIRTUOSO II ICDS (P980016/S225) | Medtronic Cardiac Rhythm Disease Management | 2010-03-05 |
| EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003) | Boston Scientific Corporation | 2010-03-05 |
| SYNCHROMED INFUSION SYSTEM (P860004/S122) | Medtronic, Inc. | 2010-03-05 |
| INSYNC II PROTECT/SENTRY/MARQUIS/MAXIMO ICDS/CONCERTO/CONSULTA/MAXIMO II/CONCERTO II CRT-DS (P010031/S185) | Medtronic Cardiac Rhythm Disease Management | 2010-03-05 |
| CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS MODELS 7000, 7000TFX AND MODELS 7200TFX (P860057/S065) | Edwards Lifesciences, LLC | 2010-03-05 |
| MEDTRONIC SYNCHROMEDPUMP AND INFUSION SYSTEM (P860004/S118) | Medtronic, Inc. | 2010-03-05 |
| MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO ICDS/SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II VR/DR (P980016/S226) | Medtronic Cardiac Rhythm Disease Management | 2010-03-05 |
| CADENCE FAMILY OF ICDS (P910023/S230) | ABBOTT MEDICAL | 2010-03-05 |
| AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S185) | ABBOTT MEDICAL | 2010-03-05 |
| LUMAX FAMILIES OF ICDS & CRT-DS (P050023/S027) | Biotronik, Inc. | 2010-03-05 |
| CONCERTO/II/CONSULTA/INSYNC II/III MARQUIS/INSYNC MAXIMO/INSYNC SENTRY/MAXIMO II CRT-DS (P010031/S184) | Medtronic Cardiac Rhythm Disease Management | 2010-03-05 |
| SCULPTRA AESTHETIC (P030050/S005) | Q-Med AB | 2010-03-05 |
| EPIC HF/ATLAS+ HF FAMILY OF CRT-DS (P030054/S145) | ABBOTT MEDICAL | 2010-03-05 |
| FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S066) | ABBOTT MEDICAL | 2010-03-05 |
| NAVISTAR THERMOCOOL/NAVISTAR RMT THERMOCOOL/ EZ STEER THERMOCOOL NAV (P040036/S019) | Biosense Webster, Inc. | 2010-03-04 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S032) | Abbott Vascular, Inc. | 2010-03-04 |
| NAVISTAR THERMOCOOL/NAVISTAR RMT THERMOCOOL/ EZ STEER THERMOCOOL NAV (P030031/S026) | Biosense Webster, Inc. | 2010-03-04 |
| ISOMED PUMP AND INFUSION SYSTEM (P990034/S015) | Medtronic, Inc. | 2010-03-04 |
| NAVISTAR/NAVISTAR RMT/EZ STEER NAV/QWIKSTAR (P990025/S023) | Biosense Webster, Inc. | 2010-03-04 |
| SELENIA FFDM SYSTEM FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P010025/S018) | Hologic, Inc. | 2010-03-04 |
| VIGOR FAMILY (P940031/S066) | Boston Scientific | 2010-03-04 |
| DEEP BRAIN STIMULATION THERAPY (P960009/S075) | Medtronic, Inc. | 2010-03-04 |
| RENEWAL 3 RF/LIVIAN/COGNIS (P010012/S235) | Boston Scientific Corp | 2010-03-04 |
| VENTAK FAMILY (P960040/S217) | Boston Scientific | 2010-03-04 |
| SPINAL CORD STIMULATION THERAPY (P840001/S143) | Medtronic Neuromodulation | 2010-03-04 |
| SYNCHROMED PUMP AND INFUSION SYSTEM (P860004/S117) | Medtronic, Inc. | 2010-03-04 |
| PARADYM CRT-D (P060027/S020) | MicroPort CRM USA, Inc. | 2010-03-04 |
| TELIGEN/CONFIENT (P960040/S215) | Boston Scientific | 2010-03-04 |
| CONTAK RENEWAL TR FAMILY (P030005/S061) | Guidant Corp. | 2010-03-04 |
| T-SPOT TB TEST (P070006/S003) | Oxford Immunotec, Ltd. | 2010-03-04 |
| NAVISTAR DS/NAVISTAR RMT DS/EZ STEER NAV DS/QWIKSTAR DS (P010068/S019) | Biosense Webster, Inc. | 2010-03-04 |
| CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM (P910023/S224) | ABBOTT MEDICAL | 2010-03-03 |
| CADENCE ICD SYSTEM (P910023/S223) | ABBOTT MEDICAL | 2010-03-03 |
| INTERSTIM SACRAL NERVE STIMULATION (SNS) THERAPY FOR URINARY CONTROL (P970004/S081) | Medtronic Neuromodulation | 2010-03-03 |
| SYNCHROMED PUMP AND INFUSION SYSTEM (P860004/S121) | Medtronic, Inc. | 2010-03-03 |
| EPIC HF CRT-D SYSTEM (P030054/S139) | ABBOTT MEDICAL | 2010-03-03 |
| DEEP BRAIN STIMULATION (DBS) (P960009/S078) | Medtronic, Inc. | 2010-03-03 |
| INTERSTIM SACRAL NERVE STIMULATION (SNS) THERAPY (P970004/S077) | Medtronic Neuromodulation | 2010-03-03 |
| SPINAL CORD STIMULATION (SCS) (P840001/S147) | Medtronic Neuromodulation | 2010-03-03 |
| OCTAPOLAR EXTENSION/SPECIFY SURGICAL LEAD KIT (P840001/S148) | Medtronic Neuromodulation | 2010-03-03 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S007) | Boston Scientific Corp | 2010-03-01 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S043) | Boston Scientific Corp | 2010-03-01 |
| EXPRESS/EXPRESS2 CORONARY STENT SYSTEM (P020009/S060) | Boston Scientific Scimed, Inc. | 2010-03-01 |
| VERIFLEX (LIBERTE) BARE METAL CORONARY STENT SYSTEM (P040016/S053) | Boston Scientific Scimed, Inc. | 2010-03-01 |
| PTCA CATHETERS (P860019/S250) | Scimed Life Systems, Inc. | 2010-03-01 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S083) | Boston Scientific Corp | 2010-03-01 |
| ITREL 3/SYNERGY/RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P840001/S146) | Medtronic Neuromodulation | 2010-02-26 |
| SYNCHROMED II & ISOMED IMPLANTABLE INFUSION PUMPS (P990034/S016) | Medtronic, Inc. | 2010-02-26 |
| SOLETRA/KINETRA IMPLANTABLE NEUROSTIMULATORS/ACTIVA PC & RC (P960009/S077) | Medtronic, Inc. | 2010-02-26 |
| SYNCHROMED II & ISOMED IMPLANTABLE INFUSION PUMPS (P860004/S120) | Medtronic, Inc. | 2010-02-26 |
| SYNCHROMED II PUMP/INTRATHECAL CATHETERS/INTRATHECAL CATHETERS/PUMP/SPINAL SEGMENT REVISION KITS/SUTURELESS PUMP (P860004/S119) | Medtronic, Inc. | 2010-02-26 |
| INTERSTIM/INTERSTIM II IMPLANTABLE NEUROSTIMULATORS (P970004/S080) | Medtronic Neuromodulation | 2010-02-26 |
| ABBOTT AFP-EIA (P820060/S024) | Abbott Laboratories | 2010-02-26 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S048) | Medtronic, Inc. | 2010-02-26 |
| FLOSEAL HEMOSTATIC MATRIX (P990009/S028) | Baxter Healthcare Corp | 2010-02-26 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S051) | Boston Scientific Scimed, Inc. | 2010-02-25 |
| SIEMENS IMMULITE PSA AND THIRD GENERATION PSA ASSAYS ON THE IMMULITE, IMMULITE 1000, 2000 AND IMMULITE 2500 ANALYZERS (P930027/S008) | Siemens Healthcare Diagnostics, Inc. | 2010-02-25 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S041) | Boston Scientific Corp | 2010-02-25 |
| HERCEP TEST (P980018/S006) | Agilent Technologies Singapore (International) Pte , Ltd. | 2010-02-25 |
| TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM (P990040/S009) | Cerenovus, Inc. | 2010-02-25 |
| FLEXTOME CUTTING BALLOON (P950020/S037) | Boston Scientific Corp | 2010-02-25 |
| HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM (P000032/S035) | CooperSurgical, Inc. | 2010-02-25 |
| MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS (P990018/S004) | Menicon Co, Ltd. | 2010-02-25 |
| MAVERICK2 PTCA CATHETER/APEX PTCA CATHETER (P860019/S248) | Scimed Life Systems, Inc. | 2010-02-25 |
| FALOPE-RING BAND AND APPLICATOR SYSTEMS (P870076/S009) | Gyrus Acmi, Inc. | 2010-02-25 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROTHESIS MODELS 2700/TFX/2800/TFX/3000/TFX/3300TFX/6900/P/PTFX/7000/TFX (P860057/S067) | Edwards Lifesciences, LLC | 2010-02-24 |
| HYLAFORM FAMILY DERMAL FILLERS (HYLAFORM, HYLAFORM PLUS AND CAPTIQUE INJECTABLE GEL) (P030032/S008) | Genzyme Biosurgery | 2010-02-24 |
| CARPENTIER-EDWARDS PORCINE BIOPROSTHESIS MODELS 2625/6625 (P870056/S039) | Edwards Lifesciences, LLC | 2010-02-24 |
| CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS MODEL 2650 (P010041/S024) | Edwards Lifesciences, LLC | 2010-02-24 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS MODELS 6625LP/6625-ESR-LP (P870077/S036) | Edwards Lifesciences, LLC | 2010-02-24 |
| DEFLUX INJECTABLE GEL (P000029/S063) | Palette Life Sciences | 2010-02-23 |
| DEFLUX INJECTABLE GEL (P000029/S062) | Palette Life Sciences | 2010-02-23 |
| VISTAKON (SENOFILCON A) CONTACT LENSES (P040045/S010) | Vistakon, Division of Johnson & Johnson Vision Car | 2010-02-23 |
| HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM (P000032/S034) | CooperSurgical, Inc. | 2010-02-23 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEMS (P030025/S082) | Boston Scientific Corp | 2010-02-22 |
| PRECISION SPINAL CORD STIMULATOR SYSTEM (P030017/S099) | Boston Scientific Corp | 2010-02-22 |