| WALLSTENT VENOUS ENDOPROSTHESIS (P980033/S016) | Boston Scientific Corporation | 2010-02-22 |
| BLAZER PRIME/BLAZER II/BLAZER XP/BLAZER HTD TEMPERATURE ABLATION CATHETERS (P920047/S041) | Boston Scientific Corp | 2010-02-22 |
| EPT-1000 XP CARDIAC ABLATION SYSTEM CONTROLLER AND ACCESSORIES AND MAESTRO 3000 CARDIAC ABLATION SYSTEM AND ACCESSORIES (P020025/S022) | Boston Scientific | 2010-02-22 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S050) | Boston Scientific Scimed, Inc. | 2010-02-22 |
| WALLSTENT LLIAC ENDOPROSTHESIS (P940019/S022) | Boston Scientific Scimed, Inc. | 2010-02-22 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S042) | Boston Scientific Corp | 2010-02-22 |
| VIRTUOSO ICD (P980016/S224) | Medtronic Cardiac Rhythm Disease Management | 2010-02-22 |
| WALLSTENT TIPS ENDOPROSTHESIS (P930031/S027) | Boston Scientific Corp | 2010-02-22 |
| CHILI/CHILI II COOLED ABLATION SYSTEM AND CATHETER (P980003/S022) | Boston Scientific Corp | 2010-02-22 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S040) | Boston Scientific Corp | 2010-02-22 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S005) | Boston Scientific Corp | 2010-02-22 |
| PTCA CATHETERS (P860019/S249) | Scimed Life Systems, Inc. | 2010-02-22 |
| FLEXTOME CUTTING BALLOON DILATATIONS DEVICE (P950020/S038) | Boston Scientific Corp | 2010-02-22 |
| CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S003) | Boston Scientific Corp | 2010-02-22 |
| VERIFLEX (LIBERTE) BARE METAL CORONARY STENT SYSTEM (P040016/S052) | Boston Scientific Scimed, Inc. | 2010-02-22 |
| CONCERTO CRT-D (P010031/S183) | Medtronic Cardiac Rhythm Disease Management | 2010-02-22 |
| ROTABLATOR ATHERECTOMY DEVICES (P900056/S097) | Boston Scientific Corp | 2010-02-22 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S061) | Terumo Medical Corporation | 2010-02-22 |
| EXPRESS2 CORONARY STENT SYSTEMS (P020009/S058) | Boston Scientific Scimed, Inc. | 2010-02-22 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S059) | Boston Scientific Scimed, Inc. | 2010-02-22 |
| KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENSIA IPGS (P980035/S157) | Medtronic, Inc. | 2010-02-19 |
| INSYNC/INSYNC MARQUIS/II/III/INSYNC II PROTECT/III/INSYNC SENTRY/INSYNC MAXIMO ICDS/CONCERTO/II/MAXIMO/CONSULTA CRT-DS (P010031/S182) | Medtronic Cardiac Rhythm Disease Management | 2010-02-19 |
| VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES/CLEAR & TINTED (VISIBILITY AND COSMETICALLY) WITH UV BLOCKER (N18033/S042) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2010-02-19 |
| GEM II/MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR ICDS (P980016/S223) | Medtronic Cardiac Rhythm Disease Management | 2010-02-19 |
| ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS (P010062/S007) | Bausch & Lomb | 2010-02-19 |
| INSYNC CRT-P/INSYNC III CRT-P (P010015/S078) | Medtronic, Inc. | 2010-02-19 |
| VISTAKON (SENOFILCON A) CONTACT LENSES CLEAR/VISIBILITY TINTED WITH UV BLOCKER (P040045/S007) | Vistakon, Division of Johnson & Johnson Vision Car | 2010-02-19 |
| PRODIGY/THERA I IPG (P890003/S185) | Medtronic, Inc. | 2010-02-19 |
| KAPPA 400 DR/SR IPG (P970012/S063) | Medtronic, Inc. | 2010-02-19 |
| EPICARDIAL PATCH LEAD & SIZING/UPSIZING SLEEVE (P900061/S086) | Medtronic Cardiac Rhythm Disease Management | 2010-02-18 |
| INSYNC ICD/MARQUIS/II MARQUIS/III MARQUIS/II PROTECT/III PROTECT/SENTRY/MAXIMOICDS/CONCERTO/II/MAXIMO II/CONSULTA CRT-DS (P010031/S180) | Medtronic Cardiac Rhythm Disease Management | 2010-02-18 |
| CAPSUREFIX LEAD/MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO FAMILY OF ICDS (P980016/S222) | Medtronic Cardiac Rhythm Disease Management | 2010-02-18 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES MODELS 2700/2700TFX/2800/2800TFX/3000/3000TFX/3300TFX/6900P/PTFX (P860057/S066) | Edwards Lifesciences, LLC | 2010-02-18 |
| MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR (P980016/S220) | Medtronic Cardiac Rhythm Disease Management | 2010-02-18 |
| CARPENTIER-EDWARDS DURAFLEX MITRAL LOW PRESSURE BIOPROSTHESIS MODELS 6625L/6625-ESR-LP (P870077/S035) | Edwards Lifesciences, LLC | 2010-02-18 |
| CAPSURE SP NOVUS LEADS/CAPSURE LEADS/CAPSURE SP LEADS/CAPSURE SENSE/EXCELLENCE PS +/EXCELLENCE + (P830061/S049) | Medtronic Cardiac Rhythm Disease Management | 2010-02-18 |
| KAPPA 400 DR/SR IPG (P970012/S062) | Medtronic, Inc. | 2010-02-18 |
| ATTAIN OTW/ATTAIN LV LEAD/ATTAIN CS LEAD (P010015/S077) | Medtronic, Inc. | 2010-02-18 |
| ATTAIN SD LH LEAD/INSYNC SENTRY/INSYNC MAXIMO (P010031/S181) | Medtronic Cardiac Rhythm Disease Management | 2010-02-18 |
| CSS-SVC TRANSVENE LEAD (P980050/S046) | Medtronic, Inc. | 2010-02-18 |
| DEMA IPG/C-SERIES IPG/T-SERIES IPG (P990001/S060) | Medtronic, Inc. | 2010-02-18 |
| ACRYSOF & ACRYSOF RESTOR INTRAOCULAR LENSES (P930014/S038) | Alcon Laboratories, Inc. | 2010-02-18 |
| SELECTSECURE LEAD (P030036/S015) | Medtronic Cardiac Rhythm Disease Management | 2010-02-18 |
| BIOFINITY (COMFILCON A) SOFT CONTACT LENS FOR EXTENDED WEAR (P080011/S002) | CooperVision, Inc. | 2010-02-18 |
| SUREFIX LEAD/CAPSUREFIX LEAD/CAPSUREFIX NOVUS/PIROUET (P930039/S035) | Medtronic, Inc. | 2010-02-18 |
| CAPSURE VDD LEADS/VITATRON LEGACY DR/D/II/VISA/CAPSURE LEAD/BRILLIANT S+VDD (P890003/S184) | Medtronic, Inc. | 2010-02-18 |
| KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENSIA IPGS (P980035/S156) | Medtronic, Inc. | 2010-02-18 |
| CARPENTIER EDWARDS PORCINE BIOPROSTHESIS MODELS 2625/6625 (P870056/S038) | Edwards Lifesciences, LLC | 2010-02-18 |
| INSYNC CRT-P/INSYNC III CRT-P (P010015/S076) | Medtronic, Inc. | 2010-02-18 |
| ATTAIN STARFIX LEAD (P060039/S009) | Medtronic, Inc. | 2010-02-18 |
| ACRYSOF AND ACRYSOF RESTOR INTRAOCULAR LENSES (P040020/S023) | Alcon Research, Ltd. | 2010-02-18 |
| AMS MODEL 800 ARTIFICIAL URINARY SPHINCTER (P000053/S027) | Boston Scientific Corp | 2010-02-18 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P (P000007/S024) | Edwards Lifesciences, LLC | 2010-02-18 |
| PRODIGY/THERA I IPG (P890003/S182) | Medtronic, Inc. | 2010-02-18 |
| CARPENTIER EDWARDS S.A.V. BIOPROSTHESIS MODEL 2650 (P010041/S023) | Edwards Lifesciences, LLC | 2010-02-18 |
| CAPSURE EPI UNIPOLAR & BIPOLAR LEAD (P950024/S019) | Medtronic, Inc. | 2010-02-18 |
| CAPSURE Z/NOVUS LEADS/ CAPSURE SP/NOVUS LEADS/EXCELLENCE S+/IMPULSE/VITATRON IMPULSE II (P850089/S064) | Medtronic Cardiac Rhythm Disease Management | 2010-02-18 |
| SPRINT/SPRINT QUATTRO/SPRINT QUATTRO SECURE LEAD/TRANSVENE SVC/DF-1 LEADS/SPRINT QUATTRO SINGLE COIL/END CAP ACCESSORY (P920015/S058) | Medtronic, Inc. | 2010-02-18 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S054) | Cochlear Americas | 2010-02-17 |
| CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S030) | Bayer Pharma AG | 2010-02-15 |
| ITREL III IMPLANTABLE NEUROSTIMULATORS (P840001/S145) | Medtronic Neuromodulation | 2010-02-12 |
| PROLIEVE THERMODILITATION SYSTEM (P030006/S023) | Medifocus, Inc. | 2010-02-12 |
| INTERSTIM IMPLANTABLE NEUROSTIMULATORS (P970004/S078) | Medtronic Neuromodulation | 2010-02-12 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S034) | W. L. Gore & Associates, Inc. | 2010-02-12 |
| OPTIVISC (P000046/S016) | Anika Therapeutics, Inc. | 2010-02-12 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S028) | Medtronic, Inc. | 2010-02-05 |
| PARADYM CRT-D (P060027/S017) | MicroPort CRM USA, Inc. | 2010-02-05 |
| CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO (P010031/S179) | Medtronic Cardiac Rhythm Disease Management | 2010-02-05 |
| HANCOCK STANDARD PORCINE BIOPROSTHESIS (P870078/S007) | Medtronic, Inc. | 2010-02-05 |
| MOSAIC PORCINE BIOPROSTHESIS (P990064/S031) | Medtronic, Inc. | 2010-02-05 |
| SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO (P980016/S219) | Medtronic Cardiac Rhythm Disease Management | 2010-02-05 |
| SYMPHONY & RHAPSODY SR/REPLY SR/DR/REPLY SR/DR (V2)/ESPRIT SR/DR (P950029/S050) | MicroPort CRM USA, Inc. | 2010-02-05 |
| HANCOCK II PORCINE BIOPROSTHESIS (P980043/S024) | Medtronic, Inc. | 2010-02-05 |
| TALENT ABDOMINAL STENT GRAFT SYSTEM (P070027/S011) | Medtronic Vascular | 2010-02-04 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S008) | Roche Molecular Systems, Inc. | 2010-02-04 |
| SURGICEL ORGINAL/SURGICEL FIBRILLAR/SURGICEL NU-KNIT ABSORABLE HEMOSTATS (N12159/S025) | ETHICON, Inc. | 2010-02-04 |
| VOYAGER NC CORONARY DILATATION CATHETER (P810046/S232) | Advanced Cardiovascular Systems, Inc. | 2010-02-04 |
| LCS TOTAL KNEE SYSTEM (P830055/S114) | Depuy, Inc. | 2010-02-04 |
| COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM (P050028/S007) | Roche Molecular Systems, Inc. | 2010-02-04 |
| MICRONY PACEMAKERS (P970013/S032) | ABBOTT MEDICAL | 2010-02-03 |
| SENSOLOG/DIALOG/REGENCY PACEMAKERS (P880006/S065) | St. Jude Medical, Inc. | 2010-02-03 |
| EPIC HF/ATLAS/HF FAMILY OF CRT-DS (P030054/S137) | ABBOTT MEDICAL | 2010-02-03 |
| CADENCE FAMILY OF ICDS (P910023/S221) | ABBOTT MEDICAL | 2010-02-03 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S039) | Boston Scientific Corp | 2010-02-03 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S049) | Boston Scientific Scimed, Inc. | 2010-02-03 |
| FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S062) | ABBOTT MEDICAL | 2010-02-03 |
| GORE EXCULDER AAA ENDOPROSTHESIS (P020004/S045) | W. L. Gore & Associates, Inc. | 2010-02-03 |
| AFFINITY/IDENTITY/VERITY/INTERGRITY/VICTORY & ZEPHYR PACEMAKERS (P880086/S181) | ABBOTT MEDICAL | 2010-02-03 |
| CONCERTO II/CONSULTA CRT-D/MAXIMO II CRT-D (P010031/S167) | Medtronic Cardiac Rhythm Disease Management | 2010-02-03 |
| VIRTUOSO II DR/VR/SECURA DR/VR/MAXIMO II VR/DR (P980016/S206) | Medtronic Cardiac Rhythm Disease Management | 2010-02-03 |
| ATTAIN STARFIX LEAD (P060039/S006) | Medtronic, Inc. | 2010-02-02 |
| COCHLEAR IMPLANT SYSTEM (P970051/S050) | Cochlear Americas | 2010-02-02 |
| FLOSEAL ENDOSCOPIC APPLICATOR (P990009/S027) | Baxter Healthcare Corp | 2010-02-02 |
| STAN S31 SYSTEM (P020001/S007) | Neoventa Medical AB | 2010-02-01 |
| MAVERICK OVER-THE WIRE PTCA CATHETER (P860019/S247) | Scimed Life Systems, Inc. | 2010-02-01 |
| APEX PTCA DILATION CATHETERS (P860019/S232) | Scimed Life Systems, Inc. | 2010-02-01 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S034) | Boston Scientific Corp | 2010-01-29 |
| VERIFLEX (LIBERTE) BARE METAL CORONARY STENT SYSTEM (P040016/S048) | Boston Scientific Scimed, Inc. | 2010-01-29 |
| CADENCE FAMILY OF ICDS (P910023/S215) | ABBOTT MEDICAL | 2010-01-29 |
| QUANTIFERON - TB GOLD AND TB GOLD IN-TUBE (P010033/S014) | Qiagen | 2010-01-29 |