| ACTIVA THERAPY FOR DBS (P960009/S057) | Medtronic, Inc. | 2009-01-16 |
| TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) (P080010) | Johnson & Johnson Surgical Vision, Inc. | 2009-01-16 |
| CYPHER SIROLIMUS-ELUTING CORONARY ON RAPTOR OVER-THE-WIRE DELIVERY SYSTEM /RAPTORAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S060) | Cordis Corp. | 2009-01-16 |
| ST JUDE MEDICAL FRONTIER/FRONTIER II CRT-PS (P030035/S050) | ABBOTT MEDICAL | 2009-01-16 |
| TALENT ABDOMINAL STENT GRAFT SYSTEM (P070027/S005) | Medtronic Vascular | 2009-01-16 |
| SYNCHROMED II IMPLANTABLE INFUSION PUMP MODEL 8637 (P860004/S094) | Medtronic, Inc. | 2009-01-16 |
| UVAR XTS PHOTOPHERESIS SYSTEM (P860003/S051) | Therakos Development Limited | 2009-01-16 |
| LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM (P000008/S014) | Medtimo, Inc. | 2009-01-16 |
| CADENCE FAMILY OF ICDS (P910023/S198) | ABBOTT MEDICAL | 2009-01-15 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S028) | ABBOTT MEDICAL | 2009-01-15 |
| FRONTIER/FRONTIER II FAMILY OF CRT-P (P030035/S046) | ABBOTT MEDICAL | 2009-01-15 |
| EPIC HF/ATLAS + HF FAMILY OF CRT-DS (P030054/S112) | ABBOTT MEDICAL | 2009-01-15 |
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S061) | St. Jude Medical, Inc. | 2009-01-15 |
| AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S173) | ABBOTT MEDICAL | 2009-01-15 |
| AFFINTY/IDENTITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S167) | ABBOTT MEDICAL | 2009-01-15 |
| FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S052) | ABBOTT MEDICAL | 2009-01-15 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATOR (P000044/S019) | Ortho-Clinical Diagnostics, Inc. | 2009-01-14 |
| INSYNC CRT-P (P010015/S060) | Medtronic, Inc. | 2009-01-14 |
| VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR (P030024/S009) | Ortho-Clinical Diagnostics | 2009-01-14 |
| STAAR SURGICAL COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (P990013/S024) | Starr Surgical Co. | 2009-01-14 |
| FLEXTOME CORONARY CUTTING BALLOON (P950020/S031) | Boston Scientific Corp | 2009-01-14 |
| X-STOP IPD SYSTEM (P040001/S011) | Medtronic Sofamor Danek, Inc. | 2009-01-14 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTALINK EXCHANGABLE CATHETER (P900056/S094) | Boston Scientific Corp | 2009-01-14 |
| RESTORE FAMILY OF NEUROSTIMULATOR SYSTEMS (P840001/S124) | Medtronic Neuromodulation | 2009-01-14 |
| STAAR SURGICAL COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER (P030016/S011) | STAAR Surgical Company | 2009-01-14 |
| COBAS AMPLICOR HCV TEST, VERSION 2.0 (P000012/S020) | Roche Molecular Systems, Inc. | 2009-01-14 |
| PRODIGY IPG (P890003/S161) | Medtronic, Inc. | 2009-01-14 |
| KAPPA 400 DR/SR IPG (P970012/S050) | Medtronic, Inc. | 2009-01-14 |
| VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR (P030026/S015) | Ortho-Clinical Diagnostics, Inc. | 2009-01-14 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE) (P060008/S009) | Boston Scientific Corp | 2009-01-14 |
| TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P960040/S186) | Boston Scientific | 2009-01-14 |
| AMPLICOR HCV TEST VERSION 2.0 (P000010/S013) | Roche Molecular Systems, Inc. | 2009-01-14 |
| GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATATION CATHETERS (P790017/S099) | Medtronic, Ireland | 2009-01-14 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR (P000014/S017) | Ortho-Clinical Diagnostics, Inc. | 2009-01-14 |
| C/T SERIES/SELECTION/DIAMOND II/JADE II/RUBY II/TOPAZ II/VITA/VITA II/DEMA FAMILY OF IPG (P990001/S049) | Medtronic, Inc. | 2009-01-14 |
| COGNIS CARDIAC RESYNCHRONIZATION HE DEFIBRILLATOR (P010012/S199) | Boston Scientific Corp | 2009-01-14 |
| INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM (P970004/S066) | Medtronic Neuromodulation | 2009-01-14 |
| KAPPA 600/700/650/800/900/SIGMA/MEDTRONIC 350 IPG/ENPULSE/ADAPTA/VERSIA/SENSIA/RELIA FAMILIES OF IPG (P980035/S126) | Medtronic, Inc. | 2009-01-14 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATOR (P010021/S014) | Ortho-Clinical Diagnostics, Inc. | 2009-01-14 |
| ACTIVA THERAPY FOR DBS (P960009/S058) | Medtronic, Inc. | 2009-01-14 |
| GYNECARE THERMACHOICE II (P970021/S024) | Gynecare, Inc. | 2009-01-14 |
| SYNCHROMED PUMP AND INFUSION SYSTEM (P860004/S103) | Medtronic, Inc. | 2009-01-14 |
| PROMOTE CRT-D SYSTEM (P910023/S154) | ABBOTT MEDICAL | 2009-01-13 |
| RIATA ST OPTIM AND RIATA STS OPTIM (P950022/S042) | ABBOTT MEDICAL | 2009-01-13 |
| ATLAS II + HF CRT-D SYSTEM (P030054/S067) | ABBOTT MEDICAL | 2009-01-13 |
| BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S008) | Smith & Nephew, Inc. | 2009-01-12 |
| DRIVER & MICRO-DRIVER CORONARY STENT SYSTEMS (P030009/S031) | Medtronic, Ireland | 2009-01-10 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S009) | W. L. Gore & Associates, Inc. | 2009-01-10 |
| ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S028) | Medtronic, Inc. | 2009-01-10 |
| ENDEAVOR/ENDEAVOR SPRINT ZOTAROLIMU-ELUTING CORONARY STENT SYSTEM (P060033/S027) | Medtronic, Inc. | 2009-01-10 |
| S-SERIES LAMITRODES (P010032/S027) | ABBOTT MEDICAL | 2009-01-10 |
| VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT SYSTEM (P990052/S020) | Med-El Elektromedizinische Gerate GmbH | 2009-01-09 |
| STAAR SURGICAL ELASTIC/ELASTIMIDE/ELASTIC TORIC/ASPHERIC ELASTIMIDE ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR (P880091/S029) | Staar Surgical Co. | 2009-01-09 |
| KAPPA 400 DR/SR IPG (P970012/S049) | Medtronic, Inc. | 2009-01-09 |
| DEFLUX INJECTABLE GEL (P000029/S053) | Palette Life Sciences | 2009-01-09 |
| ATTAIN STARFIX LEAD (P060039/S005) | Medtronic, Inc. | 2009-01-09 |
| CAPSURE SP NOVUS/SP LEADS/CAPSURE SENSE LEADS (P830061/S044) | Medtronic Cardiac Rhythm Disease Management | 2009-01-09 |
| BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR (P990019/S006) | Sun Pharmaceutical Industries, Inc. | 2009-01-09 |
| CS-SVC TRANSVENE LEAD (P980050/S039) | Medtronic, Inc. | 2009-01-09 |
| CAPSUREFIX NOVUS/SUREFIX/CAPSUREFIX LEADS (P930039/S029) | Medtronic, Inc. | 2009-01-09 |
| SELECTSECURE LEAD (P030036/S011) | Medtronic Cardiac Rhythm Disease Management | 2009-01-09 |
| FUJI COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE (P050014/S001) | Fujifilm Medical System U.S.A., Inc. | 2009-01-09 |
| INSYNC/INSYNC MARQUIS& MARQUIS II/III/INSYNC II/III PROTECT/INSYNC SENTRY/MAXIMO/MAXIMO II CRT-D/CONCERTO CRT-D/CONSULTA (P010031/S138) | Medtronic Cardiac Rhythm Disease Management | 2009-01-09 |
| WRENCH KIT/SERVICE KIT/CAPSURE VDD LEADS (P890003/S160) | Medtronic, Inc. | 2009-01-09 |
| PRODIGY IPG (P890003/S159) | Medtronic, Inc. | 2009-01-09 |
| INSYNC CARDIAC RESYNCHRONIZATION THERAPY PACING (CRT-P) & INSYNC III CRT-P (P010015/S058) | Medtronic, Inc. | 2009-01-09 |
| CAPSURE FIX LEAD (P980016/S172) | Medtronic Cardiac Rhythm Disease Management | 2009-01-09 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S014) | W. L. Gore & Associates, Inc. | 2009-01-09 |
| CAPSURE EPI UNIPOLAR/BIPOLAR LEADS (P950024/S015) | Medtronic, Inc. | 2009-01-09 |
| PRODIGY IPG/KAPPA 400DR/SR/KAPPA 600/700/650/800/900/SIGMA/MEDTRONIC 350/RELIA/ENPULSE II/AT500/ADAPTA/VERSA/SENSIA (P980035/S125) | Medtronic, Inc. | 2009-01-09 |
| DEMA FAMILY/C-SERIES/T-SERIES (P990001/S048) | Medtronic, Inc. | 2009-01-09 |
| ATTAIN SD (P010031/S139) | Medtronic Cardiac Rhythm Disease Management | 2009-01-09 |
| EPICARDIAL TRANSVENE/CABLE/ACE HEADER/UPSIZING SLEEVE FOR HV LEAD DF-1/UPSIZING SLEEVE/LEAD END PIN CAP (P900061/S081) | Medtronic Cardiac Rhythm Disease Management | 2009-01-09 |
| CAPSURE Z NOVUS/CAPSURE Z/CAPSURE SP/ CAPSURE SP NOVUS LEADS (P850089/S060) | Medtronic Cardiac Rhythm Disease Management | 2009-01-09 |
| LEAD/Y ADAPTORS/IS-1 PORT PIN PLUG/SPRINT LEAD/QUATTRO/QUATTRO SECURE/QUATTRO SINGLE COIL/TRANSVENE SVC/DF-1/Y ADAPTOR (P920015/S051) | Medtronic, Inc. | 2009-01-09 |
| MARQUIS ICD/MAXIMO/MAXIMO II/INTRINSIC/ENTRUST/VIRTUOSO/SECURA ICD FAMILIES (P980016/S171) | Medtronic Cardiac Rhythm Disease Management | 2009-01-09 |
| ATTAIN OTW/BIPOLAR OTW/CS/LV LEADS (P010015/S059) | Medtronic, Inc. | 2009-01-09 |
| FEMCARE FILSHIE CLIP (P920046/S007) | Femcare , Ltd. | 2009-01-08 |
| MYNX VASCULAR CLOSURE DEVICE (P040044/S010) | Cordis US Corporation | 2009-01-08 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S007) | ABBOTT MEDICAL | 2009-01-08 |
| HEARTMATE II LVAS (P060040/S003) | ABBOTT MEDICAL | 2009-01-08 |
| ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S021) | Medtronic, Inc. | 2009-01-08 |
| AMPLATZER SEPTAL OCCLUDER, AND AMPLATZER ¿CRIBRIFORM¿ OCCLUDER (P000039/S027) | ABBOTT MEDICAL | 2009-01-08 |
| COAPTITE INJECTABLE IMPLANT (P040047/S012) | Merz North America, Inc. | 2009-01-07 |
| RADIESSE INJECTABLE IMPLANT (P050037/S016) | Merz North America, Inc. | 2009-01-06 |
| RADIESSE INJECTABLE IMPLANT (P050052/S017) | Merz North America, Inc. | 2009-01-06 |
| VARIOUS FAMILIS OF ICDS (P980016/S140) | Medtronic Cardiac Rhythm Disease Management | 2009-01-06 |
| INSYNC FAMILIES OF ICD & CONCERTO ICD & CONSULTA CRT-D & MAXIMO II CRT-D (P010031/S109) | Medtronic Cardiac Rhythm Disease Management | 2009-01-06 |
| ACTIVA THERAPY FOR DBS (P960009/S059) | Medtronic, Inc. | 2009-01-05 |
| ITREL/SYNERGY/RESTORE FAMILY OF NEUROSTIMULATOR SYSTEMS (P840001/S125) | Medtronic Neuromodulation | 2009-01-05 |
| INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM (P970004/S067) | Medtronic Neuromodulation | 2009-01-05 |
| LINOX SD 60/16 STEROID-ELUTING, ACTIVE FIXATION ICD LEAD (P980023/S037) | Biotronik, Inc. | 2009-01-05 |