| LIVEWIRE TC CARDIAC ABLATION SYSTEM (P960016/S028) | St Jude Medical | 2010-04-06 |
| COSEAL SURGICAL SEALANT & ACCESSORIES (P030039/S015) | Baxter Bio Science | 2010-04-05 |
| PARADIGM REAL-TIME INSULIN PUMP (P980022/S068) | Medtronic Minimed | 2010-04-05 |
| COGNIS PULSE GENERATORS - MODELS N118 & N119 (P010012/S234) | Boston Scientific Corp | 2010-04-02 |
| BD PREPSTAIN SYSTEM (P970018/S018) | Bd Diagnostic Systems | 2010-04-02 |
| TELIGEN PULSE GENERATORS (P960040/S214) | Boston Scientific | 2010-04-02 |
| ORTHOVITA'S VITAGEL SURGICAL HEMOSTAT (P050044/S013) | Stryker Corp. | 2010-04-02 |
| INTERSTIM THERAPY TINED LEADS, MODELS 3889 AND 3093 (P970004/S082) | Medtronic Neuromodulation | 2010-04-02 |
| PERFLUORON (P950018/S013) | Alcon Laboratories | 2010-04-02 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S028) | Abbott Vascular, Inc. | 2010-04-01 |
| AKREOS ADVANCED OPTICS ASPHERIC LENS AND AKROES AO MICRO INCISION LENS (P060022/S006) | Bausch & Lomb, Inc. | 2010-04-01 |
| LATITUDE¿ COMMUNICATOR RF (P910077/S103) | Boston Scientific | 2010-04-01 |
| TALENT THORACIC STENT GRAFT SYSTEM (P070007/S016) | Medtronic Vascular | 2010-04-01 |
| LOTRAFILCON SOFT CONTACT LENSES FOR EXTENDED WEAR (P010019/S013) | Alcon Laboratories, Inc. | 2010-04-01 |
| TALENT ABDOMINAL STENT GRAFT SYSTEM (P070027/S016) | Medtronic Vascular | 2010-04-01 |
| DRIVER & MICRO-DRIVER CORONARY STENT SYSTEMS (P030009/S040) | Medtronic, Ireland | 2010-03-31 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S050) | Medtronic, Inc. | 2010-03-31 |
| MEDTRONIC AT500 DDDRP PACING SYSTEM (P980035/S155) | Medtronic, Inc. | 2010-03-31 |
| MEDTRONIC AT500 DDDRP PACING SYSTEM (P980050/S044) | Medtronic, Inc. | 2010-03-31 |
| MYNX VASCULAR CLOSURE DEVICE (P040044/S028) | Cordis US Corporation | 2010-03-31 |
| RESTYLANE INJECTABLE GEL (P040024/S046) | Q-Med AB | 2010-03-31 |
| ZENITH FLEX ENDOVASCULAR GRAFT (P020018/S034) | Cook, Inc. | 2010-03-31 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S071) | Cordis Corp. | 2010-03-31 |
| DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST AND DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST (P890064/S021) | Qiagen Gaithersburg, Inc. | 2010-03-31 |
| UROLOGIX TARGIS SYSTEM (P970008/S047) | Urologix, LLC | 2010-03-31 |
| HARMONY HIRESOLUTION BIONIC EAR SYSTEM (P960058/S082) | Advanced Bionics | 2010-03-30 |
| TLC-2PLUS PORTABLE VAD DRIVER (P870072/S043) | Thoratec Laboratories Corp. | 2010-03-30 |
| OXFORD MENSICAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S026) | Biomet Manufacturing Corp | 2010-03-29 |
| ACRYSERT C DELIVERY SYSTEM (P930014/S039) | Alcon Laboratories, Inc. | 2010-03-29 |
| HYALGAN (P950027/S012) | Fidia Farmaceutici S.P.A. | 2010-03-28 |
| DERMAGRAFT (P000036/S007) | Shire Regenerative Medicine | 2010-03-26 |
| EXOGEN 4000+ (P900009/S032) | Bioventus, LLC | 2010-03-26 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S044) | Boston Scientific Corp | 2010-03-26 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S084) | Boston Scientific Corp | 2010-03-26 |
| VOYAGER NC CORONARY DILATATION CATHETER (P810046/S234) | Advanced Cardiovascular Systems, Inc. | 2010-03-26 |
| COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S044) | Med-El Corp. | 2010-03-26 |
| MMT-7002 & MMT-7003 GLUCOSE SENSORS (P980022/S070) | Medtronic Minimed | 2010-03-26 |
| FLOSEAL HEMOSTATIC MATRIX (P990009/S029) | Baxter Healthcare Corp | 2010-03-25 |
| CARPENTIER-EDWARDS PERIMOUNT BIOPROSTHESIS HEART VALVE (P860057/S063) | Edwards Lifesciences, LLC | 2010-03-25 |
| LOTRAFILCON SOFT CONTACT LENSES FOR EXTENDED WEAR (P010019/S014) | Alcon Laboratories, Inc. | 2010-03-24 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S009) | Roche Molecular Systems, Inc. | 2010-03-24 |
| 5F & 6/7F MYNX VASCULAR CLOSURE DEVICE (P040044/S027) | Cordis US Corporation | 2010-03-24 |
| COBAS AMPLICOR HCV TEST (P000012/S024) | Roche Molecular Systems, Inc. | 2010-03-24 |
| THERAPY DUAL 8/THERAPY 8MM THERMISTOR/SAFIRE TX ABLATION CATHETERS (P040042/S018) | Irvine Biomedical,Inc.(Ibi) | 2010-03-23 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S031) | W. L. Gore & Associates, Inc. | 2010-03-23 |
| PROCOL VASCULAR BIOPROSTHESIS (P020049/S002) | LeMaitre Vascular, Inc. | 2010-03-23 |
| THERAPY COOL PATH ABLATION CATHETER (P060019/S011) | Irvine Biomedical, Inc. | 2010-03-23 |
| THERAPY CARDIAC ABLATION CATHETER/THERAPY 4MM THERMISTOR/THERAPY BI-DIRECTIONAL CATHETERS (P040014/S013) | Irvine Biomedical, Inc. | 2010-03-23 |
| T-SPOT .TB TEST (P070006/S004) | Oxford Immunotec, Ltd. | 2010-03-19 |
| BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGM IN VITRO DIAGNOSTIC DEVICE (P970055/S008) | Diasorin | 2010-03-19 |
| MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR ICDS (P980016/S229) | Medtronic Cardiac Rhythm Disease Management | 2010-03-19 |
| INSYNC III MARQUIS/PROTECT/INSYNC SENTRY/MAXIMO ICD/CONCERTO/II/MAXIMO II/CONSULTA CRT-D (P010031/S188) | Medtronic Cardiac Rhythm Disease Management | 2010-03-19 |
| BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGG IN VITRO DIAGNOSTIC DEVICE (P970054/S008) | Diasorin | 2010-03-19 |
| TECNIS MULTIFOCAL ONE-PIECE INTRAOCULAR LENS (IOL) (P980040/S032) | Johnson & Johnson Surgical Vision, Inc. | 2010-03-19 |
| KAPPA 600/700/650/800/900/ RELIA/SIGMA/ENPULSE/ENRHYTHM/ADAPTA/VERSA/SENSIA IPGS (P980035/S159) | Medtronic, Inc. | 2010-03-19 |
| INSYNC III CRT-P (P010015/S080) | Medtronic, Inc. | 2010-03-19 |
| C & T SERIES IPGS (P990001/S062) | Medtronic, Inc. | 2010-03-19 |
| THINPREP PROCESSOR 2000/3000 (P950039/S021) | Hologic, Inc. | 2010-03-18 |
| INSYNC & INSYNC III CRT-P (P010015/S079) | Medtronic, Inc. | 2010-03-18 |
| DEFLUX INJECTABLE GEL (P000029/S064) | Palette Life Sciences | 2010-03-18 |
| GEM II/MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR (P980016/S228) | Medtronic Cardiac Rhythm Disease Management | 2010-03-18 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S074) | Cordis Corp. | 2010-03-18 |
| CORDIS CYPHER SIROLIMUS-ELUTING CORONARY STENT/RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY (P020026/S073) | Cordis Corp. | 2010-03-18 |
| DEMA IPG/C& T SERIES IPGS (P990001/S061) | Medtronic, Inc. | 2010-03-18 |
| KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENIA IPG (P980035/S158) | Medtronic, Inc. | 2010-03-18 |
| INSYNC/INSYNC MARQUIS/INSYNC II/III MARQUIS/INSYNC II/III PROTECT/INSYNC SENTRY/MAXIMO ICDS/CONCERTO/II/MAXIMO II CRT-D (P010031/S187) | Medtronic Cardiac Rhythm Disease Management | 2010-03-18 |
| KAPPA 400 DR/SR IPG (P970012/S064) | Medtronic, Inc. | 2010-03-18 |
| CORONARY FLEXTONE CUTTING BALLOON (P950020/S035) | Boston Scientific Corp | 2010-03-18 |
| COMPLETE SE VASCULAR STENT SYSTEM (P090006) | Medtronic Vascular | 2010-03-17 |
| ESTEEM TOTALLY IMPLANTABLE HEARING SYSTEM (P090018) | Envoy Medical Corporation | 2010-03-17 |
| SMART NITINOL STENT SYSTEM/SMART CONTROL NITINOL STENT SYSTEMS (P020036/S017) | Cordis US Corporation | 2010-03-17 |
| MYNX VASCULAR CLOSURE DEVICE (P040044/S026) | Cordis US Corporation | 2010-03-17 |
| PRECISE/PRECISE RX/PRECISE PRO RX NITINOL STENT SYSTEMS (P030047/S020) | Cordis US Corporation | 2010-03-17 |
| OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (OXFORD PARTIAL KNEE SYSTEM) (P010014/S024) | Biomet Manufacturing Corp | 2010-03-17 |
| CAPSURE FIX LEAD (P980016/S221) | Medtronic Cardiac Rhythm Disease Management | 2010-03-16 |
| EPIC HF/ATLAS + HF FAMILY OF CRT-DS (P030054/S135) | ABBOTT MEDICAL | 2010-03-16 |
| CAPSURE Z LEADS (P850089/S063) | Medtronic Cardiac Rhythm Disease Management | 2010-03-16 |
| SELECTSECURE LEAD (P030036/S014) | Medtronic Cardiac Rhythm Disease Management | 2010-03-16 |
| AFFINITY / INTEGRITY /VICTORY FAMILY OF PACEMAKERS (P880086/S178) | ABBOTT MEDICAL | 2010-03-16 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S031) | ABBOTT MEDICAL | 2010-03-16 |
| LEAD END PIN, ACTIVE CAN EMULATOR HEADER, SIZING & UPSIZING SLEEVE (P900061/S085) | Medtronic Cardiac Rhythm Disease Management | 2010-03-16 |
| FRONTIER / FRONTIER II FAMILY OF CRT-PS (P030035/S059) | ABBOTT MEDICAL | 2010-03-16 |
| LEAD ADAPTOR, IS-1 PORT PIN PLUG, SPRINT, SPRINT FIDELIS, QUATTRO, QUATTRO SECURE & SUBCUTANEOUS DEFIBRILLATION LEADS (P920015/S057) | Medtronic, Inc. | 2010-03-16 |
| WRENCH KIT (P890003/S183) | Medtronic, Inc. | 2010-03-16 |
| SENSOLOG / DIALOG / REGENCY FAMILY OF PACEMAKERS (P880006/S064) | St. Jude Medical, Inc. | 2010-03-16 |
| CAPSURE, CAPSURE SP LEADS, AND CAPSURE SENSE LEADS (P830061/S048) | Medtronic Cardiac Rhythm Disease Management | 2010-03-16 |
| CAPSURE EPI UNIPOLAR AND CAPSURE EPI BIPOLAR LEADS (P950024/S018) | Medtronic, Inc. | 2010-03-16 |
| ADVIA CENTAUR HBC IGM ASSAY (P030040/S007) | Siemens Healthcare Diagnostics | 2010-03-16 |
| CADENCE FAMILY OF ICDS (P910023/S219) | ABBOTT MEDICAL | 2010-03-16 |
| CS-SVC TRANSVENE LEAD (P980050/S045) | Medtronic, Inc. | 2010-03-16 |
| PLASMAFLO OP-05W (A) (P820033/S005) | Asahi Kasei Medical Co., Ltd. | 2010-03-16 |
| HANCOCK II PORCINE BIOPROSTHESIS (P980043/S023) | Medtronic, Inc. | 2010-03-15 |
| BD FOCALPOINT GS IMAGING SYSTEM (P950009/S010) | Bd Diagnostics | 2010-03-15 |
| MOSAIC PORCINE BIOPROSTHESIS (P990064/S030) | Medtronic, Inc. | 2010-03-15 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S027) | Medtronic, Inc. | 2010-03-15 |
| HANCOCK I LOW POROSITY AND MODIFIED ORIFICE VALVED CONDUIT (P790007/S024) | Medtronic Heart Valves | 2010-03-15 |
| CONSULTA/MAXIMO II/CONCERTO II CRT-DS (P010031/S186) | Medtronic Cardiac Rhythm Disease Management | 2010-03-12 |
| CELSIUS THERMOCOOL & NAVISTAR THERMOCOOL (P030031/S027) | Biosense Webster, Inc. | 2010-03-12 |
| BIO-RAD MONOLISA ANTI-HBS EIA (P050048/S002) | Bio-Rad Laboratories | 2010-03-12 |
| SYMPHONY SR 2250/SYMPHONY DR 2550/RHAPSODY SR 2210/RHAPSODY DR 2510 & 2530 (P950029/S051) | MicroPort CRM USA, Inc. | 2010-03-12 |