| MULTI-LINK VISION FAMILY OF CORONARY STENT SYSTEMS (P020047/S015) | Abbott Vascular | 2009-07-28 |
| DUAL CHAMBER, IMPLANTABLE PULSE GENERATOR (P820003/S092) | Medtronic Cardiac Rhythm Disease Management | 2009-07-28 |
| SCULPTRA AESTHETIC (P030050/S002) | Q-Med AB | 2009-07-28 |
| MODEL 2090 MEDTRONIC CARELINK PROGRAMMER (P980016/S197) | Medtronic Cardiac Rhythm Disease Management | 2009-07-28 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S025) | Medtronic, Inc. | 2009-07-27 |
| STARCLOSE SE VASCULAR CLOSURE SYSTEM (P050007/S016) | Abbott Vascular Devices | 2009-07-27 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S012) | W. L. Gore & Associates, Inc. | 2009-07-27 |
| HANCOCK I LOW POROSITY & MODIFIED ORIFICE VALVED CONDUIT (P790007/S022) | Medtronic Heart Valves | 2009-07-27 |
| MOSAIC PORCINE BIOPROSTHESIS (P990064/S027) | Medtronic, Inc. | 2009-07-27 |
| HANCOCK II PORCINE BIOPROSTHESIS (P980043/S020) | Medtronic, Inc. | 2009-07-27 |
| ZENITH AAA ENDOVASCULAR GRAFT (P020018/S033) | Cook, Inc. | 2009-07-24 |
| BD FOCALPOINT SYSTEM (P950009/S009) | Bd Diagnostics | 2009-07-24 |
| 7F FISH-SP DEVICE (P050043/S002) | Morris Innovative Research, Inc. | 2009-07-24 |
| PREPSTAIN SYSTEM (P970018/S015) | Bd Diagnostic Systems | 2009-07-24 |
| CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT (P870056/S034) | Edwards Lifesciences, LLC | 2009-07-23 |
| ACRYSOF MONFOCAL/ACRYSOF TORIC POSTERIOR CHAMBER INTRAOCULAR LENSES/ACRYSERT DELIVERY SYSTEM (P930014/S035) | Alcon Laboratories, Inc. | 2009-07-23 |
| CADENCE FAMILY OF ICDS (P910023/S214) | ABBOTT MEDICAL | 2009-07-23 |
| INTRAOCULAR LENS (P080004/S002) | Hoya Surgical Optics, Inc. | 2009-07-23 |
| XACT CAROTID STENT SYSTEM (P040038/S015) | Abbott Vascular, Inc. | 2009-07-23 |
| ZILVER VASCULAR STENT (P050017/S004) | Cook Ireland, Ltd. | 2009-07-23 |
| EPIC HF/ATLAS+ FAMILY OF CRT-DS (P030054/S129) | ABBOTT MEDICAL | 2009-07-23 |
| VITAGEL SURGICAL HEMOSTAT (P050044/S009) | Stryker Corp. | 2009-07-23 |
| TECNIS 1 PIECE IOL MODEL ZCB00 (P980040/S028) | Johnson & Johnson Surgical Vision, Inc. | 2009-07-23 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S061) | Cordis Corp. | 2009-07-23 |
| ACRYSOF MULTIFOCAL POSTERRIOR CHAMBER INTRAOCULAR LENSES (P040020/S019) | Alcon Research, Ltd. | 2009-07-23 |
| ARCHITECT AUSAB, ARCHITECT I1000 SYSTEM (P050051/S004) | Abbott Laboratories, Inc. | 2009-07-23 |
| PMMA SINGLE-PIECE ANTERIOR CHAMBER INTRAOCULAR LENSES (P880087/S013) | Alcon Laboratories | 2009-07-23 |
| TECNIS MULTIFOCAL IOLS (P080010/S004) | Johnson & Johnson Surgical Vision, Inc. | 2009-07-23 |
| VNS THERAPY SYSTEM (P970003/S104) | LivaNova USA, Inc. | 2009-07-23 |
| PMMA SINGLE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES (P840060/S031) | Alcon Laboratories | 2009-07-23 |
| PMMA MULTI-PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES (P810032/S054) | Alcon Laboratories | 2009-07-23 |
| CERVISTA HPV HR (P080014/S001) | Hologic, Inc. | 2009-07-22 |
| PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S030) | Boston Scientific Corp | 2009-07-22 |
| ARTEGRAFT COLLAGEN VASCULAR GRAFT (N16837/S007) | LeMaitre Vascular, Inc. | 2009-07-21 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S058) | Edwards Lifesciences, LLC | 2009-07-21 |
| LATITUDE PATIENT MANAGEMENT SYSTEM (P910077/S094) | Boston Scientific | 2009-07-21 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S030) | ABBOTT MEDICAL | 2009-07-17 |
| EPIC HF/ATLAS+HF FAMILY OF CRT-DS (P030054/S128) | ABBOTT MEDICAL | 2009-07-17 |
| CADENCE FAMILY OF ICDS (P910023/S213) | ABBOTT MEDICAL | 2009-07-17 |
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S063) | St. Jude Medical, Inc. | 2009-07-17 |
| TECNIS 1 PIECE IOL MODEL ZCB00 (P980040/S027) | Johnson & Johnson Surgical Vision, Inc. | 2009-07-17 |
| BARD LIFESTENT VASCULAR STENT SYSTEMS (P070014/S002) | Bard Peripheral Vascular, Inc. | 2009-07-17 |
| TECNIS MULTIFOCAL SILICONE IOL/MODEL ZM900 & THE TECNIS MULTIFOCAL FOLDABLE ACRYLIC IOL MODEL ZMA00 (P080010/S003) | Johnson & Johnson Surgical Vision, Inc. | 2009-07-17 |
| XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS) (P070015/S021) | Abbott Vascular, Inc. | 2009-07-17 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S044) | W. L. Gore & Associates, Inc. | 2009-07-17 |
| AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S177) | ABBOTT MEDICAL | 2009-07-17 |
| FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S057) | ABBOTT MEDICAL | 2009-07-17 |
| SOFLEX & SOFPORT POSTERIOR CHAMBER INTRAOCULAR LENSES (P910061/S018) | Bausch & Lomb | 2009-07-16 |
| ACRYSOF UV ABSORBING INTRAOCULAR LENSES (P930014/S025) | Alcon Laboratories, Inc. | 2009-07-16 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S051) | Cochlear Americas | 2009-07-16 |
| ESSURE SYSTEM (P020014/S026) | Bayer Pharma AG | 2009-07-16 |
| SOF-SENSOR GLUCOSE SENSOR (P980022/S056) | Medtronic Minimed | 2009-07-16 |
| AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S174) | ABBOTT MEDICAL | 2009-07-15 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021/S016) | Ortho-Clinical Diagnostics, Inc. | 2009-07-15 |
| VOYAGER NC CORONARY DILATATION CATHETER (P810046/S230) | Advanced Cardiovascular Systems, Inc. | 2009-07-15 |
| FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S053) | ABBOTT MEDICAL | 2009-07-15 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR (P030026/S016) | Ortho-Clinical Diagnostics, Inc. | 2009-07-15 |
| REPLY DR/SR (P950029/S046) | MicroPort CRM USA, Inc. | 2009-07-15 |
| ISOLINE 2CR PACINGS LEADS (P980049/S049) | MicroPort CRM USA, Inc. | 2009-07-15 |
| MYNX VASCULAR CLOSURE DEVICE (P040044/S015) | Cordis US Corporation | 2009-07-13 |
| ABBOTT ARCHITECT HBSAG/ARCHITECT HBSAG CONFIRMATORY/ARCHITECT I1000SR SYSTEM (P060007/S002) | Abbott Laboratories | 2009-07-13 |
| RADIESSE INJECTABLE IMPLANT (P050052/S019) | Merz North America, Inc. | 2009-07-13 |
| ENDEAVOR & ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING STENT SYSTEM (P060033/S031) | Medtronic, Inc. | 2009-07-13 |
| TAXUS LIBERTE' PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S011) | Boston Scientific Corp | 2009-07-13 |
| SPINAL CORD STIMULATION FAMILY OF NEUROSTIMULATION LEADS (P840001/S139) | Medtronic Neuromodulation | 2009-07-10 |
| REGENCY PACEMAKERS (P880006/S062) | St. Jude Medical, Inc. | 2009-07-10 |
| INTERSTIM FAMILY OF NEUROSTIMULATION LEADS (P970004/S074) | Medtronic Neuromodulation | 2009-07-10 |
| ADDVENT/AFFINITY/IDENTITY/VERITY/INTEGRITY/VICTORY/ZEPHYR PACEMAKERS (P880086/S176) | ABBOTT MEDICAL | 2009-07-10 |
| DURATA LEAD MODELS (P950022/S060) | ABBOTT MEDICAL | 2009-07-10 |
| MICRONY PACEMAKERS (P970013/S029) | ABBOTT MEDICAL | 2009-07-10 |
| RIATA/RIATA ST/DURATA LEADS (P950022/S062) | ABBOTT MEDICAL | 2009-07-10 |
| PHYSIO-STIM & SPINAL-STIM (P850007/S028) | Orthofix, Inc. | 2009-07-10 |
| GORE VIABAHN TIPS ENDOPROSTHESIS (P040027/S015) | W. L. Gore & Associates, Inc. | 2009-07-10 |
| INSYNC CRT-P/INSYNC III CRT-P (P010015/S069) | Medtronic, Inc. | 2009-07-10 |
| INSYNC FAMILY OF ICDS/CONCERTO/MAXIMO II CRT-D/CONSULTA CRT-D (P010031/S157) | Medtronic Cardiac Rhythm Disease Management | 2009-07-10 |
| CERVICAL STIM (P030034/S002) | Orthofix, Inc. | 2009-07-10 |
| GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM (P990066/S033) | GE Healthcare | 2009-07-10 |
| TENDRIL/TENDRIL ST/OPTISENSE LEADS (P960013/S047) | ABBOTT MEDICAL | 2009-07-10 |
| KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENSIA IPGS (P980035/S137) | Medtronic, Inc. | 2009-07-10 |
| DEMA IPG/DDDR/CLARITY SSIR/DIAMOND III/RUBY III/TOPAZ III/JADE III/VITA 2 DDDR (P990001/S054) | Medtronic, Inc. | 2009-07-10 |
| EPIC HF/EPIC+ HF/EPIC II HF/EPIC II+HF/ATLAS HF/ATLAS+HF/ATLAS II HF/ATLAS II+HF CRT-DS/QUICKSITE/QUICKFLEX LEADS (P030054/S127) | ABBOTT MEDICAL | 2009-07-10 |
| COGNIS FAMILIES (P010012/S216) | Boston Scientific Corp | 2009-07-10 |
| TELIGEN FAMILIES (P960040/S201) | Boston Scientific | 2009-07-10 |
| RESTYLANE INJECTABLE GEL (P040024/S041) | Q-Med AB | 2009-07-10 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S021) | W. L. Gore & Associates, Inc. | 2009-07-10 |
| PASSIVE PLUS/ISOFLEX S/ISOFLEX P/ISOFLEX OPTIM LEADS (P960030/S026) | ABBOTT MEDICAL | 2009-07-10 |
| KAPPA 400 DR IPG/KAPPA 400 SR IPG (P970012/S055) | Medtronic, Inc. | 2009-07-10 |
| GEM II/MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO ICDS/MAXIMO II CRT-D/SECURA FAMILY ICD (P980016/S196) | Medtronic Cardiac Rhythm Disease Management | 2009-07-10 |
| CADENCE ICDS (P910023/S212) | ABBOTT MEDICAL | 2009-07-10 |
| FRONTIER/FRONTIER II PACEMAKERS/AESCULA LEADS (P030035/S056) | ABBOTT MEDICAL | 2009-07-10 |
| XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS) (P070015/S017) | Abbott Vascular, Inc. | 2009-07-09 |
| CARPENTIER-EDWARDS BIOPROSTHETIC PULMONIC VALVED CONDUIT (P870056/S033) | Edwards Lifesciences, LLC | 2009-07-09 |
| SUTURE MEDIATED CLOSURE SYSTEMS & ASSOCIATED ACCESSORIES (P960043/S065) | Abbott Vascular, Inc. | 2009-07-09 |
| CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS (P860057/S056) | Edwards Lifesciences, LLC | 2009-07-09 |
| MEDTRONIC HALL ROTATABLE AORTIC VALVE COLLAGEN IMPREGNATED CONDUIT (P790018/S052) | Medtronic Cardiac Surgery | 2009-07-09 |
| GENESEARCH BREAST LYMPH NODE ASSAY (P060017/S003) | Janssen Diagnostics | 2009-07-09 |
| VASCULAR CLOSURE SYSTEMS (P050007/S014) | Abbott Vascular Devices | 2009-07-09 |
| ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S031) | Boston Scientific Corp | 2009-07-09 |
| ABBOTT AXSYM ANTIBODY TO HCV (ANTI-HCV) (P970027/S007) | Abbott Laboratories | 2009-07-08 |
| EP TECH CARDIAC ABLATION SYSTEM (P920047/S031) | Boston Scientific Corp | 2009-07-08 |