| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S008) | W. L. Gore & Associates, Inc. | 2007-12-06 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S032) | W. L. Gore & Associates, Inc. | 2007-12-06 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S020) | W. L. Gore & Associates, Inc. | 2007-12-06 |
| PRIZM/VITALITY (P960040/S154) | Boston Scientific | 2007-12-05 |
| CONTRAK RENEWAL TR (P030005/S048) | Guidant Corp. | 2007-12-05 |
| ABBOTT ARCHITECT (P050051/S002) | Abbott Laboratories, Inc. | 2007-12-05 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S001) | ABBOTT MEDICAL | 2007-12-05 |
| VIGOR DR/SR/DISCOVER/MERIDIAN/PDP (P940031/S062) | Boston Scientific | 2007-12-05 |
| VENTAK MINI & CONTAK RENEWAL 3 (P910077/S081) | Boston Scientific | 2007-12-05 |
| CONTAK RENEWAL/VITALITY (P010012/S163) | Boston Scientific Corp | 2007-12-05 |
| INSYNC II MARQUIS (P010031/S085) | Medtronic Cardiac Rhythm Disease Management | 2007-12-04 |
| ENRHYTHM P1501 DR (P980035/S081) | Medtronic, Inc. | 2007-12-04 |
| AMPLATZER DUCT OCCLUDER (P020024/S017) | ABBOTT MEDICAL | 2007-12-04 |
| SILICONE ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (P880091/S023) | Staar Surgical Co. | 2007-12-04 |
| AMPLATZER SEPTAL OCCLUDER AND AMPLATZER MULTIFENESTRATED SEPTAL OCCLUDER-CRIBRIFORM (P000039/S023) | ABBOTT MEDICAL | 2007-12-04 |
| MEDTRONIC ICD'S (P980016/S115) | Medtronic Cardiac Rhythm Disease Management | 2007-12-04 |
| PRECISE NITINOL STENT SYSTEM & PRECISE RX NITINOL STENT SYSTEM & PRECISE PRO RX NITINOL STENT SYSTEM (P030047/S008) | Cordis US Corporation | 2007-11-30 |
| CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060/S039) | Corcym S.r.l. | 2007-11-30 |
| ACRYSOF INTRAOCULAR LENSES (IOL) (P930014/S022) | Alcon Laboratories, Inc. | 2007-11-30 |
| MULTI-LINK RX ULTRA CORONARY STENT SYSTEM (P970020/S051) | Abbott Vascular, Inc. | 2007-11-30 |
| TRUFIL N-BCA LIQUID EMBOLIC SYSTEM (P990040/S006) | Cerenovus, Inc. | 2007-11-30 |
| SMART NITINOL SYSTEM & SMART CONTROL NITINOL STENT SYSTEM (P020036/S009) | Cordis US Corporation | 2007-11-30 |
| C2-A TAPER ACETABULAR SYSTEM (P050009/S005) | Biomet, Inc. | 2007-11-30 |
| JUVEDERM HYALURONANTE GEL IMPLANTS (P050047/S002) | Allergan | 2007-11-30 |
| PTCA DILATATION CATHETERS (P880003/S093) | Cordis Corp. | 2007-11-30 |
| ACRYSOF INTRAOCULAR LENSES (IOL) (P040020/S006) | Alcon Research, Ltd. | 2007-11-30 |
| FLOSEAL HEMOSTATIC MATRIX (P990009/S020) | Baxter Healthcare Corp | 2007-11-30 |
| COSEAL SURGICAL SEALANT (P030039/S007) | Baxter Bio Science | 2007-11-30 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S051) | Terumo Medical Corporation | 2007-11-29 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S019) | Medtronic, Inc. | 2007-11-29 |
| MOSAIC PORCINE BIOPROSTHESIS (P990064/S019) | Medtronic, Inc. | 2007-11-29 |
| NAVISTAR THERMOCOOL CATHETER FOR TREATMENT OF TYPE I ATRIAL FLUTTER (P030031/S006) | Biosense Webster, Inc. | 2007-11-28 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S045) | Cochlear Americas | 2007-11-28 |
| EMODOGAIN (P930021/S010) | The Straumann Company | 2007-11-28 |
| INSTAT COLLAGEN ABSORBABLE HEMOSTAT (P830079/S017) | ETHICON, Inc. | 2007-11-28 |
| DRIVER & MICRO-DRIVER CORONARY STENT SYSTEMS (P030009/S016) | Medtronic, Ireland | 2007-11-28 |
| CELSIUS RMT CATHETER (P950005/S022) | Biosense Webster, Inc. | 2007-11-28 |
| QUANTIFERON TB GOLD (P010033/S012) | Qiagen | 2007-11-28 |
| IN VITRO DIAGNOSTIC PRODUCT ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S010) | Beckman Coulter, Inc. | 2007-11-27 |
| CODMAN 3000 IMPLANTABLE INFUSION PUMP (P890055/S023) | Intera Oncology | 2007-11-26 |
| COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P810006/S030) | Integra LifeSciences Corporation | 2007-11-23 |
| INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S018) | Integra Lifesciences Corp. | 2007-11-23 |
| COLLACOTE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P840062/S016) | Integra Lifesciences Corp. | 2007-11-23 |
| HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S027) | Integra LifeSciences Corporation | 2007-11-23 |
| MOSAIC PROCINE BIOPROSTHESIS (P990064/S021) | Medtronic, Inc. | 2007-11-21 |
| HANCOCK MODIFIED ORIFICE (MO) VALVED CONDUIT (P790007/S021) | Medtronic Heart Valves | 2007-11-21 |
| PERCUTANEOUS VASCULAR CLOSURE SURGICAL (PVS) & SUTURE MEDICATED CLOSURE (SMC) SYSTEM (P960043/S062) | Abbott Vascular, Inc. | 2007-11-21 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S022) | Medtronic, Inc. | 2007-11-21 |
| ST JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S060) | ABBOTT MEDICAL | 2007-11-21 |
| PRECISION SPINAL CORD STIMULATOR SYSTEM (P030017/S028) | Boston Scientific Corp | 2007-11-21 |
| CONTAK CD/EASYTRAK DEVICES (P010012/S161) | Boston Scientific Corp | 2007-11-21 |
| VENTAK AV/VR (VENTAK PRIZM) DEVICES (P960040/S152) | Boston Scientific | 2007-11-21 |
| PERCUTANEOUS VASCULAR CLOSURE SURGICAL (PVS) & SUTURE MEDICATED CLOSURE (SMC) SYSTEMS (P960043/S061) | Abbott Vascular, Inc. | 2007-11-21 |
| EASYTRACK 2 FAMILY OF LEADS (P010012/S158) | Boston Scientific Corp | 2007-11-21 |
| INFUSION PUMP (P860004/S092) | Medtronic, Inc. | 2007-11-21 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S038) | Cordis Corp. | 2007-11-21 |
| HANCOCK II PORCINE BIOPROSTHESIS (P980043/S014) | Medtronic, Inc. | 2007-11-21 |
| X-STOP INTERSPINOUS DECOMPRESSION SYSTEM (P040001/S005) | Medtronic Sofamor Danek, Inc. | 2007-11-20 |
| PROLIEVE THERMODILATATION SYSTEM (P030006/S013) | Medifocus, Inc. | 2007-11-20 |
| UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES (P880081/S035) | Johnson & Johnson Surgical Vision, Inc. | 2007-11-19 |
| CEEON & TECNIS UV-ABORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (P990080/S028) | Johnson & Johnson Surgical Vision, Inc. | 2007-11-19 |
| COSMETIC TISSUE AUGMENTATION PRODUCT (CTA) (P050033/S003) | Anika Therapeutics, Inc. | 2007-11-19 |
| SENSAR SOFT ACRYLIC POSTERIOR CHAMBER INTRACULAR LENSES (P980040/S019) | Johnson & Johnson Surgical Vision, Inc. | 2007-11-19 |
| MULTIFOCAL SILICONE & MULTIFOCAL ACRYLIC POSTERIOR CHAMBER INTRAOCULAR LENSES (P960028/S025) | Johnson & Johnson Surgical Vision, Inc. | 2007-11-19 |
| VARIOUS FAMILIES OF PACEMAKERS (P990001/S034) | Medtronic, Inc. | 2007-11-16 |
| GEM III AT ICD (P980050/S031) | Medtronic, Inc. | 2007-11-16 |
| KAPPA 400 DR IPG AND KAPPA 400 SR IPG (P970012/S031) | Medtronic, Inc. | 2007-11-16 |
| INSYNC CRT-D; CONCERTO & VARIOUS INSYNC FAMILY OF ICDS (P010031/S082) | Medtronic Cardiac Rhythm Disease Management | 2007-11-16 |
| CONCERTO (P010031/S083) | Medtronic Cardiac Rhythm Disease Management | 2007-11-16 |
| VIRTUOSO (P980016/S113) | Medtronic Cardiac Rhythm Disease Management | 2007-11-16 |
| PRODIGY/THERA-I PACEMAKERS (P890003/S130) | Medtronic, Inc. | 2007-11-16 |
| VARIOUS FAMILIES OF ICDS (P980016/S112) | Medtronic Cardiac Rhythm Disease Management | 2007-11-16 |
| VARIOUS FAMILIES OF PACEMAKERS (P980035/S080) | Medtronic, Inc. | 2007-11-16 |
| INSYNC CRT-P, INSYNC II CRT-P (P010015/S035) | Medtronic, Inc. | 2007-11-16 |
| SJM EPIC VALVE AND SJM EPIC SUPRA VALVE (P040021/S004) | ABBOTT MEDICAL | 2007-11-15 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S031) | W. L. Gore & Associates, Inc. | 2007-11-15 |
| NAVISTAR CATHETERS (P040036/S005) | Biosense Webster, Inc. | 2007-11-14 |
| LATITUDE INDUCTIVE PATIENT MANAGEMENT COMMUNICATOR (P910077/S080) | Boston Scientific | 2007-11-14 |
| CONTAK RENEWAL FAMILY (P010012/S159) | Boston Scientific Corp | 2007-11-14 |
| THORATEC TLC-II PORTABLE VAD DRIVER (P870072/S037) | Thoratec Laboratories Corp. | 2007-11-14 |
| DURALOC OPTION CERAMIC HIP SYSTEM (P040023/S010) | DePuy Orthopaedics, Inc. | 2007-11-14 |
| PRIZM, PRIZM AT & VITALITY FAMILIES (P960040/S151) | Boston Scientific | 2007-11-14 |
| NAVISTAR & CELSIUS CATHETERS (P030031/S008) | Biosense Webster, Inc. | 2007-11-14 |
| MYNX VASCULAR CLOSURE DEVICE (P040044/S003) | Cordis US Corporation | 2007-11-14 |
| VNS THERAPY SYSTEM (P970003/S092) | LivaNova USA, Inc. | 2007-11-14 |
| ALL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P980049/S028) | MicroPort CRM USA, Inc. | 2007-11-13 |
| SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEMS (P050012/S011) | Dexcom, Inc. | 2007-11-13 |
| AMS 800 ARTIFICAL URINARY SPHINCTER (P000053/S012) | Boston Scientific Corp | 2007-11-13 |
| ALL RATE RESPONSIVE IMPLANTABLE PACEMAKERS (P950029/S031) | MicroPort CRM USA, Inc. | 2007-11-13 |
| ALL NON-RATE RESPONSIVE PACEMAKERS (P900022/S009) | MicroPort CRM USA, Inc. | 2007-11-13 |
| PRODIGY/THERA-I PACEMAKERS (P890003/S128) | Medtronic, Inc. | 2007-11-09 |
| ZILVER VASCULAR STENT (P050017/S001) | Cook Ireland, Ltd. | 2007-11-09 |
| CARDIOMESSENGER II (P950037/S054) | Biotronik, Inc. | 2007-11-09 |
| MEDTRONIC CARELINK MONITOR (P890003/S127) | Medtronic, Inc. | 2007-11-09 |
| VARIOUS FAMILIES OF PACEMAKERS (P990001/S032) | Medtronic, Inc. | 2007-11-09 |
| KAPPA 400 DR IPG & KAPPA 400 SR IPG PACEMAKERS (P970012/S029) | Medtronic, Inc. | 2007-11-09 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S026) | W. L. Gore & Associates, Inc. | 2007-11-09 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S030) | W. L. Gore & Associates, Inc. | 2007-11-09 |
| EASYTRAK 2 FAMILY OF LEADS (P010012/S152) | Boston Scientific Corp | 2007-11-09 |
| INSYNC CRT-P & INSYNC III CRT-P (P010015/S033) | Medtronic, Inc. | 2007-11-09 |