| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S032) | W. L. Gore & Associates, Inc. | 2009-11-20 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S025) | W. L. Gore & Associates, Inc. | 2009-11-20 |
| TALENT THORACIC STENT GRAFT SYSTEM (P070007/S010) | Medtronic Vascular | 2009-11-20 |
| TENDRIL LEADS (P960013/S053) | ABBOTT MEDICAL | 2009-11-20 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S048) | W. L. Gore & Associates, Inc. | 2009-11-20 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S015) | W. L. Gore & Associates, Inc. | 2009-11-20 |
| SJM ACTIVE & PASSIVE LEADS (P960030/S015) | ABBOTT MEDICAL | 2009-11-19 |
| SJM ACTIVE & PASSIVE LEADS (P960013/S028) | ABBOTT MEDICAL | 2009-11-19 |
| PERCLOSE PROGLIDE SUTURE-MEDIATED CLOSURE SYSTEM & PERCLOSE A T 6F SUTURE-MEDIATED CLOSURE SYSTEM (P960043/S069) | Abbott Vascular, Inc. | 2009-11-18 |
| EPIC HF/ATLAS + HF CRT-DS (P030054/S138) | ABBOTT MEDICAL | 2009-11-18 |
| ACRYSOF INTRAOCULAR LENSES (P930014/S036) | Alcon Laboratories, Inc. | 2009-11-18 |
| TALENT ABDOMINAL STENT GRAFT SYSTEM (P070027/S009) | Medtronic Vascular | 2009-11-18 |
| CADENCE ICDS (P910023/S222) | ABBOTT MEDICAL | 2009-11-18 |
| ACRYSOF INTRAOCULAR LENSES (P040020/S021) | Alcon Research, Ltd. | 2009-11-18 |
| MODEL 6476 G2 RF LATITUDE COMMUNICATOR (P910077/S098) | Boston Scientific | 2009-11-16 |
| MACROPLASTIQUE IMPLANTS (P040050/S004) | Uroplasty, LLC | 2009-11-16 |
| CONTAK RENEWAL/VITALITY (P010012/S213) | Boston Scientific Corp | 2009-11-16 |
| VIGOR DR/SR/DISCOVER/MERIDIAN/PDP (P940031/S065) | Boston Scientific | 2009-11-16 |
| CONTAK RENEWAL TR (P030005/S058) | Guidant Corp. | 2009-11-16 |
| NEOVENTA'S STAN S31 FETAL HEART MONITOR (P020001/S006) | Neoventa Medical AB | 2009-11-16 |
| XACT CAROTID STENT SYSTEM (P040038/S020) | Abbott Vascular, Inc. | 2009-11-16 |
| PRIZM/VITALITY (P960040/S199) | Boston Scientific | 2009-11-16 |
| BD PREPSTAIN SYSTEM (P970018/S017) | Bd Diagnostic Systems | 2009-11-16 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S027) | Abbott Vascular, Inc. | 2009-11-16 |
| CADENCE ICD SYSTEM (P910023/S216) | ABBOTT MEDICAL | 2009-11-13 |
| EPIC HF CRT-D SYSTEM (P030054/S133) | ABBOTT MEDICAL | 2009-11-13 |
| GEM 21S GROWTH FACTOR ENHANCED MATRIX (P040013/S015) | Lynch Biologics, LLC | 2009-11-13 |
| UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (P970034/S013) | Aaren Scientific | 2009-11-13 |
| STARCLOSE SE VASCULAR CLOSURE SYSTEM (P050007/S015) | Abbott Vascular Devices | 2009-11-13 |
| ENDEAVOR ZOTAROLIMUS & SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S033) | Medtronic, Inc. | 2009-11-13 |
| NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM (P000015/S011) | Cochlear Americas | 2009-11-12 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S055) | Cochlear Americas | 2009-11-12 |
| DRIVER CORONARY STENT SYSTEMS (P030009/S036) | Medtronic, Ireland | 2009-11-12 |
| GRUNTZIG DILACA BALLOON DILATATION CATHETERS (P790017/S101) | Medtronic, Ireland | 2009-11-12 |
| NUCLEUS 22 COCHLEAR IMPLANT SYSTEM (P890027/S057) | Cochlear Americas | 2009-11-12 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S029) | W. L. Gore & Associates, Inc. | 2009-11-12 |
| ENDEAVOR & ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S044) | Medtronic, Inc. | 2009-11-12 |
| NUCLEUS 22 COCHLEAR IMPLANT SYSTEM (P840024/S088) | Cochlear Americas | 2009-11-12 |
| VISTAKON (SENOFILCON A) CONTACT LENS (P040045/S009) | Vistakon, Division of Johnson & Johnson Vision Car | 2009-11-10 |
| CARDIAC RESYNCHRONIZATION HE DEFIBRILLATOR (P010012/S217) | Boston Scientific Corp | 2009-11-10 |
| TALENT THORACIC STENT GRAFT SYSTEM (P070007/S013) | Medtronic Vascular | 2009-11-10 |
| NATRELLE SALINE-FILLED BREAST IMPLANTS (P990074/S022) | Allergan | 2009-11-10 |
| NATRELLE SILICONE-FILLED BREAST IMPLANTS (P020056/S011) | Allergan | 2009-11-10 |
| COGNIS/TELIGEN (P960040/S202) | Boston Scientific | 2009-11-10 |
| LCS TOTAL KNEE SYSTEM (P830055/S108) | Depuy, Inc. | 2009-11-09 |
| RESTYLANE INJECTABLE GEL (P040024/S044) | Q-Med AB | 2009-11-06 |
| XACT CAROTID STENT SYSTEM (P040038/S019) | Abbott Vascular, Inc. | 2009-11-06 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES (P860057/S060) | Edwards Lifesciences, LLC | 2009-11-06 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S096) | Boston Scientific Corp | 2009-11-05 |
| CAPSURE FIX LEADS (P930039/S034) | Medtronic, Inc. | 2009-11-05 |
| INSYNC & INSYNC III CRT-P (P010015/S047) | Medtronic, Inc. | 2009-11-05 |
| VARIOUS FAMILY OF PACEMAKERS (P980035/S106) | Medtronic, Inc. | 2009-11-05 |
| KAPPA 400 DR IPG & SR IPG PACEMAKERS (P970012/S037) | Medtronic, Inc. | 2009-11-05 |
| INSYNC CRT-P & INSYNC III CRT-P (P010015/S046) | Medtronic, Inc. | 2009-11-05 |
| INSYNC CRT-D & CONCERTO/CONSULTA CRT-D/MAXIMO II CRT-D & VARIOUS INSYNC FAMILES ODF ICDS (P010031/S113) | Medtronic Cardiac Rhythm Disease Management | 2009-11-05 |
| CAPSURE LEADS (P890003/S176) | Medtronic, Inc. | 2009-11-05 |
| VARIOUS FAMILIES OF PACEMAKERS (P980035/S103) | Medtronic, Inc. | 2009-11-05 |
| VARIOUS FAMILIES OF ICDS (P980016/S138) | Medtronic Cardiac Rhythm Disease Management | 2009-11-05 |
| PRODIGY/THERA I IPG (P890003/S144) | Medtronic, Inc. | 2009-11-05 |
| RADIESSE INJECTABLE IMPLANT (P050037/S021) | Merz North America, Inc. | 2009-11-05 |
| FIRE STAR RX PTCA BALLOON DILATATION CATHETER (P880003/S097) | Cordis Corp. | 2009-11-05 |
| VARIOUS FAMILIES OF ICDS (P980016/S144) | Medtronic Cardiac Rhythm Disease Management | 2009-11-05 |
| PARADIGM REAL-TIME PUMP (P980022/S064) | Medtronic Minimed | 2009-11-05 |
| INSYNC CRT-D, CONCERTO & VARIOUS INSYNC FAMILIES OF ICDS (P010031/S107) | Medtronic Cardiac Rhythm Disease Management | 2009-11-05 |
| PRODIGY/THERA I IPG (P890003/S143) | Medtronic, Inc. | 2009-11-05 |
| RADIESSE INJECTABLE IMPLANT (P050052/S024) | Merz North America, Inc. | 2009-11-05 |
| KAPPA 400 DR/SR IPG (P970012/S036) | Medtronic, Inc. | 2009-11-05 |
| SPECTRANETICS LASER SHEATH (SLS) (P960042/S012) | Spectranetics (Philips) | 2009-11-05 |
| CAPSURE FIX LEADS (P980016/S210) | Medtronic Cardiac Rhythm Disease Management | 2009-11-05 |
| TLC-II PLUS PORTABLE VAD DRIVER (P870072/S042) | Thoratec Laboratories Corp. | 2009-11-05 |
| SOF-SENSOR GLUCOSE SENSORS (P980022/S061) | Medtronic Minimed | 2009-11-05 |
| TECHNOLAS 217A EXCIMER LASER SYSTEM (P990027/S013) | Technolas Perfect Vision GmbH | 2009-11-04 |
| HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM (P000032/S029) | CooperSurgical, Inc. | 2009-11-04 |
| HANCOCK II PORCINE BIOPROSTHESIS (P980043/S022) | Medtronic, Inc. | 2009-11-03 |
| APLIGRAF (P950032/S052) | Organogenesis, Inc. | 2009-11-03 |
| CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS (P860057/S057) | Edwards Lifesciences, LLC | 2009-11-03 |
| HANCOCK I LOW POROSITY AND MODIFIED ORIFICE VALVED CONDUIT, MODELS 105 AND 150 (P790007/S023) | Medtronic Heart Valves | 2009-11-03 |
| MOSAIC PORCINE BIOPRSTHESIS (P990064/S029) | Medtronic, Inc. | 2009-11-03 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S026) | Medtronic, Inc. | 2009-11-03 |
| PROSTAR XL 10F PERCUTANEOUS VASCULAR SURGICAL SYSTEM (P960043/S068) | Abbott Vascular, Inc. | 2009-11-03 |
| CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM (P030042) | Microport Orthopedics, Inc. | 2009-11-03 |
| DEFLUX INJECTABLE GEL (P000029/S059) | Palette Life Sciences | 2009-10-30 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S069) | Cordis Corp. | 2009-10-30 |
| SYNCHROMED & ISOMED DRUG INFUSION SYSTEMS (P990034/S014) | Medtronic, Inc. | 2009-10-30 |
| SYNCHROMED & ISOMED DRUG INFUSION SYSTEMS (P860004/S114) | Medtronic, Inc. | 2009-10-30 |
| SPRINT FIDELIS & QUATTRO (P920015/S040) | Medtronic, Inc. | 2009-10-30 |
| IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS (P910077/S096) | Boston Scientific | 2009-10-30 |
| CAPSURE SENSE & SP NOVUS (P830061/S040) | Medtronic Cardiac Rhythm Disease Management | 2009-10-30 |
| ANGIOSCULPT PTCA SCORING BALLOON CATHETER (P050018/S006) | Spectranetics Corp. | 2009-10-30 |
| CAPSURE SP NOVUS & CAPSURE Z NOVUS (P850089/S057) | Medtronic Cardiac Rhythm Disease Management | 2009-10-30 |
| CAPSURE FIX NOVUS & SUREFIX & CAPSURE FIX (P930039/S025) | Medtronic, Inc. | 2009-10-30 |
| CONSULTA/CONCERTO II/MAXIMO II CRT-DS (P010031/S168) | Medtronic Cardiac Rhythm Disease Management | 2009-10-30 |
| DEFLUX INJECTABLE GEL (P000029/S058) | Palette Life Sciences | 2009-10-30 |
| DEFLUX INJECTABLE GEL (P000029/S057) | Palette Life Sciences | 2009-10-30 |
| SILIKON 1000 (P950008/S007) | Alcon | 2009-10-30 |
| SECURA/VIRTUOSO II/MAXIMO II ICDS (P980016/S207) | Medtronic Cardiac Rhythm Disease Management | 2009-10-30 |
| CAPSURE EPI (P950024/S009) | Medtronic, Inc. | 2009-10-30 |
| ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S042) | Medtronic, Inc. | 2009-10-30 |
| PALMAZ BALLOON-EXPANDABLE STENT (P890017/S015) | Cordis US Corporation | 2009-10-30 |
| RESTOR POSTERIOR CHAMBER INTRAOCULAR LENSES (P040020/S018) | Alcon Research, Ltd. | 2009-10-29 |