| ELECSYS ANTI-HBS IMMUNOASSAY (P010054/S010) | Roche Diagnostics Corp. | 2008-09-23 |
| DRIVER RAPID EXCHANGE (RX) CORONARY STENT SYSTEM (P030009/S021) | Medtronic, Ireland | 2008-09-22 |
| ALLERGAN SALINE-FILLED BREAST IMPLANTS (P990074/S019) | Allergan | 2008-09-19 |
| GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM (P970021/S023) | Gynecare, Inc. | 2008-09-19 |
| STARCLOSE VASCULAR CLOSURE SYSTEM (P050007/S012) | Abbott Vascular Devices | 2008-09-19 |
| HEALON, HEALON GV/HEALON 5 SODIUM HYALURONATE OPHTHALMIC VISCOSURGICAL DEVICES (P810031/S036) | Johnson & Johnson Surgical Vision, Inc. | 2008-09-19 |
| CHILLI COOLED ABLATION CATHETER (P980003/S021) | Boston Scientific Corp | 2008-09-19 |
| VITRAX/HEALON D SODIUM HYALURONATE SOLUTION OPHTHALMIC VISCOSURGICAL DEVICES (P880031/S015) | Abbott Medical Optics, Inc. | 2008-09-19 |
| ABIOMED ARTERIAL CANNULA (P900023/S050) | Abiomed Cardiovascular, Inc. | 2008-09-18 |
| UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (P970034/S012) | Aaren Scientific | 2008-09-18 |
| OXFORD MENISCAL UNICOMPARTMENTAL KNEE (OXFORD PARTIAL KNEE SYSTEM) (P010014/S020) | Biomet Manufacturing Corp | 2008-09-18 |
| DURATA, RIATA ST OPTIM, RIATA ST, RIATA 8F (P950022/S052) | ABBOTT MEDICAL | 2008-09-18 |
| SPF PLUS-MINI (60UA/W) AND SPF PLUS-MINI (60UA/M) (P850035/S033) | Ahp Eos Buyer, Inc. | 2008-09-18 |
| ANTERIOR CHAMBER INTRAOCULAR LENS (P010027/S002) | Aaren Scientific | 2008-09-18 |
| ELECSYS TOTAL PSA (P990056/S009) | Roche Diagnostics Corp. | 2008-09-17 |
| ELECSYS FREE PSA (P000027/S007) | Roche Diagnostics Corp. | 2008-09-17 |
| VARIOUS FAMILIES OF PACEMAKERS (P980035/S112) | Medtronic, Inc. | 2008-09-17 |
| CONCERTO/MAXIMO II/CONSULTA (P010031/S118) | Medtronic Cardiac Rhythm Disease Management | 2008-09-17 |
| VARIOUS FAMILIES OF ICDS (P980016/S149) | Medtronic Cardiac Rhythm Disease Management | 2008-09-17 |
| RESTORE ULTRA IMPLANTABLE NEUROSTIMULATOR (P840001/S119) | Medtronic Neuromodulation | 2008-09-17 |
| VARIOUS FAMILIES OF PACEMAKERS (P990001/S043) | Medtronic, Inc. | 2008-09-17 |
| ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S013) | Medtronic, Inc. | 2008-09-16 |
| COLOPLAST TITAN INFLATABLE PENILE PROSTHESIS (P000006/S011) | Coloplast Corp. | 2008-09-16 |
| EVOLENCE COLLAGEN FILLER (P070013/S002) | Colbar Lifescience , Ltd. | 2008-09-15 |
| UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (P970034/S011) | Aaren Scientific | 2008-09-12 |
| SUTURE MEDIATED CLOSURE (SMC) SYSTEMS (P960043/S064) | Abbott Vascular, Inc. | 2008-09-12 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S057) | Cordis Corp. | 2008-09-12 |
| ANTERIOR CHAMBER INTRAOCULAR LENS (P010027/S001) | Aaren Scientific | 2008-09-12 |
| ALLERGAN SILICONE-FILLED BREAST IMPLANTS (P020056/S007) | Allergan | 2008-09-12 |
| SYNERGY FAMILY OF NEUROSTIMULATOR SYSTEMS (P840001/S111) | Medtronic Neuromodulation | 2008-09-12 |
| STARCLOSE VASCULAR CLOSURE SYSTEM (P050007/S011) | Abbott Vascular Devices | 2008-09-12 |
| SJM MASTER HP VALVED GRAFT WITH GELWEAVE VALSALVA (P810002/S063) | ABBOTT MEDICAL | 2008-09-12 |
| NC STORMER BALLOON DILATATION CATHETERS (P790017/S097) | Medtronic, Ireland | 2008-09-11 |
| SOLARGEN 2100S LASER (P970029/S012) | Cryolife, Inc. | 2008-09-11 |
| DRIVER AND MICRODRIVER CORONARY STENT SYSTEMS (P030009/S023) | Medtronic, Ireland | 2008-09-11 |
| DRIVER & MICRO-DRIVER CORONARY STENT SYSTEM (P030009/S026) | Medtronic, Ireland | 2008-09-11 |
| VARIOUS FAMILIES OF PACEMAKERS (P980035/S111) | Medtronic, Inc. | 2008-09-11 |
| DEFLUX INJECTABLE GEL (P000029/S049) | Palette Life Sciences | 2008-09-11 |
| ANEURX STENT GRAFT SYSTEM (P990020/S032) | Medtronic Vascular | 2008-09-11 |
| CONCEPTUS ESSURE SYSTEM (P020014/S020) | Bayer Pharma AG | 2008-09-11 |
| ATS MECHANICAL HEART VALVES (P990046/S018) | Medtronic Ats Medical, Inc. | 2008-09-11 |
| KAPPA 400 SR (P970012/S042) | Medtronic, Inc. | 2008-09-11 |
| VARIOUS FAMILIES OF PACEMAKERS (P980035/S110) | Medtronic, Inc. | 2008-09-10 |
| EPIC HF (P030054/S102) | ABBOTT MEDICAL | 2008-09-10 |
| KAPPA 400 DR/SR (P970012/S041) | Medtronic, Inc. | 2008-09-10 |
| CADENCE (P910023/S187) | ABBOTT MEDICAL | 2008-09-10 |
| VARIOUS FAMILIES OF ICDS (P980016/S148) | Medtronic Cardiac Rhythm Disease Management | 2008-09-10 |
| STAAR SURGICAL COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (P990013/S022) | Starr Surgical Co. | 2008-09-10 |
| PROGRAMMER APPLICATION SOFTWARE PACKAGE VERSION SMARTVIEW 2.02 UG4 FOR ORCHESTRA AND ORCHESTRA PLUS PROGRAMMERS (P980049/S037) | MicroPort CRM USA, Inc. | 2008-09-10 |
| CADENCE FAMILY OF ICDS (P910023/S186) | ABBOTT MEDICAL | 2008-09-10 |
| INSYNC CRT-D/CONCERTO/CONSULTA/MAXIMO II & VARIOUS INSYNC FAMILIES OF ICDS (P010031/S117) | Medtronic Cardiac Rhythm Disease Management | 2008-09-10 |
| STAAR SURGICAL IMPLANTABLE COLLAMER LENS FOR MYOPIA (P030016/S009) | STAAR Surgical Company | 2008-09-10 |
| STAAR SURGICAL AQUAFLOW COLLAGEN GLAUCOMA DRAINAGE DEVICE (P000026/S001) | Starr Surgical Co. | 2008-09-10 |
| CORDIS PRECISE NITINOL STENT SYSTEM (P030047/S012) | Cordis US Corporation | 2008-09-10 |
| VARIOUS FAMILIES OF PACEMAKERS (P990001/S042) | Medtronic, Inc. | 2008-09-10 |
| PROMOTE FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (P030054/S101) | ABBOTT MEDICAL | 2008-09-10 |
| GEM & GEM II VR (P900061/S078) | Medtronic Cardiac Rhythm Disease Management | 2008-09-10 |
| GEM II AT (P980050/S036) | Medtronic, Inc. | 2008-09-10 |
| OVATIO CRT-D SYSTEM (P060027/S001) | MicroPort CRM USA, Inc. | 2008-09-10 |
| CHORUS PACEMAKERS (P900022/S011) | MicroPort CRM USA, Inc. | 2008-09-10 |
| VARIOUS FAMILIES OF PACEMAKERS (P950029/S036) | MicroPort CRM USA, Inc. | 2008-09-10 |
| STAAR SURGICAL ELASTIC/ELASTIMIDE & ELASTIC TORIC ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (P880091/S028) | Staar Surgical Co. | 2008-09-10 |
| INSYNC PULSE GENERATOR; INSYNC III (P010015/S051) | Medtronic, Inc. | 2008-09-10 |
| AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S166) | ABBOTT MEDICAL | 2008-09-09 |
| SWEDISH ADJUSTABLE GASTRIC BAND (P070009/S001) | Obtech Medical GmbH | 2008-09-09 |
| CADENCE FAMILY OF ICDS (P910023/S184) | ABBOTT MEDICAL | 2008-09-09 |
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S060) | St. Jude Medical, Inc. | 2008-09-09 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S027) | ABBOTT MEDICAL | 2008-09-09 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S024) | Medtronic, Inc. | 2008-09-09 |
| EPIC HF/ATLAS + HF FAMILY OF CRT-DS (P030054/S099) | ABBOTT MEDICAL | 2008-09-09 |
| FRONTIER/FRONTIERII FAMILY OF CRT-PS (P030035/S045) | ABBOTT MEDICAL | 2008-09-09 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S005) | Abbott Vascular, Inc. | 2008-09-09 |
| MEDTRONIC HALL PROSTHETIC HEART VALVE (P790018/S049) | Medtronic Cardiac Surgery | 2008-09-09 |
| XIENCE V RX EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S004) | Abbott Vascular, Inc. | 2008-09-05 |
| AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS,MODEL ADAPT (P060022) | Bausch & Lomb, Inc. | 2008-09-05 |
| CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (P030002/S017) | Bausch & Lomb, Inc. | 2008-09-05 |
| LATITUDE COMMUNICATOR SOFTWARE & SYSTEM SOFTWARE MODELS: 6482 AND 6488 (P910077/S091) | Boston Scientific | 2008-09-05 |
| NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S047) | Cochlear Americas | 2008-09-05 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S055) | Boston Scientific Corp | 2008-09-05 |
| MAXIMO II DR/VR (P980016/S147) | Medtronic Cardiac Rhythm Disease Management | 2008-09-04 |
| EPIC HF / ATLAS + FAMILY OF CRT-DS (P030054/S103) | ABBOTT MEDICAL | 2008-09-04 |
| STAAR SURGICAL COLLAMER UV ¿ ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (P030016/S010) | STAAR Surgical Company | 2008-09-04 |
| MAXIMO II CRT-D (P010031/S116) | Medtronic Cardiac Rhythm Disease Management | 2008-09-04 |
| COBAS TAQMAN HBV TEST (P050028) | Roche Molecular Systems, Inc. | 2008-09-04 |
| CADENCE FAMILY OF ICDS (P910023/S188) | ABBOTT MEDICAL | 2008-09-04 |
| STAAR SURGICAL COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (P990013/S023) | Starr Surgical Co. | 2008-09-04 |
| TALENT THORACIC STENT GRAFT SYSTEM (P070007/S002) | Medtronic Vascular | 2008-09-03 |
| MULTI-LINK VISION OTW FAMILY OF CORONARY STENT SYSTEMS (P020047/S012) | Abbott Vascular | 2008-09-03 |
| MULTI-LINK OTW ZETA CORONARY STENT SYSTEMS (P970020/S052) | Abbott Vascular, Inc. | 2008-09-03 |
| SYNCHROMED II INFUSION SYSTEM (P860004/S100) | Medtronic, Inc. | 2008-09-03 |
| GEM 21S (GROWTH ENHANCED MATRIX) (P040013/S012) | Lynch Biologics, LLC | 2008-09-03 |
| UROLOGIX TARGIS SYSTEM (P970008/S038) | Urologix, LLC | 2008-09-02 |
| MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) (P020031/S003) | Microsulis Medical , Ltd. | 2008-09-02 |
| COAPTITE INJECTABLE IMPLANT (P040047/S008) | Merz North America, Inc. | 2008-09-02 |
| MEDTRONIC SELECTSECURE MODEL 3830 LEAD (P030036/S008) | Medtronic Cardiac Rhythm Disease Management | 2008-08-29 |
| ACUITY STEERABLE FAMILY OF LEADS (P050046/S003) | Guidant Corp. | 2008-08-29 |
| NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S046) | Cochlear Americas | 2008-08-29 |
| SUPARTZ (P980044/S008) | Seikagaku Corp. | 2008-08-29 |
| SJM MASTERS SERIES AORTIC VALVED GRAFT (MODEL CAVGJ), AND THE SJM MASTERS HP VALVED GRAFT (MODEL VAVGJ) (P810002/S067) | ABBOTT MEDICAL | 2008-08-29 |
| CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS MODELS 7000 AND 7000TFX (P860057/S029) | Edwards Lifesciences, LLC | 2008-08-29 |