| THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM (P860003/S049) | Therakos Development Limited | 2008-08-29 |
| GEM21S GROWTH FACTOR ENHANCED (P040013/S013) | Lynch Biologics, LLC | 2008-08-29 |
| EASYTRAK 3 IS-1 & LV-1 (P010012/S190) | Boston Scientific Corp | 2008-08-29 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENTS (P020026/S056) | Cordis Corp. | 2008-08-28 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S003) | Abbott Vascular, Inc. | 2008-08-28 |
| MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM (P980022/S032) | Medtronic Minimed | 2008-08-28 |
| CONTAK RENEWAL 3 RF AND LIVIAN FAMILIES OF CRT-D (P010012/S188) | Boston Scientific Corp | 2008-08-28 |
| VIRTUOSO DR/VR/ENTRUST DR/VR/MAXIMO DR/VR/INTRINSIC DR (P980016/S135) | Medtronic Cardiac Rhythm Disease Management | 2008-08-28 |
| CONCERTO/INSYNC SENTRY/INSYNC MAXIMO (P010031/S104) | Medtronic Cardiac Rhythm Disease Management | 2008-08-28 |
| SOFLEX POSTERIOR CHAMBER INTRAOCULAR LENS (P910061/S014) | Bausch & Lomb | 2008-08-28 |
| ACRYSOF TORIC INTRAOCULAR LENSES (P930014/S027) | Alcon Laboratories, Inc. | 2008-08-28 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S052) | Boston Scientific Corp | 2008-08-27 |
| POWERLINK SYSTEM (P040002/S020) | Endologix, LLC | 2008-08-27 |
| COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S036) | Med-El Corp. | 2008-08-27 |
| ACRYSOF POSTERIOR CHAMBER INTRAOCULAR LENSES (P930014/S026) | Alcon Laboratories, Inc. | 2008-08-27 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S049) | Boston Scientific Corp | 2008-08-27 |
| AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST (P940040/S009) | Roche Molecular Systems, Inc. | 2008-08-26 |
| AMPLICOR HCV TEST (P000010/S012) | Roche Molecular Systems, Inc. | 2008-08-26 |
| COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST (P000012/S017) | Roche Molecular Systems, Inc. | 2008-08-26 |
| COBAS AMPLICOR HCV TEST (P000012/S016) | Roche Molecular Systems, Inc. | 2008-08-26 |
| LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM (P000008/S012) | Medtimo, Inc. | 2008-08-26 |
| PRODISC L TOTAL DISC REPLACEMENT (P050010/S003) | Centinel Spine, LLC | 2008-08-26 |
| FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S007) | Abbott Laboratories | 2008-08-25 |
| STARCLOSE AND STARCLOSE SE VASCULAR CLOSURE SYSTEMS (P050007/S009) | Abbott Vascular Devices | 2008-08-25 |
| THE GYNECARE THERMACHOICE* III (P970021/S022) | Gynecare, Inc. | 2008-08-25 |
| RESTYLANE INJECTABLE GEL (P040024/S027) | Q-Med AB | 2008-08-22 |
| HEALON D (P880031/S014) | Abbott Medical Optics, Inc. | 2008-08-22 |
| COLOPLAST TITAN INFLATABLE PENILE PROSTHESIS (P000006/S010) | Coloplast Corp. | 2008-08-22 |
| INSYNC SENTRY FAMILY/INSYNC II/III MARQUIS/INSYNC II/III PROTECT/INSYNC MAXIMO FAMILY/CONCERTO (P010031/S112) | Medtronic Cardiac Rhythm Disease Management | 2008-08-22 |
| MAXIMO/MAXIMO II DR/VR/MARQUIS/INTRINSIC/ENTRUST/VIRTUOSO (P980016/S143) | Medtronic Cardiac Rhythm Disease Management | 2008-08-22 |
| ADATO SIL-OL 5000 SILICONE OIL (P910071/S012) | Bausch & Lomb | 2008-08-22 |
| ENRHYTHM (P980035/S105) | Medtronic, Inc. | 2008-08-22 |
| VOYAGER NC CORONARY DILATATION CATHETER (P810046/S226) | Advanced Cardiovascular Systems, Inc. | 2008-08-21 |
| CONTAK RENEWAL & LIVIAN FAMILY OF CRT-DS (P010012/S187) | Boston Scientific Corp | 2008-08-21 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S054) | Boston Scientific Corp | 2008-08-21 |
| THE GYNECARE THERMACHOICE* III (P970021/S021) | Gynecare, Inc. | 2008-08-21 |
| VITALITY HE & CONFIENT ICDS (P960040/S173) | Boston Scientific | 2008-08-21 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S023) | W. L. Gore & Associates, Inc. | 2008-08-20 |
| CYPHER SIROLIMUS-ELUTING CORONARY SYSTEM (P020026/S055) | Cordis Corp. | 2008-08-20 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S042) | Boston Scientific Corp | 2008-08-20 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S057) | Boston Scientific Corp | 2008-08-19 |
| EPIC HF CRT-D SYSTEM (P030054/S100) | ABBOTT MEDICAL | 2008-08-19 |
| CADENCE ICD SYSTEM (P910023/S185) | ABBOTT MEDICAL | 2008-08-19 |
| COSEAL SURGICAL SEALANT (P030039/S010) | Baxter Bio Science | 2008-08-18 |
| VIRTUOSO (P980016/S121) | Medtronic Cardiac Rhythm Disease Management | 2008-08-18 |
| SYNERGY AND PRIME FAMILIES OF IMPLANTABLE NEUROSTIMULATORS (P840001/S107) | Medtronic Neuromodulation | 2008-08-18 |
| INTERSTIM II NEUROSTIMULATOR (P970004/S050) | Medtronic Neuromodulation | 2008-08-18 |
| CONCERTO (P010031/S091) | Medtronic Cardiac Rhythm Disease Management | 2008-08-18 |
| SYNCHROMED II IMPLANTABLE INFUSION PUMP (P860004/S097) | Medtronic, Inc. | 2008-08-18 |
| KINETRA NEUROSTIMULATOR (P960009/S047) | Medtronic, Inc. | 2008-08-18 |
| INFUSE BONE GRAFT (P050053/S005) | Medtronic, Inc. | 2008-08-15 |
| INFUSE BONE GRAFT (P000054/S015) | Medtronic Sofamor Danek USA, Inc. | 2008-08-15 |
| SECURA DR/VR & MAXIMO II DR/VR (P980016/S142) | Medtronic Cardiac Rhythm Disease Management | 2008-08-15 |
| CONSULTA CRT-D & MAXIMO II CRT-D (P010031/S111) | Medtronic Cardiac Rhythm Disease Management | 2008-08-15 |
| INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S026) | Medtronic Sofamor Danek USA, Inc. | 2008-08-15 |
| EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR (P850035/S032) | Ahp Eos Buyer, Inc. | 2008-08-15 |
| EBI OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATOR (P790005/S045) | Ahp Eos Buyer, Inc. | 2008-08-15 |
| OXFORD PARTIAL KNEE (P010014/S021) | Biomet Manufacturing Corp | 2008-08-15 |
| TELIGEN HE (P960040/S172) | Boston Scientific | 2008-08-14 |
| C-SERIES & T-SERIES (P990001/S038) | Medtronic, Inc. | 2008-08-14 |
| CORDIS PRECISE RX NITINOL STENT SYSTEM & PRECISE PRO RX NITINOL STENT SYSTEM (P030047/S014) | Cordis US Corporation | 2008-08-14 |
| CONCERTO (P010031/S110) | Medtronic Cardiac Rhythm Disease Management | 2008-08-14 |
| EVOLENCE COLLAGEN DERMAL FILLER (P070013/S001) | Colbar Lifescience , Ltd. | 2008-08-14 |
| VIRTUOSO (P980016/S141) | Medtronic Cardiac Rhythm Disease Management | 2008-08-14 |
| ENRHYTHM (P980035/S104) | Medtronic, Inc. | 2008-08-14 |
| COGNIS HE (P010012/S186) | Boston Scientific Corp | 2008-08-14 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S007) | W. L. Gore & Associates, Inc. | 2008-08-14 |
| PROLIEVE THERMODILITATION SYSTEM (P030006/S019) | Medifocus, Inc. | 2008-08-13 |
| ARTEFILL (P020012/S003) | Tiger Aesthetics Medical, LLC | 2008-08-13 |
| ACCESS HYBRITECH FREE PSA ASSAY (P970038/S012) | Beckman Coulter, Inc. | 2008-08-13 |
| SCULPTRA (P030050/S003) | Q-Med AB | 2008-08-13 |
| MONOPREP PAP TEST (P040052/S005) | Hologic, Inc. | 2008-08-11 |
| CARDIOWEST TEMPORARY TOTAL ARTIFICAL HEART (TAH-T) SYSTEM (P030011/S003) | Syncardia Systems, LLC | 2008-08-11 |
| PRODISC C TOTAL DISC REPLACEMENT (P070001/S002) | Centinel Spine, LLC | 2008-08-11 |
| ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER (P010020/S010) | Boston Scientific Corp | 2008-08-08 |
| STAAR SURGICAL ELASTIC/ELASTIMIDE/ELASTIC TORIC ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (P880091/S027) | Staar Surgical Co. | 2008-08-08 |
| SPRINT QUATTRO LEAD (P920015/S047) | Medtronic, Inc. | 2008-08-08 |
| ATTAIN STARFIX LEAD (P060039/S001) | Medtronic, Inc. | 2008-08-08 |
| AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S017) | Boston Scientific Corp | 2008-08-08 |
| ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S012) | Medtronic, Inc. | 2008-08-08 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S023) | Medtronic, Inc. | 2008-08-07 |
| S.M.A.R.T CONTROL NITINOL STENT SYSTEM (P020036/S010) | Cordis US Corporation | 2008-08-07 |
| MOSAIC PORCINE BIOPROSTHESIS (P990064/S025) | Medtronic, Inc. | 2008-08-07 |
| VASCULAR SOLUTIONS DUETT SEALING DEVICE (P990037/S026) | Vascular Solutions, Inc. | 2008-08-07 |
| NATRELLE SILICONE-FILLED BREAST IMPLANTS (P020056/S006) | Allergan | 2008-08-06 |
| FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S006) | Abbott Laboratories | 2008-08-06 |
| CIBA VISION LOTRAFILCON B & A SOFT CONTACT LENSES (P010019/S010) | Alcon Laboratories, Inc. | 2008-08-06 |
| RESTYLANE INJECTABLE GEL (P040024/S018) | Q-Med AB | 2008-08-06 |
| INSYNC III CRT-P (P010015/S039) | Medtronic, Inc. | 2008-08-04 |
| ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S026) | Boston Scientific Corp | 2008-08-04 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM & RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S053) | Cordis Corp. | 2008-08-04 |
| ENRHYTHM IPG (P980035/S088) | Medtronic, Inc. | 2008-08-04 |
| SECURA DR/VR & MAXIMO II DR/VR (P980016/S139) | Medtronic Cardiac Rhythm Disease Management | 2008-08-01 |
| EXPRESS/EXPRESS2 CORONARY STENT SYSTEM (P020009/S045) | Boston Scientific Scimed, Inc. | 2008-08-01 |
| LIBERTE CORONARY STENT SYSTEM (P040016/S032) | Boston Scientific Scimed, Inc. | 2008-08-01 |
| HEALON, HEALON GV & HEALON5 SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (P810031/S035) | Johnson & Johnson Surgical Vision, Inc. | 2008-08-01 |
| CONSULTA CRT-D & MAXIMO II CRT-D (P010031/S108) | Medtronic Cardiac Rhythm Disease Management | 2008-08-01 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S057) | Boston Scientific Corp | 2008-08-01 |
| SJM LEADS (P960030/S021) | ABBOTT MEDICAL | 2008-07-31 |
| QUICKSITE AND QUICKFLEX FAMILY OF LEADS (P030054/S079) | ABBOTT MEDICAL | 2008-07-31 |