| GEM MODEL 7227 IMPLANTABLE DEVICE (P890055/S021) | Intera Oncology | 2007-09-07 |
| ACRYSOF RESTOR APODIZED DIFFRACTIVE ASPHERIC INTRAOCULAR LENS (IOL) (P040020/S004) | Alcon Research, Ltd. | 2007-09-06 |
| ACRYSOF SINGLE-PIECE INTRAOCULAR LENS (IOL) (P930014/S020) | Alcon Laboratories, Inc. | 2007-09-06 |
| RIATA STS OPTIM LEAD MODELS 7120, 7121,7122,7130 AND 7131 (P950022/S040) | ABBOTT MEDICAL | 2007-09-06 |
| IN MOTION ARTIFICIAL DISC (P040006/S004) | Depuy Spine, Inc. | 2007-09-05 |
| PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA (P950042/S004) | Novadaq Technologies, Inc. | 2007-09-05 |
| VNS THERAPY SYSTEM (P970003/S087) | LivaNova USA, Inc. | 2007-09-04 |
| CYPHER SIROLIMUS ELUTING CORONARY STENT (P020026/S040) | Cordis Corp. | 2007-09-04 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S027) | W. L. Gore & Associates, Inc. | 2007-09-04 |
| DURALOC OPTION CERAMIC HIP SYSTEM (P040023/S009) | DePuy Orthopaedics, Inc. | 2007-09-03 |
| PHILOS AND AXIOS FAMILY OF PULSE GENERATORS (P950037/S051) | Biotronik, Inc. | 2007-08-31 |
| MONOPREP PAP TEST (P040052/S004) | Hologic, Inc. | 2007-08-31 |
| FIRE STAR RX PTCA BALLOON DILATATION CATHETER (P880003/S090) | Cordis Corp. | 2007-08-31 |
| MICRO-DRIVER CORONARY STENT SYSTEM (MX2 & OTW) (P030009/S014) | Medtronic, Ireland | 2007-08-30 |
| ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM (P020018/S016) | Cook, Inc. | 2007-08-30 |
| COBAS AMPLICOR HCV TEST VERSION 2.0 (P000012/S013) | Roche Molecular Systems, Inc. | 2007-08-30 |
| VISCOAT, DUOVISC AND DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICES (P840064/S032) | Alcon Laboratories | 2007-08-30 |
| GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATATION CATHETER (NC STORMER OTW & NC STORMER MX2) (P790017/S092) | Medtronic, Ireland | 2007-08-30 |
| THINPREP 2000 SYSTEM (P950039/S018) | Hologic, Inc. | 2007-08-30 |
| THINPREP IMAGING SYSTEM (P020002/S003) | Hologic, Inc. | 2007-08-30 |
| S-SERIES CORONARY STENT SYSTEMS (P970035/S047) | Medtronic, Ireland | 2007-08-30 |
| PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (P890047/S019) | Alcon Research, Ltd. | 2007-08-30 |
| SOFT ACRYLIC INTRAOCULAR LENSES (IOLS) (P960028/S023) | Johnson & Johnson Surgical Vision, Inc. | 2007-08-30 |
| HEALON,HEALON GV, & HEALON5 SODIUM HYALURONATE VISCOELASTIC (P810031/S033) | Johnson & Johnson Surgical Vision, Inc. | 2007-08-30 |
| VNS THERAPY SYSTEM (P970003/S086) | LivaNova USA, Inc. | 2007-08-30 |
| SOFT ACRYLIC INTRAOCULAR LENSES (IOLS) (P990080/S026) | Johnson & Johnson Surgical Vision, Inc. | 2007-08-30 |
| AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST (P940040/S007) | Roche Molecular Systems, Inc. | 2007-08-30 |
| AMPLICOR HCV TEST VERSION 2.0 (P000010/S009) | Roche Molecular Systems, Inc. | 2007-08-30 |
| OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S006) | Biomet Manufacturing Corp | 2007-08-30 |
| DRIVER CORONARY STENT SYSTEMS (P030009/S015) | Medtronic, Ireland | 2007-08-30 |
| GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATION CATHETER, NC STORMER MX2 (P790017/S091) | Medtronic, Ireland | 2007-08-30 |
| SOFT ACRYLIC INTRAOCULAR LENSES (IOLS) (P980040/S017) | Johnson & Johnson Surgical Vision, Inc. | 2007-08-30 |
| ONGUARD (P000041/S006) | Riverain Medical Group | 2007-08-30 |
| HANCOCK II BIOPROSTHESIS (P980043/S012) | Medtronic, Inc. | 2007-08-29 |
| MOSAIC PORCINE BIOPROSTHESIS (P990064/S018) | Medtronic, Inc. | 2007-08-29 |
| DURA STAR RX PTCA BALLOON DILATATION CATHETER (P880003/S089) | Cordis Corp. | 2007-08-29 |
| SPRINTER OVER THE WIRE (OTW) & SPRINTER MULTI-EXCHANGE (MX2) BALLOON DILATATION CATHETER (P790017/S088) | Medtronic, Ireland | 2007-08-29 |
| DRIVER RAPID EXCHANGE (RX) CORONARY STENT SYSTEMS (P030009/S009) | Medtronic, Ireland | 2007-08-29 |
| PORT-A-CATH EPIDURAL & PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS (P900052/S014) | Smiths Medical Asd, Inc. | 2007-08-28 |
| PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY (P970055/S006) | Diasorin | 2007-08-24 |
| PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY (P970054/S006) | Diasorin | 2007-08-24 |
| NEXSTENT CAROTID STENT AND MONORAIL DELIVERY SYSTEM (P050025/S006) | Boston Scientific | 2007-08-24 |
| CONTAK RENEW 3 RF (P010012/S151) | Boston Scientific Corp | 2007-08-24 |
| CODMAN 3000 IMPLANTABLE INFUSION PUMP (P890055/S020) | Intera Oncology | 2007-08-23 |
| CELSIUS,CELSIUS II, CELSIUS RMT, EZ STEER, EZ STEER DS DIAGNOSTIC/ABLATION CATHETERS (P950005/S021) | Biosense Webster, Inc. | 2007-08-23 |
| EUFLEXXA (P010029/S004) | Ferring Pharmaceuticals, Inc. | 2007-08-23 |
| NAVISTAR RMT DS CATHETER (P010068/S010) | Biosense Webster, Inc. | 2007-08-23 |
| NAVISTAR 4 MM BI DIRECTIONAL DIAGNOSTIC/ABLATION CATHETER (P990025/S013) | Biosense Webster, Inc. | 2007-08-23 |
| LAP BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM (P000008/S010) | Medtimo, Inc. | 2007-08-22 |
| INAMED SILICONE-FILLED BREAST IMPLANTS (P020056/S001) | Allergan | 2007-08-22 |
| SALINE FILLED BREAST IMPLANTS (P990074/S017) | Allergan | 2007-08-22 |
| SPRINTER OVER-THE-WIRE BALLOON DILATATION CATHETER (P790017/S087) | Medtronic, Ireland | 2007-08-22 |
| TENDRIL FAMILY OF LEADS (P960013/S030) | ABBOTT MEDICAL | 2007-08-21 |
| SAFIRE TX CARDIAC ABLATION CATHETER AND INTERFACE CABLES (P040042/S009) | Irvine Biomedical,Inc.(Ibi) | 2007-08-21 |
| INTACS PRESCRIPTION INSERTS (P980031/S007) | Addition Technology | 2007-08-21 |
| FEMORAL INTRODUCER SHEATH AND HEMOSTASIS (FISH) DEVICE 5,6, AND 8 FRENCH (P050043) | Morris Innovative Research, Inc. | 2007-08-20 |
| CADENCE ICDS (P910023/S145) | ABBOTT MEDICAL | 2007-08-17 |
| EPIC HF CRT-DS (P030054/S060) | ABBOTT MEDICAL | 2007-08-17 |
| GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATATION CATHETER (P790017/S086) | Medtronic, Ireland | 2007-08-17 |
| EPIC HF CRT-DS (P030054/S062) | ABBOTT MEDICAL | 2007-08-17 |
| LIFEVEST WCD 3000 (P010030/S009) | Zoll Manufacturing Corporation | 2007-08-17 |
| CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM (P010001/S004) | Ceramtec GmbH | 2007-08-17 |
| CADENCE ICDS (P910023/S146) | ABBOTT MEDICAL | 2007-08-17 |
| NEXSTENT STENT AND MONORAIL DELIVERY SYSTEM (P050025/S005) | Boston Scientific | 2007-08-17 |
| EPIC HF CRT-DS (P030054/S061) | ABBOTT MEDICAL | 2007-08-17 |
| CADENCE ICDS (P910023/S144) | ABBOTT MEDICAL | 2007-08-17 |
| AMPLATZER SEPTAL OCCLUDER (P000039/S019) | ABBOTT MEDICAL | 2007-08-16 |
| ATS OPEN PIVOT BILEAFLET HEART VALVES (P990046/S013) | Medtronic Ats Medical, Inc. | 2007-08-16 |
| HEALON, HEALON GV AND HEALON5 SODIUM HYLAURONATE OPHTHALMIC VISCOELASTIC DEVICES (P810031/S031) | Johnson & Johnson Surgical Vision, Inc. | 2007-08-16 |
| EXOGEN 4000+BONE HEALING SYSTEM (P900009/S027) | Bioventus, LLC | 2007-08-16 |
| EXOGEN 4000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) (P900009/S028) | Bioventus, LLC | 2007-08-16 |
| RELIANCE ACTIVE FIX & RELIANCE PASSIVE FIX STERIOD ELUTING ENDOCARDIAL DEFIBRILLATION LEADS (P910073/S067) | Boston Scientific | 2007-08-15 |
| VISTAKON (SENOFILCON A) CONTACT LENS MATERIAL (P040045/S001) | Vistakon, Division of Johnson & Johnson Vision Car | 2007-08-14 |
| LCS TOTAL KNEE SYSTEM-RPF FEMORAL COMPONENT LINE EXTENSION (P830055/S099) | Depuy, Inc. | 2007-08-14 |
| REFLECTION CERAMIC ACETABULAR SYSTEM (P030022/S003) | Smith & Nephew, Inc. | 2007-08-14 |
| MODEL 5388 EXTERNAL PULSE GENERATOR (P820003/S080) | Medtronic Cardiac Rhythm Disease Management | 2007-08-10 |
| CONTAK RENEWAL TR (P030005/S044) | Guidant Corp. | 2007-08-10 |
| GEM 21S (GROWTH ENHANCED MATRIX) (P040013/S009) | Lynch Biologics, LLC | 2007-08-10 |
| ENTRUST 30J & 35J ICD & VIRTUOSO DR & VR ICD (P980016/S104) | Medtronic Cardiac Rhythm Disease Management | 2007-08-10 |
| CONCERTO CRT-D (P010031/S072) | Medtronic Cardiac Rhythm Disease Management | 2007-08-10 |
| PEPGEN P-15, PEPGEN P-15 FLOW & PEPGEN P-15 PUTTY (P990033/S014) | Ceramed Corp. | 2007-08-09 |
| AMS UROLUME ENDOPROSTHESIS (P920023/S022) | Boston Scientific Corp | 2007-08-08 |
| HTA SYSTEM (P000040/S010) | Axora Medical, Inc. | 2007-08-08 |
| MEDTRONIC ENTRUST 35J ICD (D154ATG, D15DRG. D154VRC) MEDTRONIC VIRTUOSO ICD (D154AWG, D154VWC) (P980016/S099) | Medtronic Cardiac Rhythm Disease Management | 2007-08-07 |
| CONCERTO (C154DWK) (P010031/S067) | Medtronic Cardiac Rhythm Disease Management | 2007-08-07 |
| CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S014) | Bayer Pharma AG | 2007-08-07 |
| VENTAK PRX/MINI ICD SYSTEM (P910077/S053) | Boston Scientific | 2007-08-06 |
| RENEWAL TR (P030005/S022) | Guidant Corp. | 2007-08-06 |
| CONTAK RENEWAL CD (P010012/S078) | Boston Scientific Corp | 2007-08-06 |
| TENDRIL FAMILY OF LEADS (P960013/S029) | ABBOTT MEDICAL | 2007-08-06 |
| PRIZM/ VITALITY (P960040/S088) | Boston Scientific | 2007-08-06 |
| DISCOVERY/MERIDIAN (P940031/S046) | Boston Scientific | 2007-08-06 |
| THERMATRX TMX-3000 OFFICE THERMOTHERAPY SYSTEM (P000043/S019) | Boston Scientific Corp | 2007-08-03 |
| LATITUDE PATIENT MANAGEMENT SYSTEM MODEL 6481 INDUCTIVE COMMUNICATOR (P910077/S075) | Boston Scientific | 2007-08-03 |
| OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S005) | Biomet Manufacturing Corp | 2007-08-03 |
| PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEM (P060001/S003) | Medtronic Vascular, Inc. | 2007-08-02 |
| EXABLATE 2000, VERSION 4.22 (P040003/S004) | Insightec, Ltd. | 2007-08-02 |
| ANGIOJET RHELYTIC THROMBECTOMY SYSTEM (P980037/S023) | Boston Scientific Corp | 2007-08-02 |
| AMPLATZER SEPTAL OCCLUDER (P000039/S021) | ABBOTT MEDICAL | 2007-08-02 |
| ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS & CALIBRATORS (P030029/S001) | Siemens Healthcare Diagnostics | 2007-08-02 |