| INTERSTIM THERAPY FOR URINARY CONTROL (P970004/S043) | Medtronic Neuromodulation | 2007-10-15 |
| TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM (P990040/S005) | Cerenovus, Inc. | 2007-10-15 |
| RESTYLANE INJECTABLE GEL (P040024/S013) | Q-Med AB | 2007-10-12 |
| REFLECTION CERAMIC ACETABULAR HIP SYSTEM (P030022/S006) | Smith & Nephew, Inc. | 2007-10-12 |
| EPIC HF CRT-DS (P030054/S068) | ABBOTT MEDICAL | 2007-10-12 |
| CADENCE ICDS (P910023/S155) | ABBOTT MEDICAL | 2007-10-12 |
| VNS THERAPY SYSTEM (P970003/S089) | LivaNova USA, Inc. | 2007-10-11 |
| QUANTIFERON TB GOLD IN TUBE (P010033/S011) | Qiagen | 2007-10-10 |
| PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY (P970055/S005) | Diasorin | 2007-10-10 |
| PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY (P970054/S005) | Diasorin | 2007-10-10 |
| COLOPLAST SALINE-FILLED TESTICULAR IMPLANT (P020003/S005) | Coloplast Corp. | 2007-10-09 |
| ONYX LIQUID EMBOLIC SYSTEM (P030004/S003) | Ev3 Neurovascular | 2007-10-09 |
| AMPLATZER SEPTAL OCCLUDER & MULTI-FENESTRATED SEPTAL OCCLUDER (P000039/S022) | ABBOTT MEDICAL | 2007-10-05 |
| INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S023) | Medtronic Sofamor Danek USA, Inc. | 2007-10-05 |
| EPIC HF/ATLAS+HF FAMILY OF CRT-DS (P030054/S064) | ABBOTT MEDICAL | 2007-10-05 |
| AMPLATZER DUCT OCCLUDER (P020024/S016) | ABBOTT MEDICAL | 2007-10-05 |
| INFUSE BONE GRAFT (P000054/S011) | Medtronic Sofamor Danek USA, Inc. | 2007-10-05 |
| WALLSTENT ILIAC ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P940019/S021) | Boston Scientific Scimed, Inc. | 2007-10-05 |
| CADENCE FAMILY OF ICDS (P910023/S151) | ABBOTT MEDICAL | 2007-10-05 |
| INFUSE BONE GRAFT (P050053/S002) | Medtronic, Inc. | 2007-10-05 |
| CARELINK PROGRAMMER, MODEL 2090 (P890003/S125) | Medtronic, Inc. | 2007-10-04 |
| INSYNC SENTRY & MAXIMO USED WITH SOFTWARE APPLICATION, MODELS 7297 AND 7299 (P010031/S076) | Medtronic Cardiac Rhythm Disease Management | 2007-10-04 |
| X-STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM (P040001/S007) | Medtronic Sofamor Danek, Inc. | 2007-10-04 |
| ELEVESS (P050033/S005) | Anika Therapeutics, Inc. | 2007-10-03 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S090) | Boston Scientific Corp | 2007-10-03 |
| MACROPLASTIQUE IMPLANTS (P040050/S002) | Uroplasty, LLC | 2007-10-03 |
| HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S026) | Integra LifeSciences Corporation | 2007-10-03 |
| COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P810006/S029) | Integra LifeSciences Corporation | 2007-10-03 |
| COLLACOTE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P840062/S015) | Integra Lifesciences Corp. | 2007-10-03 |
| BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S004) | Smith & Nephew, Inc. | 2007-10-01 |
| GEM 21S GROWTH-FACTOR ENHANCED MATRIX (P040013/S011) | Lynch Biologics, LLC | 2007-10-01 |
| CONTRAK CD/EASYTRAK (P010012/S156) | Boston Scientific Corp | 2007-09-28 |
| SBI BRAUN-CUTTER TRAPEZ-METACARPAL PROSTHESIS (P960053/S004) | Stryker Corporation | 2007-09-28 |
| CADENCE ICD'S (P910023/S153) | ABBOTT MEDICAL | 2007-09-28 |
| REALIZE ADJUSTABLE GASTRIC BAND MODEL 2200-X (P070009) | Obtech Medical GmbH | 2007-09-28 |
| CRT-D'S (P030054/S066) | ABBOTT MEDICAL | 2007-09-28 |
| VENTAK AV/VR (VENTAK PRIZM) (P960040/S149) | Boston Scientific | 2007-09-28 |
| MODELS 5348 AND 5388 EXTERNAL PULSE GENERATORS (P820003/S081) | Medtronic Cardiac Rhythm Disease Management | 2007-09-28 |
| VOYAGER OTW CORONARY DILATATION CATHETER (P810046/S222) | Advanced Cardiovascular Systems, Inc. | 2007-09-27 |
| ARISTA AH ABSORBABLE HEMOSTAT (P050038/S003) | Davol, Inc. | 2007-09-27 |
| STAN S31 FETAL HEART MONITOR (P020001/S002) | Neoventa Medical AB | 2007-09-26 |
| CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (P030002/S012) | Bausch & Lomb, Inc. | 2007-09-26 |
| MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S027) | Med-El Corp. | 2007-09-25 |
| ZENITH AAA ENDOVASCULAR GRAFT WITH H&L ONE SHOT INTRODUCTION SYSTEM (P020018/S022) | Cook, Inc. | 2007-09-25 |
| SAFIRE CARDIAC ABLATION SYSTEM (P960016/S019) | St Jude Medical | 2007-09-24 |
| COMBO 40+ COCHLEAR IMPLANT SYSTEM (P000025/S023) | Med-El Corp. | 2007-09-24 |
| VNS THERAPY PULSE & PULSE DUO GENERATORS (P970003/S088) | LivaNova USA, Inc. | 2007-09-21 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S043) | Cochlear Americas | 2007-09-21 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S044) | Cochlear Americas | 2007-09-21 |
| CADENCE FAMILY OF ICD'S (P910023/S152) | ABBOTT MEDICAL | 2007-09-21 |
| VIRTUOSO (P980016/S107) | Medtronic Cardiac Rhythm Disease Management | 2007-09-21 |
| NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S041) | Cochlear Americas | 2007-09-21 |
| INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S017) | Integra Lifesciences Corp. | 2007-09-21 |
| CONCERTO CARDIAC RESYNCHRONIZATION THERAPY DEVICES (CRT-DS) (P010031/S077) | Medtronic Cardiac Rhythm Disease Management | 2007-09-21 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S001) | W. L. Gore & Associates, Inc. | 2007-09-21 |
| COOL CAP SYSTEM (P040025/S005) | Natus Medical Incorporated | 2007-09-21 |
| CORDIS CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S041) | Cordis Corp. | 2007-09-21 |
| RESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY CATHETER (P020052/S004) | St Jude Medical | 2007-09-21 |
| RESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY CATHETER (P020052/S003) | St Jude Medical | 2007-09-21 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S042) | Cochlear Americas | 2007-09-21 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S006) | W. L. Gore & Associates, Inc. | 2007-09-21 |
| EPIC HF FAMILY OF CRT-D'S (P030054/S065) | ABBOTT MEDICAL | 2007-09-21 |
| MYNX VASCULAR CLOSURE DEVICE (P040044/S002) | Cordis US Corporation | 2007-09-20 |
| CORDIS S.M.A.R.T. NITINOL STENT SYSTEM & S.M.A.R.T. CONTROL NITINOL STENT SYSTEM (P020036/S008) | Cordis US Corporation | 2007-09-20 |
| CORDIS PRECISE NITINOL & RX NITINOL & PRO RX NITINOL STENT SYSTEM (P030047/S005) | Cordis US Corporation | 2007-09-20 |
| PRIZM, PRIZM II CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-D) (P960040/S143) | Boston Scientific | 2007-09-19 |
| VOYAGER RX CORONARY DILATATION CATHETER (P810046/S223) | Advanced Cardiovascular Systems, Inc. | 2007-09-19 |
| BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES (P980006/S011) | Bausch & Lomb, Inc. | 2007-09-19 |
| ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P970038/S009) | Beckman Coulter, Inc. | 2007-09-19 |
| VOYAGER OTW CORONARY DILATATION CATHETER (P810046/S224) | Advanced Cardiovascular Systems, Inc. | 2007-09-19 |
| ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P850048/S022) | Beckman Coulter, Inc. | 2007-09-18 |
| KAPPA 900 (P980035/S075) | Medtronic, Inc. | 2007-09-18 |
| INSYNC III (P010015/S031) | Medtronic, Inc. | 2007-09-18 |
| KAPPA 400 (P970012/S028) | Medtronic, Inc. | 2007-09-18 |
| PRESTIGE CERVICAL DISC (P060018/S001) | Medtronic Sofamor Danek, Inc. | 2007-09-18 |
| THERA/PRODIGY (P890003/S124) | Medtronic, Inc. | 2007-09-18 |
| CARELINK MONITOR MODELS 2490G, 2490H, 2490J, AND THE 2020A CARDIOSIGHT READER (P900061/S071) | Medtronic Cardiac Rhythm Disease Management | 2007-09-14 |
| KAPPA, ENPULSE & ADAPTA PACEMAKERS (P980035/S069) | Medtronic, Inc. | 2007-09-14 |
| MARQUIS, MAXIMO & ENTRUST ICDS (P980016/S092) | Medtronic Cardiac Rhythm Disease Management | 2007-09-14 |
| VARIOUS PACEMAKERS, CARELINK MONITORS, CARDIOSIGHT READER (P890003/S114) | Medtronic, Inc. | 2007-09-14 |
| DIMENSION FPSA FLEX REAGENT CARTRIDGE (P020027/S006) | Siemens Healthcare Diagnostics | 2007-09-14 |
| INSYNC MARQUIS, SENTRY, MAXIMO CRT-ICDS (P010031/S059) | Medtronic Cardiac Rhythm Disease Management | 2007-09-14 |
| DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S010) | Siemens Healthcare Diagnostics | 2007-09-14 |
| BIOLON 1% SODIUM HYALURONATE (P960011/S011) | Altacor , Ltd. | 2007-09-13 |
| MEDTRONIC ICD MODEL INSYNC 7272 SYSTEM (P010031/S073) | Medtronic Cardiac Rhythm Disease Management | 2007-09-13 |
| VIRTUOSO (P980016/S105) | Medtronic Cardiac Rhythm Disease Management | 2007-09-12 |
| ADATO SIL-OL 5000 SILICONE OIL (P910071/S009) | Bausch & Lomb | 2007-09-12 |
| OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S016) | Biomet Manufacturing Corp | 2007-09-12 |
| CONCERTO (P010031/S074) | Medtronic Cardiac Rhythm Disease Management | 2007-09-12 |
| CONCERTO CARDIAC RESYNCHRONIZATION THERAPY DEVICES (CRT-DS) (P010031/S075) | Medtronic Cardiac Rhythm Disease Management | 2007-09-12 |
| VIRTUOSO FAMILY OF DEVICES (P980016/S106) | Medtronic Cardiac Rhythm Disease Management | 2007-09-12 |
| ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S009) | Beckman Coulter, Inc. | 2007-09-12 |
| MODEL 2490G/H/J MEDTRONIC CARELINK MONITOR AND THE MODEL 2020A CARDIOSIGHT READER (P900061/S073) | Medtronic Cardiac Rhythm Disease Management | 2007-09-11 |
| VARIOUS FAMILIES OF PACEMAKERS (P890003/S126) | Medtronic, Inc. | 2007-09-11 |
| CURRENT ICD'S (P030054/S050) | ABBOTT MEDICAL | 2007-09-11 |
| VARIOUS FAMILIES OF ICDS (P980016/S108) | Medtronic Cardiac Rhythm Disease Management | 2007-09-11 |
| INSYNC FAMILY & CONCERTO CRT-ICDS (P010031/S078) | Medtronic Cardiac Rhythm Disease Management | 2007-09-11 |
| VARIOUS FAMILIES OF PACEMAKERS (P980035/S076) | Medtronic, Inc. | 2007-09-11 |
| PROMOTE MODELS 3207-36 AND 3207-30 (P910023/S132) | ABBOTT MEDICAL | 2007-09-11 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040) | ABBOTT MEDICAL | 2007-09-07 |