| LIBERTE MR & OTW CORONARY STENT SYSTEM (P040016/S015) | Boston Scientific Scimed, Inc. | 2006-09-21 |
| LIBERTE MR & OTW CORONARY STENT SYSTEMS (P040016/S013) | Boston Scientific Scimed, Inc. | 2006-09-21 |
| EPIC II/II + DR/VR & ATLAS II/II + DR/VR ICDS (P910023/S116) | ABBOTT MEDICAL | 2006-09-21 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S015) | W. L. Gore & Associates, Inc. | 2006-09-21 |
| TAXUS EXPRESS 2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S034) | Boston Scientific Corp | 2006-09-21 |
| AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER ? ?CRIBRIFORM? OCCLUDER (P000039/S013) | ABBOTT MEDICAL | 2006-09-21 |
| LIBERTE MR & OTW CORONARY STENT SYSTEM (P040016/S014) | Boston Scientific Scimed, Inc. | 2006-09-21 |
| LOTRAFILCON A AND LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR (P010019/S004) | Alcon Laboratories, Inc. | 2006-09-20 |
| DURALOC OPTION CERAMIC HIP SYSTEM (P040023/S006) | DePuy Orthopaedics, Inc. | 2006-09-20 |
| VIFILCON A SOFT CONTACT LENSES FOR EXTENDED WEAR (P820021/S031) | Alcon Laboratories, Inc. | 2006-09-20 |
| THERAPY DUAL 8 CATHETER AND IBI-1500T6 CARDIAC ABLATION GENERATOR (P040042/S004) | Irvine Biomedical,Inc.(Ibi) | 2006-09-20 |
| COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P810006/S022) | Integra LifeSciences Corporation | 2006-09-20 |
| RX ACCULINK & ACCULINK CAROTID STENT SYSTEMS (P040012/S019) | Abbott Vascular | 2006-09-20 |
| HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S019) | Integra LifeSciences Corporation | 2006-09-20 |
| COLLACOTE ABSORBABLE COLLAGEN WOUND DRESSING (P840062/S009) | Integra Lifesciences Corp. | 2006-09-20 |
| ESSURE PERMANENT BIRTH CONTROL SYSTEM (P020014/S013) | Bayer Pharma AG | 2006-09-19 |
| SELECTED FAMILIES OF ICDS (P980016/S083) | Medtronic Cardiac Rhythm Disease Management | 2006-09-19 |
| KAPPA 600/700/800/900 & ENPULSE FAMILIES OF PACEMAKERS (P980035/S061) | Medtronic, Inc. | 2006-09-19 |
| VARIOUS INSYNC FAMILIES OF CRT-ICDS (P010031/S050) | Medtronic Cardiac Rhythm Disease Management | 2006-09-19 |
| MODEL 2490H MEDTRONIC CARELINK MONITOR & MODEL 2020A CARDIOSIGHT READER (P890003/S108) | Medtronic, Inc. | 2006-09-19 |
| HOUSECALL PLUS WITH TRANSMITTER SOFTWARE VERSION 3.0, RECEIVER SOFTWARE VERSION 3.0 AND TRANSMITTER HARDWARE VERSION H (P910023/S115) | ABBOTT MEDICAL | 2006-09-18 |
| SYMPHONY 2550 AND 2250 & RHAPSODY 2530, 2510 AND 2210 (P950029/S028) | MicroPort CRM USA, Inc. | 2006-09-15 |
| SYMPHONY & ELA RHAPSODY DEVICES (P950029/S027) | MicroPort CRM USA, Inc. | 2006-09-15 |
| PRIZM FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY DEVICES (CRT-D) (P960040/S125) | Boston Scientific | 2006-09-15 |
| RENEWAL (P010012/S129) | Boston Scientific Corp | 2006-09-15 |
| AMPLATZER DUCT OCCLUDER (P020024/S012) | ABBOTT MEDICAL | 2006-09-15 |
| AMPLATZER SEPTAL OCCLUDER (P000039/S017) | ABBOTT MEDICAL | 2006-09-15 |
| MERIDIAN, MODELS 976,1176, 1276 (P940031/S054) | Boston Scientific | 2006-09-15 |
| DURASEAL DURAL SEALANT SYSTEM (P040034/S005) | Integra LifeSciences Corporation | 2006-09-15 |
| SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (P810031/S028) | Johnson & Johnson Surgical Vision, Inc. | 2006-09-14 |
| DERMABOND TOPICAL SKIN ADHESIVE (P960052/S012) | Closure Medical Corp. | 2006-09-14 |
| SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (P810031/S029) | Johnson & Johnson Surgical Vision, Inc. | 2006-09-13 |
| MEDTRONIC GEM III AT WITH APP DEVICE MODEL 7276 AND SOFTWARE MODEL9974 (P980050/S024) | Medtronic, Inc. | 2006-09-13 |
| SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (P810031/S030) | Johnson & Johnson Surgical Vision, Inc. | 2006-09-13 |
| VITROS IMMUNODIAGNOSTIC PRODUCT ANTI-HBC IGM REAGENT PACK & CALIBRATOR (P030026/S011) | Ortho-Clinical Diagnostics, Inc. | 2006-09-12 |
| ABBOTT AXSYM AUSAB (P060003/S001) | Abbott Laboratories, Inc. | 2006-09-11 |
| AXSYM CORE 2.0 AND AXSYM CORE 2.0 CONTROLS (P060012) | Abbott Laboratories, Inc. | 2006-09-08 |
| GEM 21S GROWTH FACTOR ENHANCED MATRIX (P040013/S006) | Lynch Biologics, LLC | 2006-09-08 |
| CORDIS CYPHER SIROLIMUS ELUTING CORONARY STENT (P020026/S021) | Cordis Corp. | 2006-09-07 |
| 36 MM DIAMETER ZENITH FLEX AAA ENDOVASCULAR GRAFT (P020018/S010) | Cook, Inc. | 2006-09-07 |
| S.M.A.R.T. CONTROL NITINOL STENT SYSTEM (P020036/S005) | Cordis US Corporation | 2006-09-07 |
| ARCHITECT HBSAG REAGENT KIT, CALIBRATORS, CONTROLS, CONFIRMATORY REAGENT KIT, CONFIRMATORY MANUAL DILUENT (P060007) | Abbott Laboratories | 2006-09-07 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK, CALIBRATOR, CONFIRMATORY KIT (P000044/S014) | Ortho-Clinical Diagnostics, Inc. | 2006-09-06 |
| NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM (P970003/S070) | LivaNova USA, Inc. | 2006-09-05 |
| PATHWAY HER-2/NEU (CLONE CB11) PRIMARY ANTIBODY (P990081/S004) | Ventana Medical Systems, Inc. | 2006-09-05 |
| MOSIAC PORCINE BIOPROSTHESIS, MODELS 305, 310 (P990064/S016) | Medtronic, Inc. | 2006-09-01 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS, MODELS 995, 995MS AND 995CS (P970031/S017) | Medtronic, Inc. | 2006-09-01 |
| DEXCOM SHORT TERM GLUCOSE SENSOR (STS) (P050012/S003) | Dexcom, Inc. | 2006-09-01 |
| SENOGRAPHE ESSENTIAL SYSTEM (P990066/S024) | GE Healthcare | 2006-09-01 |
| RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS (P040012/S023) | Abbott Vascular | 2006-09-01 |
| HANCOCK II PORCINE BIOPROSTHESIS, MODELS T505 AND T510 (P980043/S010) | Medtronic, Inc. | 2006-09-01 |
| IMMULITE / IMMULITE 1000 HBSAG & IMMULITE 2000 HBSAG (P010050/S005) | Siemens Healthcare Diagnostics Products, Ltd. | 2006-09-01 |
| KAPPA 400 SERIES (P970012/S024) | Medtronic, Inc. | 2006-08-31 |
| INSYNC 8040 DEVICE, INSYNC III 8042.8044 DEVICES (P010015/S024) | Medtronic, Inc. | 2006-08-31 |
| MEDTRONIC CARELINK MONITOR MODEL 2490C AND MODEL 2491 DDMA DEVICES (P890003/S102) | Medtronic, Inc. | 2006-08-31 |
| MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL (P970004/S037) | Medtronic Neuromodulation | 2006-08-31 |
| VIRTUOSO MODELS D154AWG/ D154VWC IMPLANTABLE DEVICES (P010031/S048) | Medtronic Cardiac Rhythm Disease Management | 2006-08-31 |
| CONCERTO MODEL C154DWK (P010031/S040) | Medtronic Cardiac Rhythm Disease Management | 2006-08-31 |
| MEDTRONIC CARELINK MONITOR MODEL 2490C AND MODEL 2491 DMA SOFTWARE (P980016/S073) | Medtronic Cardiac Rhythm Disease Management | 2006-08-31 |
| KAPPA 600/650/700 , KAPPA 800/900 MODELS (P980035/S059) | Medtronic, Inc. | 2006-08-31 |
| THERA/THERA-I PRODIGY SERIES (P890003/S107) | Medtronic, Inc. | 2006-08-31 |
| CONCERTO MODEL C154DWK IMPLANTABLE DEVICES (P980016/S081) | Medtronic Cardiac Rhythm Disease Management | 2006-08-31 |
| VARIOUS FAMILIES OF PACEMAKERS (P890003/S098) | Medtronic, Inc. | 2006-08-30 |
| VARIOUS FAMILIES OF PACEMAKERS (P820003/S077) | Medtronic Cardiac Rhythm Disease Management | 2006-08-30 |
| EZ STEER AND EZ STEER DS BIDIRECTIONAL DIAGNOSTIC/ABLATION CATHETERS (P950005/S019) | Biosense Webster, Inc. | 2006-08-29 |
| NAVISTAR DS BI-DIRECTIONAL DIAGNOSTIC/ABLATION CATHETER (P010068/S006) | Biosense Webster, Inc. | 2006-08-29 |
| FREESTYLE AORTIC ROOT BIOPROTHESIS MODEL 995 (P970031/S015) | Medtronic, Inc. | 2006-08-28 |
| HEALON,HEALON GV AND HEALON5 SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (P810031/S027) | Johnson & Johnson Surgical Vision, Inc. | 2006-08-28 |
| CONTAK TR CARDIAC RESYNCHRONIZATION THERAPY SYSTEMS (P030005/S035) | Guidant Corp. | 2006-08-25 |
| PRIZM, PRIZM HE, PRIZM 2, VITALITY, VITALITY 2, VITALITY AVT, VITALITY DS, VITALITY EL, VITALITY HE (P960040/S127) | Boston Scientific | 2006-08-25 |
| MOSAIC PORCINE BIOPROSTHESIS (P990064/S015) | Medtronic, Inc. | 2006-08-25 |
| CONTAK RENEWAL, CONTAK RENEWAL 3, CONTAK RENEWAL 3 RF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR SYSTEMS (P010012/S131) | Boston Scientific Corp | 2006-08-25 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S025) | Cordis Corp. | 2006-08-25 |
| AXSYM CORE-M 2.0 AND AXSYM CORE-M 2.0 CONTROLS (P060009) | Abbott Laboratories, Inc. | 2006-08-25 |
| DISCOVERY/ MERIDIAN (P940031/S055) | Boston Scientific | 2006-08-25 |
| MONOLISA ANTI-HBS EIA (P050048) | Bio-Rad Laboratories | 2006-08-25 |
| SUPARTZ (P980044/S004) | Seikagaku Corp. | 2006-08-25 |
| MEDTRONIC CARELINK MONITOR MODEL 2490H VERSION A07801 REVISION C (P980035/S058) | Medtronic, Inc. | 2006-08-24 |
| ACRYSOF INTRAOCULAR LENSES (IOLS) (P930014/S018) | Alcon Laboratories, Inc. | 2006-08-24 |
| PMMA ANTERIOR CHAMBER IOLS (P880087/S012) | Alcon Laboratories | 2006-08-24 |
| AMVISC & AMVISC PLUS (P810025/S026) | Bausch & Lomb, Inc. | 2006-08-24 |
| PMMA MULTI-PIECE POSTERIOR CHAMBER VS100 IOLS (P810032/S052) | Alcon Laboratories | 2006-08-24 |
| PMMA SINGLE-PIECE POSTERIOR CHAMBER IOLS (P840060/S030) | Alcon Laboratories | 2006-08-24 |
| ACRYSOF RESTOR APODIZED DIFFRACTIVE IOLS (P040020/S002) | Alcon Research, Ltd. | 2006-08-24 |
| MEDTRONIC CARELINK MONITOR MODEL 2490H VERSION A07801 REVISION C (P890003/S106) | Medtronic, Inc. | 2006-08-24 |
| STAARVISC II AND SHELLGEL SODIUM HYALURONATE (P000046/S014) | Anika Therapeutics, Inc. | 2006-08-24 |
| COLOPLAST SALINE-FILLED TESTICULAR PROSTHESIS (P020003/S004) | Coloplast Corp. | 2006-08-23 |
| FLEXTOME CUTTING BALLOON MONORAIL DEVICE (P950020/S018) | Boston Scientific Corp | 2006-08-22 |
| GEM 21S GROWTH FACTOR ENHANCED MATRIX (P040013/S005) | Lynch Biologics, LLC | 2006-08-21 |
| DEXCOM STS SYSTEM (P050012/S002) | Dexcom, Inc. | 2006-08-21 |
| HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM (P000040/S007) | Axora Medical, Inc. | 2006-08-18 |
| MIRCO-DRIVER OVER-THE -WIRE(OTW) CORONARY STENT SYSTEM & MX2 CORONARY STENT SYSTEM (P030009/S005) | Medtronic, Ireland | 2006-08-17 |
| CONCERTO CRT-D (P010031/S046) | Medtronic Cardiac Rhythm Disease Management | 2006-08-17 |
| CONCERTO CRT-D (P010031/S047) | Medtronic Cardiac Rhythm Disease Management | 2006-08-17 |
| ENTRUST AND VIRTUOSO ICDS (P980016/S080) | Medtronic Cardiac Rhythm Disease Management | 2006-08-17 |
| HARMONY HIRESOLUTION BIONIC EAR SYSTEM (P960058/S049) | Advanced Bionics | 2006-08-17 |
| ACCULINK & RX ACCULINK CAROTID STENT SYSTEM (P040012/S022) | Abbott Vascular | 2006-08-17 |
| ENTRUST AND VIRTUOSO ICDS (P980016/S078) | Medtronic Cardiac Rhythm Disease Management | 2006-08-17 |
| FRONTIER II BIVENTRICULAR PACING SYSTEMS (P030035/S018) | ABBOTT MEDICAL | 2006-08-16 |
| CONCERTO CRT-D (P010031/S045) | Medtronic Cardiac Rhythm Disease Management | 2006-08-16 |