| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBSAG REAGENT PACK AND CALIBRATOR (P000044/S004) | Ortho-Clinical Diagnostics, Inc. | 2004-11-04 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS (P930038/S041) | Terumo Medical Corporation | 2004-11-04 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR (P030026/S002) | Ortho-Clinical Diagnostics, Inc. | 2004-11-04 |
| VITROS IMMUNODIAGNOSTIC ANTI-HBS REAGENT PACK AND CALIBRATOR (P000014/S010) | Ortho-Clinical Diagnostics, Inc. | 2004-11-04 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATOR (P010021/S004) | Ortho-Clinical Diagnostics, Inc. | 2004-11-04 |
| COBAS AMPLICOR HCV TEST, VERSION 2.0 (P000012/S004) | Roche Molecular Systems, Inc. | 2004-11-04 |
| ANGIOLINK VASCULAR CLOSURE SYSTEM (P040022) | Medtronic Vascular | 2004-11-03 |
| DEFLUX INJECTABLE GEL (P000029/S010) | Palette Life Sciences | 2004-11-02 |
| DIAGNOSTIC RESTORATION TOOL (DRT) MODEL 2725, VERSION 2.2 (P960040/S046) | Boston Scientific | 2004-10-29 |
| PRISM/PRIZM 2/ CONTAK CD2/VITALITY DS/EL MODEL 2844 VERSION 3.8 (P010012/S033) | Boston Scientific Corp | 2004-10-29 |
| AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT(MCH) FLOUR (N17600/S021) | Davol Inc., Sub. C. R. Bard, Inc. | 2004-10-29 |
| ENDOLOGIX POWERLINK SYSTEM (P040002) | Endologix, LLC | 2004-10-29 |
| MODEL 2844 VERSION 3.8 (P960040/S047) | Boston Scientific | 2004-10-29 |
| AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (P800002/S014) | C.R. Bard, Inc. | 2004-10-29 |
| ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM (P990020/S017) | Medtronic Vascular | 2004-10-28 |
| SYMPHONY & ELA RHAPSODY PACEMAKERS (P950029/S021) | MicroPort CRM USA, Inc. | 2004-10-27 |
| DURASPHERE EXP (P980053/S007) | Carbon Medical Technologies, Inc. | 2004-10-27 |
| CHARITE ARTIFICIAL DISC (P040006) | Depuy Spine, Inc. | 2004-10-26 |
| INSYNC SENTRY MODEL 7297 ICD AND MODEL 9998 APPLICATION SOFTWARE VERSION 1.2 (P010031/S015) | Medtronic Cardiac Rhythm Disease Management | 2004-10-26 |
| 9F FREEZOR MAX SURGICAL CARDIAC CRYOABLATION DEVICE (P020045/S006) | Medtronic Cryocath, LP | 2004-10-26 |
| EPIC HF CRT-D (P030054/S003) | ABBOTT MEDICAL | 2004-10-25 |
| 2490D/E CARELINK MONITORS (P890003/S078) | Medtronic, Inc. | 2004-10-25 |
| EXABLATE 2000 SYSTEM (P040003) | Insightec, Ltd. | 2004-10-22 |
| OSTEONICS ABC/TRIDENT SYSTEMS (P000013/S005) | Howmedica Osteonics Corp. | 2004-10-22 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) (P030025/S006) | Boston Scientific Corp | 2004-10-21 |
| CRYOLIFE BIOGLUE SURGICAL ADHESIVE (P010003/S004) | Cryolife, Inc. | 2004-10-20 |
| GORE EXCLUDER BIFURCATED ENDOPROSTHESIS (P020004/S007) | W. L. Gore & Associates, Inc. | 2004-10-20 |
| INSYNC MAXIMO MODEL 7303 AND MODEL 9998 APPLICATION SOFTWARE, VERSION 1.2 (P010031/S017) | Medtronic Cardiac Rhythm Disease Management | 2004-10-19 |
| MODEL 2490G/ 2490H/2490J CARELINK MONITORS FOR USE WITH MODEL 2491 DDMA SOFTWARE (P890003/S077) | Medtronic, Inc. | 2004-10-19 |
| TMX-2000 BPH (P000043/S009) | Boston Scientific Corp | 2004-10-18 |
| UROLUME ENDOPROSTHESIS (P920023/S018) | Boston Scientific Corp | 2004-10-15 |
| SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T) (P030011) | Syncardia Systems, LLC | 2004-10-15 |
| CHILLI II COOLED ABLATION CATHETER (P980003/S013) | Boston Scientific Corp | 2004-10-14 |
| LCS TOTAL KNEE SYSTEM (P830055/S089) | Depuy, Inc. | 2004-10-14 |
| HYLAFORM PLUS (HYLAN B GEL) (P030032/S001) | Genzyme Biosurgery | 2004-10-13 |
| EPT-1000XP CARDIAC ABLATION SYSTEM (P020025/S007) | Boston Scientific | 2004-10-12 |
| GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (P940034/S016) | Gen-Probe, Inc. | 2004-10-08 |
| BAK/C VISTA CERVICAL INTERBODY FUSION DEVICE (P980048/S003) | Sulzer Spine-Tech | 2004-10-06 |
| NOVOSTE BETA - CATH SYSTEM (P000018/S041) | Best Vascular, Inc. | 2004-10-04 |
| STAT PACE II (P840002/S011) | Cardiocommand, Inc. | 2004-10-01 |
| PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S002) | Boston Scientific Corp | 2004-10-01 |
| KENTROX RV-S STEROID AND KENTROX SL-2 STEROID IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS (P980023/S017) | Biotronik, Inc. | 2004-09-30 |
| Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact (P040029) | Euclid Vision Corporation | 2004-09-29 |
| CRYSTALENS MODEL AT-45 MULTIPIECE SILICONE POSTERIOR CHAMBER ACCOMODATING INTRAOCULAR LENS (IOL) (P030002/S002) | Bausch & Lomb, Inc. | 2004-09-29 |
| ABBOTT AXSYM TOTAL PSA ASSAY (P910007/S011) | Abbott Laboratories | 2004-09-27 |
| O2 OPTIX (LOTRAFILCON B) AND NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES FOR EXTENDED WEAR (P010019/S003) | Alcon Laboratories, Inc. | 2004-09-27 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATS (P000014/S009) | Ortho-Clinical Diagnostics, Inc. | 2004-09-27 |
| HYDROGENICS 2.0 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR (P890023/S016) | The Cooper Companies | 2004-09-24 |
| ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM (P040012/S001) | Abbott Vascular | 2004-09-24 |
| DERMABOND TOPICAL SKIN ADHESIVE (P960052/S009) | Closure Medical Corp. | 2004-09-24 |
| PAFLUFOCON D RIGID GAS PERMEABLE CONTACT LENSES (P870024/S044) | CooperVision, Inc. | 2004-09-24 |
| MARQUIS VR, DR/MAXIMO/ MAXIMO DR/ INTRINSIC 30/INTRINSIC (P980016/S045) | Medtronic Cardiac Rhythm Disease Management | 2004-09-22 |
| KAPPA 700, 800, 900/SIGMA/ENPULSE (P980035/S039) | Medtronic, Inc. | 2004-09-22 |
| INSYNC MARQUIS/INSYNC III (MARQUIS)/INSYNC II (MARQUIS)/INSYNC II (PROTECT)/INSYNC MAXIMO/PRODIGY DR (P010031/S016) | Medtronic Cardiac Rhythm Disease Management | 2004-09-22 |
| VITATRON LEGACY 11 DR (P890003/S076) | Medtronic, Inc. | 2004-09-22 |
| MEDTRONIC KAPPA 400 SERIES PACEMAKERS (P970012/S016) | Medtronic, Inc. | 2004-09-22 |
| CELSION PROLIEVE THERMODILATATION SYSTEM (P030006/S002) | Medifocus, Inc. | 2004-09-17 |
| PROGRAMMER SOFTWARE A-K00.2.U IN THE LEXOS, BELOS AND CARDIAC AIRBAG IMPLANTABLE CARDIOVERTER DEFIBRILLATS (P000009/S013) | Biotronik, Inc. | 2004-09-17 |
| INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S012) | Integra Lifesciences Corp. | 2004-09-17 |
| RESTYLANE INJECTABLE GEL (P020023/S010) | Q-Med AB | 2004-09-17 |
| INSYNC 8040 DEVICES (P010015/S014) | Medtronic, Inc. | 2004-09-15 |
| MODEL 9879 SOFTWARE FOR THERA/THERA-I/PRODIGY DEVICES, MODEL 9849 SOFTWARE FOR THE LEGACY II/VISA DEVICES, MODEL 9847... (P890003/S075) | Medtronic, Inc. | 2004-09-15 |
| CONTAK CD (MODEL 1823), CONTAK CD 2 (MODELS H115 AND H119), RENEWAL (MODEL H135), RENEWAL 3 (MODELS H170, H175, H177, A (P010012/S026) | Boston Scientific Corp | 2004-09-14 |
| LEAD ADAPTERS MODEL NUMBER 6024 (P910073/S047) | Boston Scientific | 2004-09-13 |
| VITAGEL SURGICAL HEMOSTAT (P990030/S005) | Angiotech Medical Device Technologies | 2004-09-13 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS, MODELS 610130 AND 610131 (P930038/S040) | Terumo Medical Corporation | 2004-09-13 |
| THORATEC PVAD SYSTEM AND TLC-II PORTABLE VAD DRIVER (P870072/S029) | Thoratec Laboratories Corp. | 2004-09-13 |
| CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIK LOAD (P000049/S015) | Nmt Medical, Inc. | 2004-09-13 |
| MULTI-LINK VISION CORONARY STENT SYSTEM - 2.75 MM (P020047/S004) | Abbott Vascular | 2004-09-10 |
| ABBOTT ARCHITECT FREE PSA (P980007/S006) | Abbott Laboratories | 2004-09-10 |
| SUPARTZ (P980044/S002) | Seikagaku Corp. | 2004-09-10 |
| MULTI-LINK MINI VISION CORONARY STENT SYSTEM (P020047/S003) | Abbott Vascular | 2004-09-10 |
| GATED SUTURE TRIMMER ACCESSORY (P960043/S056) | Abbott Vascular, Inc. | 2004-09-10 |
| ABBOTT AXSYM FREE PSA ASSAY (P980007/S005) | Abbott Laboratories | 2004-09-10 |
| ARTISAN (MODEL 206 AND 204) PHAKIC INTRAOCULAR LENS (PIOL) VERISYSE (VRSM5US AND VRSM6US) PHAKIC INTRAOCULAR LENS (PIOL) (P030028) | Ophtec BV | 2004-09-10 |
| ABBOTT ARCHITECT TOTAL PSA (P910007/S012) | Abbott Laboratories | 2004-09-10 |
| OL1000, OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATORS (P910066/S019) | Djo, LLC | 2004-09-10 |
| NAVISTAR DS 8 MM DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER AND CELSIUS DS 8 MM DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER (P010068/S004) | Biosense Webster, Inc. | 2004-09-10 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S010) | Hologic, Inc. | 2004-09-09 |
| SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM (P010038/S008) | Icad, Inc. | 2004-09-01 |
| GEM III AT WITH APP DEVICE MODEL 7276 AND SOFTWARE MODEL 9974 (P980050/S016) | Medtronic, Inc. | 2004-08-31 |
| SURESTAT ARTERIAL CLOSURE SYSTEM (P010049/S012) | Sub-Q, Inc. | 2004-08-31 |
| ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM (P040012) | Abbott Vascular | 2004-08-30 |
| COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0 (P000012/S003) | Roche Molecular Systems, Inc. | 2004-08-30 |
| PERCLOSE PROGLIDE 6 FR. SUTURE-MEDIATED CLOSURE (SMC) SYSTEM (P960043/S055) | Abbott Vascular, Inc. | 2004-08-30 |
| EXTERNAL PULSE GENERATOR MODEL 2A, TAPSCOPE 500 SERIES ESOPHAGEAL STETHOSCOPE AND PACING CATHETER, TAPSCOPE 210 ESOPHAGR (P840002/S012) | Cardiocommand, Inc. | 2004-08-27 |
| EXTERNAL PULSE GENERATOR MODEL 2A, TAPSCOPE 500 SERIES ESOPHAGEAL STETHOSCOPE AND PACING CATHETER, TAPSCOPE 210 ESOPHAGR (P860008/S018) | Cardio Command | 2004-08-27 |
| INDEPENDENCE IBOT 3000 MOBILITY SYSTEM (P020033/S001) | Independence Technology, LLC | 2004-08-27 |
| MEDTRONIC MAXIMO VR MODELS 7232B AND 7232 IMPLANTABLE CARDIAC DEFIBRILLATORS (ICDS) (P980016/S044) | Medtronic Cardiac Rhythm Disease Management | 2004-08-25 |
| MEDTRONIC ENPULSE IMPLANTABLE PULSE GENERATOR AND MODEL 9991 APPLICATIONS SOFTWARE (P980035/S034) | Medtronic, Inc. | 2004-08-25 |
| HIRESOLUTION BIONIC EAR SYSTEM (P960058/S038) | Advanced Bionics | 2004-08-24 |
| AFFINITY ANTERIOR CERVICAL CAGE SYSTEM (P000028/S006) | Medtronic Sofamor Danek USA, Inc. | 2004-08-24 |
| GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM (P970021/S011) | Gynecare, Inc. | 2004-08-23 |
| LIVEWIRE TC CARDIAC ABLATION SYSTEM (P960016/S010) | St Jude Medical | 2004-08-20 |
| ENTERYX PROCEDURE KIT, MODEL M000572600 (P020006/S005) | Boston Scientific Corp | 2004-08-20 |
| MEDTRONIC LEFT VENTRICULAR PACING LEAD, ATTAIN BIPOLAR OTW MODEL 4194 (P010015/S012) | Medtronic, Inc. | 2004-08-20 |
| SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P030010) | Siemens Medical Solution | 2004-08-20 |
| TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) (P030025/S004) | Boston Scientific Corp | 2004-08-18 |
| MEDTRONIC INTRINSIC MODELS 7287 AND 7288 ICD SYSTEMS (P980016/S043) | Medtronic Cardiac Rhythm Disease Management | 2004-08-18 |
| CODMAN MODEL 3000 SERIES CONSTANT FLOW IMPLANTABLE PUMP (P890055/S017) | Intera Oncology | 2004-08-18 |