| AFFINITY ANTERIOR CERVICAL CAGE SYSTEM (P000028/S004) | Medtronic Sofamor Danek USA, Inc. | 2003-11-13 |
| OSTEONICS ABC SYSTEM AND TRIDENT SYSTEM (P000013/S003) | Howmedica Osteonics Corp. | 2003-11-13 |
| INDERMIL TISSUE ADHESIVE (P010002/S004) | Covidien Lp, Formerly Registered AS United States | 2003-11-12 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM WITH CONTOUR ADVANCE (P970051/S025) | Cochlear Americas | 2003-11-07 |
| HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST AND HYBRID CAPTURE HPV DNA TEST (P890064/S013) | Qiagen Gaithersburg, Inc. | 2003-11-07 |
| VIEWPOINT CK SYSTEM (P010018/S003) | Refractec, Inc. | 2003-11-06 |
| HOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM WITH MODEL 3180-T TRANSMITTER (SOFTWARE VERSION 1.1) AND MODEL 3180-R (P910023/S071) | ABBOTT MEDICAL | 2003-11-06 |
| IMX HAVAB -M (LIST NUMBER 2263) (P790019/S017) | Abbott Laboratories | 2003-11-06 |
| PHOSPHORYLCHOLINE (PC) COATED BIODIVYSIO SV AND OC OVER-THE-WIRE (OTW) STENT DELIVERY SYSTEMS (P000011/S010) | Abbott Vascular, Inc. | 2003-11-05 |
| INTACS PRESCRIPTION INSERTS (P980031/S006) | Addition Technology | 2003-11-05 |
| ENDOTAK RELIANCE G AND SG ENDOCARDIAL DEFIBRILLATION LEAD (P910073/S041) | Boston Scientific | 2003-11-04 |
| SOFTWARE APPLICATION MODEL 2890 VERSION 4.10 (P940031/S028) | Boston Scientific | 2003-10-31 |
| SYNCHRONY MODEL 2020T PULSE GENERATOR (P880086/S097) | ABBOTT MEDICAL | 2003-10-31 |
| MODEL 3510 PROGRAMMER AND MODEL 3134 EXTERNAL VIDEO CABLE (P830045/S089) | St. Jude Medical, Inc. | 2003-10-31 |
| ICAD SYSTEM (P010038/S005) | Icad, Inc. | 2003-10-31 |
| BAK VISTA INTERBODY FUSION CAGE (P950002/S012) | Zimmer Spine, Inc. | 2003-10-31 |
| CARDIAC AIRBAG ICD, 345-424, CARDIAC AIRBAG-T ICD, 341-517, A-K00.1.U. PROGRAMMER SOFTWARE, 346-168 (P980023/S015) | Biotronik, Inc. | 2003-10-31 |
| SECOND LOOK ANALOG 6.0 COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY (P010034/S004) | Icad, Inc. | 2003-10-31 |
| THORATEC HEARTMATE XVE LVAS (P920014/S021) | Thoratec Corp | 2003-10-31 |
| 7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM (P020045/S002) | Medtronic Cryocath, LP | 2003-10-28 |
| EXPRESS/EXPRESS2 CORONARY STENT SYSTEM (P020009/S011) | Boston Scientific Scimed, Inc. | 2003-10-28 |
| PREPSTAIN SYSTEM (P970018/S005) | Bd Diagnostic Systems | 2003-10-27 |
| APLIGRAF (P950032/S036) | Organogenesis, Inc. | 2003-10-24 |
| SYMPHONY/ELA RHAPSODY PACEMAKER SYSTEM (P950029/S017) | MicroPort CRM USA, Inc. | 2003-10-24 |
| NIRFLEX PREMOUNTED STENT (P020040) | Medinol, Ltd. | 2003-10-24 |
| CONTAK RENEWAL AND CONTAK RENEWAL 3 (P010012/S016) | Boston Scientific Corp | 2003-10-24 |
| EXPRESS AND EXPRESS2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS (P020009/S012) | Boston Scientific Scimed, Inc. | 2003-10-24 |
| NOVOSTE BETA-CATH SYSTEM (P000018/S027) | Best Vascular, Inc. | 2003-10-23 |
| MEDTRONIC MARQUIS DR 7274.MARQUIS VR 7230,MAXIMO DR 7278,MAXIMO VR 7232 (P980016/S038) | Medtronic Cardiac Rhythm Disease Management | 2003-10-23 |
| INSYNC MARQUIS MODEL 7277 AND THE INSYNC II MARQUIS MODEL 7289 (P010031/S010) | Medtronic Cardiac Rhythm Disease Management | 2003-10-23 |
| MORCHER CAPSULAR TENSION RING, TYPES 14, 14A AND 14C (P010059) | Morcher GmbH | 2003-10-23 |
| NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM (P970003/S048) | LivaNova USA, Inc. | 2003-10-22 |
| VITALITY AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS AND MODEL 2857 SOFTWARE, VERSION 1.6 (P960040/S032) | Boston Scientific | 2003-10-22 |
| ROTAWIRE FLOPPY GOLD GUIDE WIRE (P900056/S078) | Boston Scientific Corp | 2003-10-22 |
| ORCHESTRA PROGRAMMER (P980049/S011) | MicroPort CRM USA, Inc. | 2003-10-21 |
| CONTAK CD (MODEL 1823), CONTAK CD2 (MODEL H115, H119), RENEWAL (MODELS H135) AND RENEWAL 3 (MODELS H170,H175,H177,H179) (P010012/S014) | Boston Scientific Corp | 2003-10-21 |
| INTERCEED (TC7) ABSORBABLE ADHESION BARRIER (P880047/S008) | ETHICON, Inc. | 2003-10-21 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER (P020026/S001) | Cordis Corp. | 2003-10-21 |
| ATLAS+ DR/BR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND MODEL 3307 V.4.5A SOFTWARE (P910023/S069) | ABBOTT MEDICAL | 2003-10-17 |
| ATLAS+ DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, AND MODEL 3307 V.4.5A SOFTWARE (P830045/S088) | St. Jude Medical, Inc. | 2003-10-17 |
| QUANTUM MAVERICK MONORAIL AND OVER-THE-WIRE PTCA CATHETERS (P860019/S195) | Scimed Life Systems, Inc. | 2003-10-17 |
| ATLAS+ DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND MODEL 3307 V.4.5A SOFTWARE (P880086/S096) | ABBOTT MEDICAL | 2003-10-17 |
| COROMETRICS MODEL 120 F-SERIES MATERNAL/FETAL MONITOR WITH INTERGRATED FETAL OXYGEN SATURATION MONITORING (P000016/S002) | Ge Medical Systems Information Technologies | 2003-10-15 |
| GORE EXCLUDER BIFURCATED ENDOPROSTHESIS (P020004/S004) | W. L. Gore & Associates, Inc. | 2003-10-15 |
| TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESIS SYSTEM AND TMJ FOSSA-EMINENCE PROSTHESIS (P000035/S004) | Nexus CMF, LLC | 2003-10-14 |
| NOVOSTE BETA-CATH SYSTEM (P000018/S038) | Best Vascular, Inc. | 2003-10-14 |
| ORCHESTRA PROGRAMMER (P980049/S010) | MicroPort CRM USA, Inc. | 2003-10-14 |
| BELOS AND CARDIAC AIRBAG FAMILIES (P000009/S010) | Biotronik, Inc. | 2003-10-14 |
| TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESIS SYSTEM AND TMJ FOSSA-EMINENCE PROSTHESIS (P000023/S004) | Nexus CMF, LLC | 2003-10-14 |
| BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION (P990027/S006) | Technolas Perfect Vision GmbH | 2003-10-10 |
| ICAD SYSTEM (P010038/S004) | Icad, Inc. | 2003-10-10 |
| RAY TFC UNITE (P950019/S016) | Stryker Spine | 2003-10-10 |
| SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P010025/S003) | Hologic, Inc. | 2003-10-10 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER (P020026/S003) | Cordis Corp. | 2003-10-10 |
| WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM (P030008) | Alcon Laboratories, Inc. | 2003-10-10 |
| DIMENSION FPSA FLEX REAGENT CARTRIDGE (P020027/S001) | Siemens Healthcare Diagnostics | 2003-10-10 |
| NOVOSTE BETA-CATH SYSTEM (P000018/S037) | Best Vascular, Inc. | 2003-10-09 |
| NOVOSTE BETA-CATH SYSTEM (P000018/S036) | Best Vascular, Inc. | 2003-10-09 |
| BSD-500 HYPERTHERMIA SYSTEM (P820088/S016) | Pyrexar Medical, Inc. | 2003-10-08 |
| MULTI-LINK RX AND OTW VISION CORONARY STENT SYSTEMS (P020047/S001) | Abbott Vascular | 2003-10-08 |
| SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY (P010034/S005) | Icad, Inc. | 2003-10-08 |
| WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM (P020050) | Alcon Laboratories, Inc. | 2003-10-07 |
| MEDTRONIC MODEL 7278 MAXIMO DR ICD AND MODEL 7232 MAXIMO VR ICD SYSTEMS, WITH MODEL 9978 VERSION 1.0 APPLICATION SOFTWA (P980016/S037) | Medtronic Cardiac Rhythm Disease Management | 2003-10-06 |
| VENTAK VITALITY AVT AICD, MODELS A135 AND A155, MODEL 2920 PROGRAMMER WITH MODEL 2812 APPLICATION SOFTWARE VERSION 1.2 (P960040/S035) | Boston Scientific | 2003-10-06 |
| LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER (P960016/S013) | St Jude Medical | 2003-10-03 |
| MEDTRONIC AT500 DDDRP PACING SYSTEM (MODEL AT501) AND MODEL 9968 SOFTWARE (P980035/S028) | Medtronic, Inc. | 2003-10-03 |
| DRIVER OVER-THE-WIRE, RAPID EXCHANGE, AND MULTI-EXCHANGE CORONARY STENT SYSTEMS (P030009) | Medtronic, Ireland | 2003-10-01 |
| X-PRESS 6 FRENCH VASCULAR CLOSURE SYSTEM (P020035) | St. Jude Medical, Inc. | 2003-09-30 |
| NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM (P970003/S046) | LivaNova USA, Inc. | 2003-09-30 |
| ALERT SYSTEM-COMPANION II (P990069/S001) | Dot Medical Products , Ltd. | 2003-09-29 |
| SEPRAFLIM ADHESION BARRIER (P950034/S026) | Baxter Healthcare Corporation | 2003-09-29 |
| SYNVISC HYLAN G-F 20 (P940015/S006) | Sanofi Genzyme Corp. | 2003-09-26 |
| INSTAT ABSORBABLE COLLAGEN HEMOSTAT (P830079/S014) | ETHICON, Inc. | 2003-09-26 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM WITH CONTOUR SOFTIP ELECTRODE (P970051/S026) | Cochlear Americas | 2003-09-25 |
| SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P010025/S002) | Hologic, Inc. | 2003-09-24 |
| ABIOMED AB5000 CIRCULATORY SUPPORT SYSTEM (P900023/S038) | Abiomed Cardiovascular, Inc. | 2003-09-24 |
| ATS AVG (AORTIC VALVED GRAFT) (P990046/S009) | Medtronic Ats Medical, Inc. | 2003-09-23 |
| MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM (P020031) | Microsulis Medical , Ltd. | 2003-09-23 |
| CARBOMEDICS PROSTHETIC HEART VALVE (P900060/S027) | Corcym S.r.l. | 2003-09-23 |
| MEDTRONIC HALL PROSTHETIC HEART VALVES (MODELS A7700 AND M7700) (P790018/S044) | Medtronic Cardiac Surgery | 2003-09-23 |
| SYNERGYST II PULSE GENERATOR (P890003/S071) | Medtronic, Inc. | 2003-09-17 |
| MEDTRONIC MODEL 2490D/E CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE FOR INSYNC ICD, MODEL 7272 AND INSYNC MARQUIS, M (P010031/S007) | Medtronic Cardiac Rhythm Disease Management | 2003-09-17 |
| INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S006) | Medtronic Sofamor Danek USA, Inc. | 2003-09-17 |
| ITREL 3, SYNERGY AND SYNERGY VERSITREL (P840001/S070) | Medtronic Neuromodulation | 2003-09-17 |
| INTER FIX THREADED FUSION DEVICE (P970015/S025) | Sofamor Danek | 2003-09-17 |
| VITATRON DA+ C SERIES PULSE GENERATORS (P990001/S014) | Medtronic, Inc. | 2003-09-16 |
| HYDROVIEW COMPOSITE HYGROGEL FOLDABLE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR (IOL) (P990014/S004) | Bausch & Lomb, Inc. | 2003-09-16 |
| ATS MEDICAL HEART VALVE (P990046/S008) | Medtronic Ats Medical, Inc. | 2003-09-16 |
| APLIGRAF (P950032/S035) | Organogenesis, Inc. | 2003-09-15 |
| BIOMEDICS 38 (POLYMACON) UV BLOCKING CONTACT LENSES (P780007/S043) | CooperVision, Inc. | 2003-09-12 |
| LADARVISION 4000 EXCIMER LASER SYSTEM (P970043/S014) | Alcon Laboratories | 2003-09-12 |
| OSTEONICS ABC/TRIDENT SYSTEMS (P000013/S002) | Howmedica Osteonics Corp. | 2003-09-12 |
| SYNVISC HYLAN G-F 20 (P940015/S010) | Sanofi Genzyme Corp. | 2003-09-12 |
| SYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM (P860004/S056) | Medtronic, Inc. | 2003-09-12 |
| WALLSTENT VENOUS ENDOPROSTHESIS (P980033/S007) | Boston Scientific Corporation | 2003-09-11 |
| WALLSTENT LLIAC ENDOPROSTHESIS (P940019/S015) | Boston Scientific Scimed, Inc. | 2003-09-11 |
| WALLSTENT TIPS ENDOPROSTHESIS (P930031/S017) | Boston Scientific Corp | 2003-09-11 |
| IMAGE CHECKER M1000 SYSTEM (P970058/S016) | Hologic, Inc. | 2003-09-10 |
| LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE (P970015/S022) | Sofamor Danek | 2003-09-10 |
| HOME ACCESS HEPATITIS C CHECK TEST SERVICE (P980046/S006) | Pwn Health Chicago, LLC | 2003-09-08 |