| GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM (P000052/S024) | Guidant Corp. | 2004-05-04 |
| ORCHESTRA PROGRAMMER (P980049/S015) | MicroPort CRM USA, Inc. | 2004-05-04 |
| DIGENE HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST (P890064/S014) | Qiagen Gaithersburg, Inc. | 2004-05-04 |
| LIFEVEST (WCD 3000S) WEARABLE DEFIBRILLATOR (P010030/S005) | Zoll Manufacturing Corporation | 2004-05-03 |
| FREEZOR CARDIAC CRYOABLATION CATHETER (P020045/S004) | Medtronic Cryocath, LP | 2004-05-03 |
| BIOGLUE SURGICAL ADHESIVE IN SYRINGE DELIVERY SYSTEM (MODEL BG3500) (P010003/S003) | Cryolife, Inc. | 2004-05-03 |
| DIASORIN ETI-MAK-2-PLUS (P990038/S006) | DiaSorin, Inc. | 2004-05-03 |
| DIASORIN ETI-CORE-IGMK PLUS (P990044/S005) | DiaSorin, Inc. | 2004-04-30 |
| DIASORIN ETI-MAK-2 PLUS (P990038/S007) | DiaSorin, Inc. | 2004-04-30 |
| DIASORIN ETI-EBK PLUS (P990043/S007) | DiaSorin, Inc. | 2004-04-30 |
| DIASORIN ETI-AB-EBK PLUS (P990041/S006) | DiaSorin, Inc. | 2004-04-30 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLATFORM AND ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS PLATFORM (P930038/S039) | Terumo Medical Corporation | 2004-04-30 |
| INFUSE BONE GRAFT (P000054) | Medtronic Sofamor Danek USA, Inc. | 2004-04-30 |
| DIASORIN ETI-AB-AUK PLUS (P990042/S007) | DiaSorin, Inc. | 2004-04-30 |
| DIASORIN ETI-AB-COREK PLUS (P990045/S006) | DiaSorin, Inc. | 2004-04-30 |
| ACRYSOF UV-ABSORBING SINGLE-PIECE PC IOL (P840060/S028) | Alcon Laboratories | 2004-04-29 |
| ACRYSOF UV-ABSORBING MULTI-PIECE PC IOL (P810032/S050) | Alcon Laboratories | 2004-04-29 |
| ACRYSOF SINGLE-PIECE POSTERIOR CHAMBER IOL (P930014/S014) | Alcon Laboratories, Inc. | 2004-04-29 |
| ACRYSOF UV-ABSORBING PMMA SINGLE-PIECE ANTERIOR CHAMBER (P880087/S010) | Alcon Laboratories | 2004-04-29 |
| NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM (P970003/S051) | LivaNova USA, Inc. | 2004-04-29 |
| ABBOTT ARCHITECT TOTAL PSA ASSAY (P910007/S010) | Abbott Laboratories | 2004-04-28 |
| TMX-2000 BPH THERMOTHERAPY SYSTEM (P000043/S007) | Boston Scientific Corp | 2004-04-28 |
| MENTOR INFLATABLE PENILE PROSTHESIS (P000006/S004) | Coloplast Corp. | 2004-04-28 |
| OPHTEC CAPSULAR TENSION RING MODELS 276 AND 275 AND STABILEYES MODELS STBL2US AND STBL13US (P030023) | Ophtec BV | 2004-04-27 |
| PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM (P030017) | Boston Scientific Corp | 2004-04-27 |
| MODEL 8516 PERCUTANEOUS INTRASPINAL CATHETER KIT (P860004/S058) | Medtronic, Inc. | 2004-04-26 |
| DERMAL REGENERATION TEMPLATE (P900033/S011) | Integra Lifesciences Corp. | 2004-04-23 |
| HYLAFORM (HYLAN B GEL) (P030032) | Genzyme Biosurgery | 2004-04-22 |
| TACHOS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS AND PROGRAMMER SOFTWARE VERSION A-K00.1.U/5 (P000009/S011) | Biotronik, Inc. | 2004-04-22 |
| PERCLOSE PROGLIDE 6FR SUTURE-MEDIATED CLOSURE (SMC) SYSTEM (P960043/S053) | Abbott Vascular, Inc. | 2004-04-22 |
| AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST (P940040/S003) | Roche Molecular Systems, Inc. | 2004-04-22 |
| OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014) | Biomet Manufacturing Corp | 2004-04-21 |
| RIATA DEFIBRILLATION LEAD FAMILY (P950022/S018) | ABBOTT MEDICAL | 2004-04-21 |
| DEFLUX INJECTABLE GEL (P000029/S007) | Palette Life Sciences | 2004-04-21 |
| LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE (P970015/S026) | Sofamor Danek | 2004-04-16 |
| LT-CAGE LUMBAR TAPERED FUSION DEVICE (P970015/S027) | Sofamor Danek | 2004-04-16 |
| INFUSE BONE GRAFT/LT-CAGE LUMAR TAPERED FUSION DEVICE (P000058/S008) | Medtronic Sofamor Danek USA, Inc. | 2004-04-16 |
| ALTO 2 DR MODEL 624 AND ALTO 2 VR MODEL 625 (P980049/S014) | MicroPort CRM USA, Inc. | 2004-04-15 |
| ITRELL 3, SYNERGY AND SYNGERY VERSITREL SPINAL CORD STIMULATION SYSTEMS (P840001/S072) | Medtronic Neuromodulation | 2004-04-15 |
| PROLIEVE THERMODILATATION SYSTEM (P030006/S001) | Medifocus, Inc. | 2004-04-15 |
| ZENITH FLEX AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTION SYSTEM (P020018/S003) | Cook, Inc. | 2004-04-15 |
| PROSORBA COLUMN (P850020/S017) | Fresenius Hemocare, Inc. | 2004-04-15 |
| GENESIS NEUROSTIMULATION (IPG) SYSTEM (P010032/S010) | ABBOTT MEDICAL | 2004-04-15 |
| ABBOTT AXSYM FREE PSA (P980007/S001) | Abbott Laboratories | 2004-04-15 |
| PROSORBA COLUMN (P850020/S019) | Fresenius Hemocare, Inc. | 2004-04-14 |
| 7F FREEZOR CARDIAC CYROABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM (P020045/S001) | Medtronic Cryocath, LP | 2004-04-13 |
| MEDTRONIC GEM III AT WITH APP, DEVICE MODEL 7276 AND SOFTWARE MODEL 9974 (P980050/S015) | Medtronic, Inc. | 2004-04-12 |
| ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN (P030019/S003) | Anika Therapeutics, Inc. | 2004-04-09 |
| EPIC + DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM AND THE MODEL 3307 V 4.6M SOFTWARE (P830045/S091) | St. Jude Medical, Inc. | 2004-04-09 |
| EPIC + DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P880086/S099) | ABBOTT MEDICAL | 2004-04-09 |
| EPIC+ VR MODEL V-196T AND EPIC+ DR MODEL V-239T (P910023/S072) | ABBOTT MEDICAL | 2004-04-09 |
| CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S007) | Bayer Pharma AG | 2004-04-08 |
| MEDTRONIC MODEL 7278 MAXIMO DR DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND MODEL 7232 MAXIMO VR SINGLE CHAM (P980016/S042) | Medtronic Cardiac Rhythm Disease Management | 2004-04-08 |
| ANGIO-SEAL VASCULARCLOSURE DEVICE (P930038/S038) | Terumo Medical Corporation | 2004-04-08 |
| IMAGECHECKER M5000D AND M5000DM, (SOFTWARE VERSION 5.2) (P970058/S019) | Hologic, Inc. | 2004-04-07 |
| NAVISTAR DS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER (P010068/S003) | Biosense Webster, Inc. | 2004-04-02 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR (P030024/S001) | Ortho-Clinical Diagnostics | 2004-04-02 |
| PHILOS DR-T PULSE GENERATOR AND A-K00.1.U/5 PROGRAMMER SOFTWARE (P950037/S037) | Biotronik, Inc. | 2004-03-31 |
| HER OPTION CYROABLATION THERAPY SYSTEM (P000032/S004) | CooperSurgical, Inc. | 2004-03-31 |
| ENPULSE IMPLANTABLE PULSE GENERATOR, MODELS E1DR01, E1DR03, E1DR06, E1DR21 AND MODEL 9991 V 2.0 APPLICATION SOFTWARE (P980035/S036) | Medtronic, Inc. | 2004-03-31 |
| PHILOS II DR, PHILOS II D, PHILOS II DR-T, PHILOS II SLR, PHILOS II SR, PHILOS II S, AND PROGRAMMER SOFTWARE VERSION A-U (P950037/S036) | Biotronik, Inc. | 2004-03-31 |
| PROTOS DR/CLS, PROTOS VR/CLS, AXIOS DR, AXIOS D, AXIOS S, AXIOS SR, AND AXIOS SLR PULSE GENERATORS WITH PROGRAMMER SOFT (P950037/S032) | Biotronik, Inc. | 2004-03-31 |
| INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S007) | Medtronic Sofamor Danek USA, Inc. | 2004-03-30 |
| SYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM (P860004/S060) | Medtronic, Inc. | 2004-03-29 |
| DIASORIN ETI-EBK PLUS (P990043/S006) | DiaSorin, Inc. | 2004-03-26 |
| DIASORIN ETI-AB-EBK PLUS (P990041/S005) | DiaSorin, Inc. | 2004-03-26 |
| RAY TFC AND RAY TFC UNITE (P950019/S014) | Stryker Spine | 2004-03-25 |
| CODMAN SERIES 3000 IMPLANTABLE INFUSION PUMPS (P890055/S018) | Intera Oncology | 2004-03-25 |
| AMS ACTICO N NEOSPHINCTER (P010020/S001) | Boston Scientific Corp | 2004-03-24 |
| CARDIOSEAL SEPTAL OCCULUSION SYSTEM WITH QWIK LOAD (P000049/S011) | Nmt Medical, Inc. | 2004-03-24 |
| AMS 800 URINARY CONTROL SYSTEM (P000053/S003) | Boston Scientific Corp | 2004-03-24 |
| MULTI-LINK VISION CORONARY STENT SYSTEM (P020047/S002) | Abbott Vascular | 2004-03-22 |
| (ASC)MULTI-LINK CORONARY STENT SYSTEM (P970020/S045) | Abbott Vascular, Inc. | 2004-03-22 |
| SMART CONTROL NITINOL STENT SYSTEM (P020036/S002) | Cordis US Corporation | 2004-03-19 |
| VENTAK VITALITY AVT AICD SYSTEM (MODEL A135) (P960040/S042) | Boston Scientific | 2004-03-19 |
| BELOS A+ /BELOS A+/T, /KAINOX A+ 75/15, /KAINOX A+ 75/17 (P000009/S008) | Biotronik, Inc. | 2004-03-19 |
| MENTOR SALINE-FILLED TESTICULAR PROSTHESIS (P020003/S002) | Coloplast Corp. | 2004-03-18 |
| PERCLOSE PROGLIDE 6 FRENCH SUTURE MEDIATED CLOSER (SMC) SYSTEM (P960043/S052) | Abbott Vascular, Inc. | 2004-03-18 |
| LUMBAR I/F CAGE SYSTEM (P960025/S010) | Depuy Spine, Inc. | 2004-03-17 |
| MODEL HSM65 UV ABSORBING PMMA ANTERIOR CHAMBER LENS (P880070/S010) | Abbott Medical Optics, Inc. | 2004-03-17 |
| SYNCHROMED AND SYNCHROMED II IMPLANTABLE INFUSION PUMPS (P860004/S059) | Medtronic, Inc. | 2004-03-17 |
| VIEWPOINT CK SYSTEM (P010018/S005) | Refractec, Inc. | 2004-03-16 |
| AMS SPHINCTER 800 URINARY CONTROL SYSTEM (P000053/S002) | Boston Scientific Corp | 2004-03-16 |
| ORCHESTRA PROGRAMMER (P980049/S013) | MicroPort CRM USA, Inc. | 2004-03-16 |
| GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM (P000052/S023) | Guidant Corp. | 2004-03-16 |
| ALCON REFORM CAPSULAR TENSION RING (P010059/S001) | Morcher GmbH | 2004-03-15 |
| PEPGEN P-15, PEPGEN P-15 FLOW, AND PEPGEN P-15 PUTTY (P990033/S005) | Ceramed Corp. | 2004-03-15 |
| OSTEOSPACE (P010058) | Medilink | 2004-03-15 |
| ALTO DR MODEL 614, ALTO VR MODEL 615, ALTO 2 DR MODEL 624 AND ALTO 2 VR MODEL 625 (P980049/S012) | MicroPort CRM USA, Inc. | 2004-03-15 |
| KENTROX SL ICD LEADS (P980023/S016) | Biotronik, Inc. | 2004-03-12 |
| VOYAGER OTW CORONARY DILATION CATHETER (P810046/S214) | Advanced Cardiovascular Systems, Inc. | 2004-03-12 |
| EXOGEN 2000+ AND EXOGEN 3000 (P900009/S018) | Bioventus, LLC | 2004-03-12 |
| MEDTRONIC MODEL 5076 LEAD (P930039/S018) | Medtronic, Inc. | 2004-03-10 |
| CONTAK CD 2 (MODELS H115, H119) AND APPLICATION SOFTWARE MODEL 2844 (P010012/S023) | Boston Scientific Corp | 2004-03-09 |
| VENTAK PRIZM AICD, VENTAK PRIZM HE AICE, VENTAK PRIZM 2 AICD AND VITALITY DS/EL AICD SYSTEMS (P960040/S041) | Boston Scientific | 2004-03-09 |
| MEDTRONIC ONYX SYSTEM, DEVICE MODEL 7290CX AND SOFTWARE MODEL 9999 (P980016/S040) | Medtronic Cardiac Rhythm Disease Management | 2004-03-08 |
| VITALITY 2 AICD SYSTEM (MODELS T165, T167, T175, T177), MODEL 2857 APPLICATION SOFTWARE (VERSION 2.2) AND QUICK PROFILE (P960040/S039) | Boston Scientific | 2004-03-08 |
| MEDTRONIC MODEL 2490D CARELINK MONITOR (P890003/S074) | Medtronic, Inc. | 2004-03-08 |
| SELOX SR STEROID-ELUTING ACTIVE FIXATION ENDOCARDIAL PACING LEAD MODELS SR45, SR53, SR60 SR 53,SELOX SR 60 (P950037/S034) | Biotronik, Inc. | 2004-03-08 |
| MEDTRONIC MODEL 2490D CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE FOR ENPULSE MODELS (P980035/S035) | Medtronic, Inc. | 2004-03-08 |