| TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S017) | Boston Scientific Corp | 2005-07-08 |
| DISCOVERY, MERIDIAN (P940031/S036) | Boston Scientific | 2005-07-08 |
| CONTRK RENEWAL (P010012/S048) | Boston Scientific Corp | 2005-07-07 |
| SIEMENS MAMMOMAT NOVATION FFDM SYSTEM (P030010/S001) | Siemens Medical Solution | 2005-07-07 |
| PROSTALUND CORETHERM SYSTEM MICROWAVE THERMOTHERAPY FOR BPH (P010055/S001) | Prostalund AB | 2005-07-07 |
| PRIZM, PRIZM 2, PRIZM HE, VITALITY, VITALITY AVT, VITALITY DS, VITALITY 2 (P960040/S056) | Boston Scientific | 2005-07-07 |
| INTRACOIL SELF-EXPANDING PERIPHERAL STENT (P000033/S002) | Medtronic Vascular, Inc. | 2005-07-07 |
| SENOGRAPHE DS & 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S020) | GE Healthcare | 2005-07-01 |
| HYLAFORM, HYLAFORM PLUS, ND CAPTIQUE (P030032/S003) | Genzyme Biosurgery | 2005-07-01 |
| PROLIEVE THERMODILATATION SYSTEM CATHETER AND HEAT EXCHANGER (P030006/S005) | Medifocus, Inc. | 2005-06-30 |
| ONCO-LIFE ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA (ONCO-LIFE) (P950042/S003) | Novadaq Technologies, Inc. | 2005-06-30 |
| HER OPTION CRYOABLATION THERAPY SYSTEM (P000032/S011) | CooperSurgical, Inc. | 2005-06-30 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL, MR AND OVER-THE-WIRE, OTW) (P030025/S020) | Boston Scientific Corp | 2005-06-29 |
| ISOFLEX S PERMANENT PACING LEAD MODELS PASSIVE PLUS DX (P960030/S011) | ABBOTT MEDICAL | 2005-06-29 |
| ELASTIC LENS SINGLE-PIECE SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS (P880091/S018) | Staar Surgical Co. | 2005-06-28 |
| C-KIT PHARMDX (P040011) | Dako North America, Inc. | 2005-06-27 |
| 7F FREEZOR CARDIAC CRYOABLATION CATHETER & CCT.2 CRYOCONSOLE SYSTEM (P020045/S009) | Medtronic Cryocath, LP | 2005-06-27 |
| 7F FREEZOR CARDIAC CRYOABLATION CATHETER & CCT.2 CRYOCONSOLE SYSTEM (P020045/S008) | Medtronic Cryocath, LP | 2005-06-24 |
| MEDTRONIC VASCULAR ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM (P990020/S019) | Medtronic Vascular | 2005-06-24 |
| OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S012) | Covidien, LLC | 2005-06-24 |
| DIASORIN ETI-HA-IGMK PLUS (P890014/S007) | DiaSorin, Inc. | 2005-06-22 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATORS (P030026/S006) | Ortho-Clinical Diagnostics, Inc. | 2005-06-22 |
| SPRINTER MX2 BALLOON DILATATION CATHETER (P790017/S083) | Medtronic, Ireland | 2005-06-22 |
| DIASORIN ETI-AB-HAVK PLUS (P890019/S011) | Diasorin | 2005-06-22 |
| DIASORIN ETI-MAK-2PLUS (P990038/S010) | DiaSorin, Inc. | 2005-06-22 |
| DIASORIN ETI-EBK PLUS (P990043/S009) | DiaSorin, Inc. | 2005-06-22 |
| PROTOS DR/CLS AND PROTOS VR/CLS (P950037/S039) | Biotronik, Inc. | 2005-06-22 |
| DIASORIN ETI-AB-EBK PLUS (P990041/S008) | DiaSorin, Inc. | 2005-06-22 |
| BELOS, CARDIAC AIRBAG, LEXOS, AND XELOS FAMILIES OF ICDS (P000009/S015) | Biotronik, Inc. | 2005-06-22 |
| DIASORIN ETI-CORE-IGMK PLUS (P990044/S007) | DiaSorin, Inc. | 2005-06-22 |
| APLIGRAF (P950032/S041) | Organogenesis, Inc. | 2005-06-20 |
| AT500 DDDRP PACING SYSTEM (MODEL AT500) AND MODEL 9968 SOFTWARE POST-MARKET (RESPECT): ADDING THE ENRHYTHM MODEL P1501DR (P980035/S041) | Medtronic, Inc. | 2005-06-20 |
| SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P030010/S002) | Siemens Medical Solution | 2005-06-20 |
| GUIDANT PULSE GENERATORS (P830060/S058) | Boston Scientific | 2005-06-20 |
| ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM (P990020/S018) | Medtronic Vascular | 2005-06-17 |
| BLAZER II/BLAZER II XP CARDIAC ABLATION CATHETERS (P020025/S011) | Boston Scientific | 2005-06-17 |
| ATLAS AND ATLAS+ IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P030054/S007) | ABBOTT MEDICAL | 2005-06-17 |
| ICD FIRMWARE VERSION 6.6.7 FOR EPIC, EPIC +, ATLAS AND ATLAS +, AND MODEL 3307 PROGRAMMER SOFTWARE VERSION 4.8.5 (P910023/S077) | ABBOTT MEDICAL | 2005-06-17 |
| BLAZER II AND BLAZER II XP CARDIAC ABLATION CATHETERS (P920047/S027) | Boston Scientific Corp | 2005-06-17 |
| CHARITE ARTIFICIAL DISC (P040006/S001) | Depuy Spine, Inc. | 2005-06-16 |
| UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH (P970008/S026) | Urologix, LLC | 2005-06-16 |
| STINGER, STINGER S, STINGER M, & STINGER SM ABLATION CATHETER (P000020/S009) | Boston Scientific Corp | 2005-06-16 |
| COOPERVISION, INC. HYDRASOFT, HYDRASOFT TORIC, HYDRASOFT XW AND HYDRASOFT TORIC XW (METHAFILCON B) SOFT (HYDROPHILIC)... (P850079/S042) | CooperVision, Inc. | 2005-06-14 |
| MEDTRONIC ENTRUST MODELS D153ATG, D153DRG, D153VRC, D154ATG, D154DRG, D154VRC, MEDTRONIC MODEL 9987 APPLICATION SOFTWAR (P980016/S046) | Medtronic Cardiac Rhythm Disease Management | 2005-06-14 |
| GORE EXCLUDER BIFURCATED ENDOPROSTHESIS (P020004/S013) | W. L. Gore & Associates, Inc. | 2005-06-14 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S005) | W. L. Gore & Associates, Inc. | 2005-06-14 |
| CONTAK RENEWAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (P010012/S047) | Boston Scientific Corp | 2005-06-14 |
| VIABAHN ENDOPROSTHESIS (P040037) | W. L. Gore & Associates, Inc. | 2005-06-14 |
| ZENITH AAA ENDOVASCULAR GRAFT (P020018/S006) | Cook, Inc. | 2005-06-14 |
| VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P960040/S055) | Boston Scientific | 2005-06-14 |
| ABBOTT IMX TOTAL PSA (P910007/S013) | Abbott Laboratories | 2005-06-13 |
| ZENITH FLEX AAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM (P020018/S005) | Cook, Inc. | 2005-06-09 |
| THINPREP IMAGING SYSTEM (P020002/S001) | Hologic, Inc. | 2005-06-08 |
| MEDTRONIC 2030A BATTERYCHECK MONITOR TO BE USED WITH THE INSYNC II MARQUIS 7289, INSYNC MARQUIS MODEL 7277, MAXIMO DR... (P980016/S051) | Medtronic Cardiac Rhythm Disease Management | 2005-06-08 |
| EDTRONIC 2030A BATTERYCHECK MONITOR (P890003/S085) | Medtronic, Inc. | 2005-06-08 |
| MEDTRONIC 2030A BATTERYCHECK MONITOR TO BE USED WITH THE INSYNC II MARQUIS 7289, INSYNC MARQUIS MODEL 7277, MAXIMO DR... (P010031/S023) | Medtronic Cardiac Rhythm Disease Management | 2005-06-08 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S022) | Boston Scientific Scimed, Inc. | 2005-06-07 |
| LIBERTE CORONARY STENT SYSTEM (P040016/S001) | Boston Scientific Scimed, Inc. | 2005-06-07 |
| TAXUS EXPRESS PACLITAXEL ELUTING CORONARY STENT SYSTEM (P030025/S019) | Boston Scientific Corp | 2005-06-07 |
| GORE EXCLUDER BIFURCATED ENDOPROSTHESIS (P020004/S012) | W. L. Gore & Associates, Inc. | 2005-06-07 |
| CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (IOL) (P030002/S003) | Bausch & Lomb, Inc. | 2005-06-06 |
| ITREL3, SYNERGY, SYNERGY VERSITREL, AND RESTORE SPINAL CORD STIMULATION SYSTEM (P840001/S076) | Medtronic Neuromodulation | 2005-06-06 |
| STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR (P990071/S005) | Biosense Webster, Inc. | 2005-06-06 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE WIRE DELIVERY (P020026/S013) | Cordis Corp. | 2005-06-06 |
| RIATA ST LEAD MODELS 7000, 7001, AND 7002 (P950022/S024) | ABBOTT MEDICAL | 2005-06-03 |
| ON-X PROSTHETIC HEART VALVE (P000037/S005) | On-X Life Technologies, Inc. | 2005-06-03 |
| EBI OSTEOGEN IMPLANTABLE GROWTH STIMULATOR AND EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR (P850035/S030) | Ahp Eos Buyer, Inc. | 2005-06-03 |
| CONSULT PROGRAMMER SOFTWARE APPLICATION MODEL 2896 VERSION 2.0 (P960040/S054) | Boston Scientific | 2005-06-03 |
| EBI OSTEOGEN IMPLANTABLE GROWTH STIMULATOR (P790005/S044) | Ahp Eos Buyer, Inc. | 2005-06-03 |
| DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S006) | Siemens Healthcare Diagnostics | 2005-06-02 |
| DIMENSION FPSA FLEX REAGENT CARTRIDGE (P020027/S003) | Siemens Healthcare Diagnostics | 2005-06-02 |
| ENTERYX PROCEDURE KIT (P020006/S008) | Boston Scientific Corp | 2005-06-02 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S011) | Cordis Corp. | 2005-05-29 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S004) | W. L. Gore & Associates, Inc. | 2005-05-27 |
| BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES-THERAPEUTIC USE (P980006/S007) | Bausch & Lomb, Inc. | 2005-05-27 |
| OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S002) | Biomet Manufacturing Corp | 2005-05-27 |
| BARD TEGRESS URETHRAL IMPLANT (P030030/S002) | C.R. Bard, Inc. | 2005-05-27 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S003) | W. L. Gore & Associates, Inc. | 2005-05-27 |
| INTERSTIM SYSTEM (P970004/S032) | Medtronic Neuromodulation | 2005-05-27 |
| BAUSCH & LOMB PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS (P980006/S008) | Bausch & Lomb, Inc. | 2005-05-27 |
| HER OPTION CRYOABLATION THERAPY SYSTEM (P000032/S009) | CooperSurgical, Inc. | 2005-05-26 |
| ADVIA CENTAUR HBSAG READY PACK REAGENTS/CONFIRMATORY READY PACK REAGENTS/QUALITY CONTROL MATERIAL (P030049) | Siemens Healthcare Diagnostics | 2005-05-26 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATORS (P000014/S012) | Ortho-Clinical Diagnostics, Inc. | 2005-05-25 |
| ABBOTT HAVAB -M EIA (P790019/S019) | Abbott Laboratories | 2005-05-25 |
| UROLOGIX PROSTATRON SYSTEM (P950014/S025) | Urologix, Inc. | 2005-05-25 |
| SENOGRAPHE DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S019) | GE Healthcare | 2005-05-25 |
| MICROSULIS MICROWAVE ENDOMETERIAL ABLATION (MEA) SYSTEM (P020031/S001) | Microsulis Medical , Ltd. | 2005-05-25 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S084) | Boston Scientific Corp | 2005-05-25 |
| DURASPHERE INJECTABLE BULKING AGENT (P980053/S009) | Carbon Medical Technologies, Inc. | 2005-05-25 |
| HOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM WITH MODEL 3180-R RECEIVER SOFTWARE (VERSION 2.1) (P910023/S078) | ABBOTT MEDICAL | 2005-05-24 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS, MODELS 2700, 2700TFX, 2800, 2800TFX, 2900, 3000, 3000TFX, 6900,X (P860057/S028) | Edwards Lifesciences, LLC | 2005-05-20 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500, 2500P (P000007/S008) | Edwards Lifesciences, LLC | 2005-05-20 |
| CHILLI II COOLED ABLATION CATHETER (P980003/S015) | Boston Scientific Corp | 2005-05-20 |
| CARPENTIER-EDWARDS SUPRANNULAR (S.A.V.) BIOPROSTHESIS, MODEL 2650,6650 (P010041/S008) | Edwards Lifesciences, LLC | 2005-05-20 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS MODELS 6625LP AND 6625-ESR-LP (P870077/S019) | Edwards Lifesciences, LLC | 2005-05-20 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S002) | W. L. Gore & Associates, Inc. | 2005-05-20 |
| CARPENTIER-EDWARDS BIOPRSOTHESIS, MODEL 2625,6625 (P870056/S021) | Edwards Lifesciences, LLC | 2005-05-20 |
| EXOGEN 2000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) AND EXOGEN 3000 SONIC ACCELERATED FRACTURE HEALING SYSTEM (P900009/S020) | Bioventus, LLC | 2005-05-19 |
| VASOSEAL ON-SITE PRECISION CLOSURE DEVICE (P920004/S020) | St. Jude Medical, Inc. | 2005-05-19 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S007) | Boston Scientific Corp | 2005-05-19 |