| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS MODELS 6625LP AND 6625-ESR-LP (P870077/S020) | Edwards Lifesciences, LLC | 2005-10-07 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROTHESIS, MODEL 2500P (P000007/S009) | Edwards Lifesciences, LLC | 2005-10-07 |
| CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS, MODEL 2650 (P010041/S009) | Edwards Lifesciences, LLC | 2005-10-07 |
| CARPENTIER-EDWARDS BIOPROSTHESIS, MODELS 2625 (P870056/S022) | Edwards Lifesciences, LLC | 2005-10-07 |
| ADVIA CENTAUR CP PSA ASSAY (P950021/S007) | Siemens Healthcare Diagnostics | 2005-10-07 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS, MODELS 2700, 2700TFX, 2800, 2800TFX, 3000, 3000TFX,6900, 6900P (P860057/S030) | Edwards Lifesciences, LLC | 2005-10-07 |
| ACS 180/ADVIA CENTAUR AFP IMMUNOASSAY (P930036/S003) | Siemens Healthcare Diagnostics, Inc. | 2005-10-07 |
| CARDIAC ABLATION CATHETERS (P920047/S029) | Boston Scientific Corp | 2005-10-06 |
| ABBOTT IMX HAVAB-M LIST 2263 (P790019/S020) | Abbott Laboratories | 2005-10-06 |
| BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR, MODEL 4170 (P990019/S003) | Sun Pharmaceutical Industries, Inc. | 2005-10-06 |
| TAXUS EXPRESS 2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S023) | Boston Scientific Corp | 2005-10-06 |
| ELECSYS ANTI-HBS,ELECSYS PRECICONTROL ANTI-HBS (P010054/S002) | Roche Diagnostics Corp. | 2005-10-06 |
| AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FOUR FAMILY (N17600/S023) | Davol Inc., Sub. C. R. Bard, Inc. | 2005-10-06 |
| CORDIS CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S015) | Cordis Corp. | 2005-10-06 |
| AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FAMILY (P800002/S015) | C.R. Bard, Inc. | 2005-10-06 |
| PROLIEVE THERMODILATATION SYSTEM (P030006/S007) | Medifocus, Inc. | 2005-10-06 |
| BLAZER II XP, BLAZER XP RPM CARDIAC ABLATION CATHETERS (P020025/S013) | Boston Scientific | 2005-10-06 |
| ENTRUST ICD (P980016/S052) | Medtronic Cardiac Rhythm Disease Management | 2005-09-30 |
| ENRHYTHM IPG (P980035/S045) | Medtronic, Inc. | 2005-09-30 |
| VIEWPOINT CK SYSTEM (P010018/S008) | Refractec, Inc. | 2005-09-30 |
| VNS THERAPY SYSTEM, MODEL 302 (P970003/S058) | LivaNova USA, Inc. | 2005-09-29 |
| PREPSTAIN SYSTEM (P970018/S010) | Bd Diagnostic Systems | 2005-09-28 |
| CARELINK PROGRAMMER (MODEL 2090)/ANALYZER (MODEL 2290) (P890003/S086) | Medtronic, Inc. | 2005-09-28 |
| STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM (P930016/S023) | Amo Manufacturing USA, LLC | 2005-09-28 |
| EXCLUDER BIFURCATED ENDOPROSTHESIS (P020004/S011) | W. L. Gore & Associates, Inc. | 2005-09-28 |
| THINPREP 2000 SYSTEM (P950039/S015) | Hologic, Inc. | 2005-09-28 |
| CONTAK RENEWAL TR (P030005/S018) | Guidant Corp. | 2005-09-27 |
| SONOCUR BASIC EXTRACORPOREAL SHOCK WAVE THERAPY (ESWT) (P010039/S003) | Siemens Medical Solutions USA, Inc. | 2005-09-27 |
| DISCOVERY/MERIDIAN (P940031/S043) | Boston Scientific | 2005-09-27 |
| ROTAWIRE GUIDE WIRE, A COMPONENT OF THE ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S083) | Boston Scientific Corp | 2005-09-27 |
| CONTAK RENEWAL (P010012/S073) | Boston Scientific Corp | 2005-09-27 |
| PRIZM/VITALITY (P960040/S085) | Boston Scientific | 2005-09-27 |
| STAARVISC II SODIUM HYALURONATE (P000046/S012) | Anika Therapeutics, Inc. | 2005-09-26 |
| DURASPHERE INJECTABLE BULKING AGENT (P980053/S008) | Carbon Medical Technologies, Inc. | 2005-09-26 |
| LCS TOTAL KNEE SYSTEM (P830055/S090) | Depuy, Inc. | 2005-09-26 |
| UNICOMPARTMENTAL DEVICE CONFIGURATION OF THE LCS TOTAL KNEE SYSTEM (P910016/S014) | Depuy, Inc. | 2005-09-26 |
| SYNCHROMED II IMPLANTABLE INFUSION SYSTEM (P860004/S070) | Medtronic, Inc. | 2005-09-26 |
| CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR (IOL) (P030002/S005) | Bausch & Lomb, Inc. | 2005-09-26 |
| EBI BONE HEALING SYSTEM (P790002/S023) | Ahp Eos Buyer, Inc. | 2005-09-26 |
| CONTAK RENEWAL (P010012/S072) | Boston Scientific Corp | 2005-09-23 |
| RESTORE RECHARGEABLE NEUROSTIMULATION SYSTEM (P840001/S080) | Medtronic Neuromodulation | 2005-09-23 |
| ENDOTAK RELIANCE LEADS (P910073/S054) | Boston Scientific | 2005-09-23 |
| VITALITY (P960040/S082) | Boston Scientific | 2005-09-23 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATORS (P000044/S008) | Ortho-Clinical Diagnostics, Inc. | 2005-09-22 |
| MEDTRONIC VASCULAR ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM (P990020/S021) | Medtronic Vascular | 2005-09-22 |
| VITAITY HE MODELS T180 & T182, AND VENTAK PRIZM 2 VR MODEL 1860 AICDS (P960040/S072) | Boston Scientific | 2005-09-22 |
| ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY TEST AND ELECSYS PRECICONTROL HBSAG (P990012/S002) | Roche Diagnostics Corp. | 2005-09-22 |
| HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM (P000040/S006) | Axora Medical, Inc. | 2005-09-21 |
| VITATRON T-SERIES SOFTWARE MODEL VSF07/08, VSE03/04 (P990001/S019) | Medtronic, Inc. | 2005-09-21 |
| MEDTRONIC CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR SYSTEM (P010031/S025) | Medtronic Cardiac Rhythm Disease Management | 2005-09-21 |
| HIRESOLUTION BIONIC EAR SYSTEM (P960058/S042) | Advanced Bionics | 2005-09-21 |
| CONTAK RENEWAL 3&4 FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICES (P010012/S061) | Boston Scientific Corp | 2005-09-21 |
| MEDTRONIC PACEMAKER SYSTEMS (P890003/S088) | Medtronic, Inc. | 2005-09-21 |
| MEDTRONIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS (P980016/S054) | Medtronic Cardiac Rhythm Disease Management | 2005-09-21 |
| VITALITY FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P960040/S069) | Boston Scientific | 2005-09-21 |
| WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM (P020016) | Biomet Microfixation, Inc. | 2005-09-21 |
| HER OPTION CRYOABLATION THERAPY SYSTEM (P000032/S012) | CooperSurgical, Inc. | 2005-09-21 |
| VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE (P840064/S029) | Alcon Laboratories | 2005-09-21 |
| MAMMOGRAPHY CAD ENGINE (P030007/S001) | Carestream Health, Inc. | 2005-09-16 |
| AMPLATZER DUCT OCCLUDER (P000039/S007) | ABBOTT MEDICAL | 2005-09-16 |
| AMPLATZER DUCT OCCLUDER (P020024/S002) | ABBOTT MEDICAL | 2005-09-16 |
| PRECISION SPINALCORD STIMULATION (P030017/S007) | Boston Scientific Corp | 2005-09-16 |
| MEDTRONIC ENPULSE E1/E2 IMPLANTABLE PULSE GENERATOR DEVICES (P980035/S046) | Medtronic, Inc. | 2005-09-15 |
| VENTALITY FAMILIES (P960040/S079) | Boston Scientific | 2005-09-15 |
| BIOLON 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY (P960011/S010) | Altacor , Ltd. | 2005-09-15 |
| CONTAK RENEWAL 3 (P010012/S070) | Boston Scientific Corp | 2005-09-15 |
| PRIZM 2 (P960040/S080) | Boston Scientific | 2005-09-15 |
| RENEWAL DS (P010012/S068) | Boston Scientific Corp | 2005-09-15 |
| ACRYSOF TORIC POSTERIOR CHAMBER INTRAOCULAR LENS MODELS SA60T3, SA60T4 AND SA60T5 (P930014/S015) | Alcon Laboratories, Inc. | 2005-09-14 |
| PRIZM (P960040/S076) | Boston Scientific | 2005-09-13 |
| EPIC AND ATLAS FAMILIES OF DEVICES (P950022/S026) | ABBOTT MEDICAL | 2005-09-13 |
| CONTAK RENEWAL TR (P030005/S016) | Guidant Corp. | 2005-09-13 |
| ABBOTT IMX TOTAL PSA, ABBOTT AXSYM TOTAL PSA AND ABBOTT ARCHITECT TOTAL PSA (P910007/S015) | Abbott Laboratories | 2005-09-13 |
| STARR EDWARDS SILASTIC BALL VALVE, MODELS 1260 AND 6120 (P870038/S007) | Edwards Lifesciences, LLC | 2005-09-13 |
| CONTAK RENEWAL TR MODELS H120 AND H125 (P030005/S014) | Guidant Corp. | 2005-09-13 |
| CONTAK RENEWAL/CD 2/RENEWAL RF FAMILIES (P010012/S067) | Boston Scientific Corp | 2005-09-13 |
| DISCOVERY (P940031/S042) | Boston Scientific | 2005-09-13 |
| LCS TOTAL KNEE SYSTEM (P830055/S091) | Depuy, Inc. | 2005-09-12 |
| CONTAK RENEWAL TR (P030005/S011) | Guidant Corp. | 2005-09-09 |
| CRYSTALENS SE, MODEL AT-45 SE (P030002/S004) | Bausch & Lomb, Inc. | 2005-09-08 |
| CONTAK RENEWAL TR MODELS H120 AND H125 (P030005/S015) | Guidant Corp. | 2005-09-08 |
| VENTAK PRIZM 2 DR/ VR PULSE GENERATOR (P960040/S077) | Boston Scientific | 2005-09-08 |
| LATITUDE PATIENT MANAGEMENT SYSTEM (P910077/S051) | Boston Scientific | 2005-09-08 |
| GUIDANT CONTAK RENEWAL FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY DEVICES (P010012/S062) | Boston Scientific Corp | 2005-09-07 |
| GUIDANT CONTAK RENEWAL FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY DEVICES (P010012/S065) | Boston Scientific Corp | 2005-09-07 |
| GUIDANT VITALITY FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P960040/S073) | Boston Scientific | 2005-09-07 |
| CONTAK RENEWAL TR (P030005/S012) | Guidant Corp. | 2005-09-07 |
| CONTAK RENEWAL TR IS-1 FAMILY (P030005/S013) | Guidant Corp. | 2005-09-07 |
| GUIDANT VITALITY FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P960040/S074) | Boston Scientific | 2005-09-07 |
| DISCOVERY,MERIDIAN PULSE GENERATORS (P940031/S039) | Boston Scientific | 2005-09-07 |
| DISCOVERY/MERIDIAN (P940031/S040) | Boston Scientific | 2005-09-07 |
| GUIDANT VITALITY FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND VENTAK PRIZM 2 AUTOMATIC IMPLANTABLE CARDIOVERT.. (P960040/S070) | Boston Scientific | 2005-09-07 |
| GUIDANT CONTAK RENEWAL FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY DEVICES (P010012/S064) | Boston Scientific Corp | 2005-09-07 |
| XACT CAROTID STENT SYSTEM (P040038) | Abbott Vascular, Inc. | 2005-09-06 |
| SYMPHONY/ELA RHAPSODY PACEMAKER SYSTEM AND THE ORCHESTRA PROGRAMMER (P950029/S024) | MicroPort CRM USA, Inc. | 2005-09-02 |
| 7F FREEZOR CARDIAC CRYOABLATION CATHETER & CCT.2 CRYOCONSOLE SYSTEM (P020045/S010) | Medtronic Cryocath, LP | 2005-09-02 |
| DUETT PROSEALING DEVICE (MODEL 1010), DIAGNOSTIC DUETT PRO SEALING DEVICE (MODEL 2210), AND D-STAT FLOWABLE HEMOSTAT... (P990037/S023) | Vascular Solutions, Inc. | 2005-09-02 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S044) | Terumo Medical Corporation | 2005-09-02 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S006) | W. L. Gore & Associates, Inc. | 2005-08-31 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S045) | Terumo Medical Corporation | 2005-08-31 |