| VITALITY ICD (P960040/S045) | Boston Scientific | 2004-08-17 |
| CRYSTALENS MODEL AT-45 MULTIPIECE SILICONE POSTERIOR CHAMBER ACCOMMODATING INTRAOCULAR LENS (IOL) (P030002/S001) | Bausch & Lomb, Inc. | 2004-08-16 |
| FRONTIER II BIVENTRICULAR PULSE GENERATOR WITH THE MODEL 3307, V4.8M PROGRAMMER SOFTWARE (P030035/S001) | ABBOTT MEDICAL | 2004-08-16 |
| OSTEONICS ABC/TRIDENT SYSTEMS (P000013/S004) | Howmedica Osteonics Corp. | 2004-08-16 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S008) | Hologic, Inc. | 2004-08-13 |
| VENTANA MEDICAL SYSTEMS PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY (P020055) | Ventana Medical Systems, Inc. | 2004-08-11 |
| INFUSE BONE GRAFT (P000054/S002) | Medtronic Sofamor Danek USA, Inc. | 2004-08-09 |
| ORTHOVISC HIGH MOLECULAR WEIGHT HYALURON (P030019/S001) | Anika Therapeutics, Inc. | 2004-08-06 |
| EASYTRAK 2 AND EASYTRAK 2 IS-1 CORONARY VENOUS STEROID ELUTING BIPOLAR PACE/SENSE LEAD AND EASYTRAK FINISHING WIRE MODE0 (P010012/S024) | Boston Scientific Corp | 2004-08-06 |
| EASYTRAK 3 CORONARY VENOUS STERIOD ELUTING BIPOLAR PACE/SENSE LEAD (P010012/S025) | Boston Scientific Corp | 2004-08-06 |
| RESTYLANE (P020023/S009) | Q-Med AB | 2004-08-06 |
| HEALTHTRONICS OSSATRON (P990086/S004) | Sanuwave, Inc. | 2004-08-06 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S001) | Boston Scientific Corp | 2004-08-06 |
| CONTAK RENEWAL TR (P030005/S003) | Guidant Corp. | 2004-08-06 |
| CONTAK RENEWAL AND CONTAK RENEWAL 3 (P010012/S029) | Boston Scientific Corp | 2004-08-06 |
| ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS (P030040) | Siemens Healthcare Diagnostics | 2004-08-06 |
| HIRESOLUTION BIONIC EAR SYSTEM (P960058/S036) | Advanced Bionics | 2004-08-04 |
| ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (P980041/S006) | Beckman Coulter, Inc. | 2004-08-04 |
| DRIVER MX2 CORONARY STENT SYSTEM (P030009/S001) | Medtronic, Ireland | 2004-08-04 |
| LIVEWIRE TC CARDIAC ABLATION SYSTEM (P960016/S011) | St Jude Medical | 2004-08-04 |
| SCULPTRA AND SCULPTRA AESTHETIC (P030050) | Q-Med AB | 2004-08-03 |
| THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE (IVAD) (P870072/S027) | Thoratec Laboratories Corp. | 2004-08-03 |
| THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER (P870072/S028) | Thoratec Laboratories Corp. | 2004-08-03 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S009) | Hologic, Inc. | 2004-08-02 |
| HYDROGENICS 60 (OCUFILICON F) UV IMT SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR (P890023/S015) | The Cooper Companies | 2004-08-02 |
| BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENSES FOR OVERNIGHT WEAR FOR B&L VISION SHAPING TREATMENT (P010062/S001) | Bausch & Lomb | 2004-08-02 |
| ACHILLES EXPRESS ULTRASONOMETER (P970040/S003) | Ge Lunar Corp. | 2004-07-30 |
| DEFLUX INJECTABLE GEL (P000029/S009) | Palette Life Sciences | 2004-07-30 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021/S003) | Ortho-Clinical Diagnostics, Inc. | 2004-07-30 |
| AXSYM HAVAB 2.0 (P780012/S014) | Abbott Laboratories | 2004-07-30 |
| SURGIFOAM ABSORBABLE GELATIN SPONGE (P990004/S005) | Ferrosan Meidcal Devices A/S | 2004-07-29 |
| INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S002) | Medtronic Sofamor Danek USA, Inc. | 2004-07-29 |
| DIGENE HYBRID CAPTURE 2 HPV DNA TEST (P890064/S015) | Qiagen Gaithersburg, Inc. | 2004-07-29 |
| SALINE-FILLED TESTICULAR PROSTHESIS (P020003/S003) | Coloplast Corp. | 2004-07-28 |
| CURELIGHT BROADBAND (MODEL CURELIGHT 01) (P010061) | Photocure Asa | 2004-07-28 |
| KENTROX RV STEROID AND KENTROX SL STEROID IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS (P980023/S018) | Biotronik, Inc. | 2004-07-27 |
| BLAZER II XP AND BLAZER XP RPM CATHETERS (P920047/S024) | Boston Scientific Corp | 2004-07-27 |
| EPT-1000 XP CARDIAC ABLATION SYSTEM (P020025/S006) | Boston Scientific | 2004-07-27 |
| RESTYLANE (P020023/S008) | Q-Med AB | 2004-07-23 |
| HIRESOLUTION BIONIC EAR SYSTEM (P960058/S037) | Advanced Bionics | 2004-07-23 |
| UROLUME ENDOURETHRAL PROSTHESIS FOR PROSTATIC OBSTRUCTION SECONDARY TO BENIGN PROSTATIC HYPERTROPHY (P920023/S015) | Boston Scientific Corp | 2004-07-22 |
| ESSURE SYSTEM (P020014/S006) | Bayer Pharma AG | 2004-07-22 |
| WALLSTENT (TIPS AND VENOUS)ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031/S022) | Boston Scientific Corp | 2004-07-22 |
| WALLSTENT (TIPS AND VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P980033/S011) | Boston Scientific Corporation | 2004-07-22 |
| FINISHING WIRE UNIVERSAL , MODEL NUMBERS 6002,6003,6004,6005,6007 (P010012/S030) | Boston Scientific Corp | 2004-07-21 |
| WORLD HEART NOVACOR N100PC AND N100PCQ :VAS (P980012/S006) | Worldheart, Inc. | 2004-07-21 |
| MODEL 3150 PACING SYSTEM ANALYZER WAND AND THE MODEL 3307 V4.7 PROGRAMMER SOFTWARE FOR USE WITH MODEL 3510 PROGRAMMERS (P880086/S100) | ABBOTT MEDICAL | 2004-07-21 |
| INTER FIX THREADED FUSION DEVICE (P970015/S028) | Sofamor Danek | 2004-07-19 |
| 7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM (P020045/S003) | Medtronic Cryocath, LP | 2004-07-19 |
| HIRESOLUTION BIONIC EAR SYSTEM (P960058/S034) | Advanced Bionics | 2004-07-19 |
| RX CHASSIS 3 CORONARY DILATATION CATHETER (P810046/S215) | Advanced Cardiovascular Systems, Inc. | 2004-07-16 |
| AMVISC & AMVISC PLUS (P810025/S024) | Bausch & Lomb, Inc. | 2004-07-16 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATORS (P010021/S002) | Ortho-Clinical Diagnostics, Inc. | 2004-07-16 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATORS (P000014/S008) | Ortho-Clinical Diagnostics, Inc. | 2004-07-16 |
| MEDTRONIC ACTIVA PARKINSON CONTROL THERAPY (P960009/S029) | Medtronic, Inc. | 2004-07-16 |
| STAARVISC II, SHELLGEL, COEASE SODIUM HYALURONATE (P000046/S010) | Anika Therapeutics, Inc. | 2004-07-16 |
| H&LB ONE-SHOT DELIVERY SYSTEM FOR USE WITH THE ZENITH FLEX AAA ENDOVASCULAR GRAFT (P020018/S004) | Cook, Inc. | 2004-07-15 |
| PERCLOSE A-T AND PROGLIDE 6 FRENCH SUTURE MEDIATED CLOSURE (SMC) SYSTEMS (P960043/S054) | Abbott Vascular, Inc. | 2004-07-15 |
| SYMPHONY AND ELA RHAPSODY PACEMAKERS (P950029/S020) | MicroPort CRM USA, Inc. | 2004-07-15 |
| ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (P980041/S005) | Beckman Coulter, Inc. | 2004-07-15 |
| ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S008) | Boston Scientific Corp | 2004-07-15 |
| DUETT PRO SEALING DEVICE AND DIAGNOSTIC DUETT PRO SEALING DEVICE (P990037/S021) | Vascular Solutions, Inc. | 2004-07-14 |
| ORTHOVISC HIGH MODECULAR WEIGHT HYALURNAN (P030019/S005) | Anika Therapeutics, Inc. | 2004-07-14 |
| VITATRON T60 DR AND T20 SR SYSTEMS (P990001/S015) | Medtronic, Inc. | 2004-07-12 |
| DUETT PRO SEALING DEVICE MODEL 1010 (P990037/S022) | Vascular Solutions, Inc. | 2004-07-09 |
| DEFLUX INJECTABLE GEL (P000029/S008) | Palette Life Sciences | 2004-07-09 |
| INTACS PRESCRIPTION INSERTS (P980031/S008) | Addition Technology | 2004-07-08 |
| IMAGECHECKER CT CAD SOFTWARE SYSTEM (P030012) | Hologic, Inc. | 2004-07-08 |
| THORATEC HEARTMATE XVE AND VE LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P920014/S023) | Thoratec Corp | 2004-07-08 |
| VIDAS TPSA ASSAY (P040008) | bioMerieux, Inc. | 2004-07-08 |
| EPT-1000 XP CARDIAC ABLATION SYSTEM (P020025/S005) | Boston Scientific | 2004-07-07 |
| RESTYLANE (P020023/S007) | Q-Med AB | 2004-07-07 |
| LEAD ADAPTERS MODEL 6833, 6836, 6931 (P830060/S055) | Boston Scientific | 2004-07-06 |
| LEAD ADAPTERS, MODEL NUMBERS 6833, 6836, AND 6931 (P910073/S046) | Boston Scientific | 2004-07-06 |
| NIRFLEX PREMOUNTED CORONARY STENT SYSTEM (P020040/S001) | Medinol, Ltd. | 2004-07-02 |
| CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060/S029) | Corcym S.r.l. | 2004-07-02 |
| BAK VISTA INTERBODY FUSION CAGE (P950002/S014) | Zimmer Spine, Inc. | 2004-07-01 |
| LCS TOTAL KNEE SYSTEM (P830055/S088) | Depuy, Inc. | 2004-07-01 |
| QUICKSEAL SURESTAT ARTERIAL CLOSURE SYSTEM (P010049/S011) | Sub-Q, Inc. | 2004-07-01 |
| ABBOTT AXSYM ANTI-HCV (P970027/S001) | Abbott Laboratories | 2004-06-30 |
| ST JUDE MEDICAL EPIC HF SYSTEM (P030054) | ABBOTT MEDICAL | 2004-06-30 |
| ANGIOJET RHEDOLYTIC THROMBECTOMY SYSTEM CORONARY USE (P980037/S011) | Boston Scientific Corp | 2004-06-30 |
| HEARTMATE XVE LVAS (P920014/S019) | Thoratec Corp | 2004-06-29 |
| LADARVISION 4000 EXCIMER LASER SYSTEM (P970043/S015) | Alcon Laboratories | 2004-06-29 |
| CONTAK RENEWAL TR (MODEL H120 AND H125) (P030005/S002) | Guidant Corp. | 2004-06-28 |
| ABIOMED BVS5000 BI-VENTRICULAR SUPPORT SYSTEM AND AB5000 CIRCULATORY SUPPORT SYSTEM (P900023/S040) | Abiomed Cardiovascular, Inc. | 2004-06-28 |
| TRANSCYTE (P960007/S017) | Shire Regenerative Medicine | 2004-06-28 |
| ABIOMED BVS5000 BI-VENTRICULAR SUPPORT SYSTEM AND AB5000 CIRCULATORY SUPPORT SYSTEM (P900023/S041) | Abiomed Cardiovascular, Inc. | 2004-06-28 |
| SURGIFOAM ABSORBABLE GELATIN SPONGE (P990004/S006) | Ferrosan Meidcal Devices A/S | 2004-06-28 |
| PRECISION SPINAL CORD STIMULATOR SYSTEM (P030017/S001) | Boston Scientific Corp | 2004-06-28 |
| INTRINSIC 30 DUAL CHAMBER INPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (P980016/S041) | Medtronic Cardiac Rhythm Disease Management | 2004-06-25 |
| INSYNC II PROTECT MODEL 7295 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM (P010031/S014) | Medtronic Cardiac Rhythm Disease Management | 2004-06-24 |
| SPRINTER OVER-THE-WIRE (OTW) BALLOON DILATATION CATHETER (MULTIPLE MODEL NUMBERS FOR THE 1.5 MM TO 4.0 MM DIAMETERS) (P790017/S081) | Medtronic, Ireland | 2004-06-23 |
| MODEL 7303 INSYNC MAXIMO DUAL CHAMBER ICD SYSTEM AND MODEL 9998 APPLICATION SOFTWARE VERSION 1.0 FOR THE MODEL 2090 PROG (P010031/S013) | Medtronic Cardiac Rhythm Disease Management | 2004-06-23 |
| AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST (P940040/S004) | Roche Molecular Systems, Inc. | 2004-06-23 |
| STAAR SURGICAL UV-ABSORBING COLLAMER FOLDABLE INTRAOCULAR LENSES (P990013/S004) | Starr Surgical Co. | 2004-06-23 |
| GLUCOWATCH G2 BIOGRAPHER (P990026/S022) | Animas Corp. | 2004-06-22 |
| ANGIOJET PHEOLYTIC THROMBECTOMY SYSTEM (P980037/S010) | Boston Scientific Corp | 2004-06-22 |
| INSTAT COLLAGEN HEMOSTAT (P830079/S015) | ETHICON, Inc. | 2004-06-22 |
| THE BELOS, TACHOS ATX, AND LEXOS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR FAMILIES AND CARDIAC AIRBAG (P000009/S012) | Biotronik, Inc. | 2004-06-22 |