| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P (P000007/S004) | Edwards Lifesciences, LLC | 2004-12-29 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS MODELS 6625LP AND 6625-ESR-LP (P870077/S015) | Edwards Lifesciences, LLC | 2004-12-29 |
| CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS MODEL 2650 (P010041/S004) | Edwards Lifesciences, LLC | 2004-12-29 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROTHESIS, MODELS 2700, 2700TFX, 2800,2800TFX, 3000, 3000TFX,6900P (PERI... (P860057/S024) | Edwards Lifesciences, LLC | 2004-12-29 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S001) | W. L. Gore & Associates, Inc. | 2004-12-29 |
| CARPENTIER-EDWARDS BIOPROSTHESIS, MODELS 2625 AND 6625 AND VALVED CONDUIT MODEL 4300 (P870056/S017) | Edwards Lifesciences, LLC | 2004-12-29 |
| ORTHOVISC SODIUM HYALURONATE (P030019/S006) | Anika Therapeutics, Inc. | 2004-12-28 |
| INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S005) | Medtronic Sofamor Danek USA, Inc. | 2004-12-27 |
| SOLARGEN 2100S LASER (P970029/S009) | Cryolife, Inc. | 2004-12-23 |
| ISOMED FIXED RATE INFUSION PUMP (P990034/S005) | Medtronic, Inc. | 2004-12-23 |
| CERVICAL-STIM MODEL 505L CERVICAL FUSION SYSTEM (P030034) | Orthofix, Inc. | 2004-12-23 |
| INTERTACH (P860007/S023) | Boston Scientific | 2004-12-22 |
| CONTAK CD, CONTAK CD2, EASYTRAK, EASYTRAK 2, EASYTRAK 3, CONTAK RENEWAL, CONTAK RENEWAL 3 (P010012/S040) | Boston Scientific Corp | 2004-12-22 |
| SWEET TIP RX,SWEET PICOTIP RX,FLEXTEND (P960006/S013) | Boston Scientific | 2004-12-22 |
| VENTAK PRX, VENTAK MINI (P910077/S049) | Boston Scientific | 2004-12-22 |
| CONTAK RENEWAL TR (P030005/S006) | Guidant Corp. | 2004-12-22 |
| ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS/ADVIA CENTAUR HBC TOTAL QUALITY CONTROL MATERIALS (P040004) | Siemens Healthcare Diagnostics | 2004-12-22 |
| DELTA, VISTA (P840068/S043) | Boston Scientific | 2004-12-22 |
| ADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALS (P030056) | Siemens Healthcare Diagnostics | 2004-12-22 |
| VIGOR, DISCOVERY, MERIDIAN (P940031/S033) | Boston Scientific | 2004-12-22 |
| ENDOTAK, ENDOTAK ENDURANCE, ENDOTAK RELIANCE (P910073/S049) | Boston Scientific | 2004-12-22 |
| CYBERLITH (P800019/S012) | Boston Scientific | 2004-12-22 |
| VENTAK P2, VENTAK P3 (P930035/S014) | Boston Scientific | 2004-12-22 |
| VENTAK P (P890061/S016) | Boston Scientific | 2004-12-22 |
| RES-Q (P940008/S020) | Boston Scientific | 2004-12-22 |
| VENTAK, BIPOLAR ENDOCARDIAL (P830060/S057) | Boston Scientific | 2004-12-22 |
| COSMOS (P830026/S079) | Boston Scientific | 2004-12-22 |
| ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS (P040018) | Bayer Healthcare, LLC | 2004-12-22 |
| INSITE HER-2/NEU KIT (P040030) | Biogenex Laboratories, Inc. | 2004-12-22 |
| VENTAK AV, VENTAK VR, VENTAK PRIZM, VITALITY, VITALITY 2 (P960040/S050) | Boston Scientific | 2004-12-22 |
| RELAY (P910020/S026) | Boston Scientific | 2004-12-22 |
| SELUTE, SELUTE PICOTIP (P950001/S013) | Boston Scientific | 2004-12-22 |
| CYBERTACH (P820022/S004) | Boston Scientific | 2004-12-22 |
| FINELINE, FINELINE II (P960004/S027) | Boston Scientific | 2004-12-22 |
| KAPPA 700, KAPPA 900, ENPULSE (P980035/S040) | Medtronic, Inc. | 2004-12-20 |
| SALINED-FILLED BREAST IMPLANTS (P990074/S016) | Allergan | 2004-12-17 |
| REFLECTION CERAMIC ACETABULAR SYSTEM (P030022) | Smith & Nephew, Inc. | 2004-12-17 |
| URYX URETHRAL BULKING AGENT (P030030) | C.R. Bard, Inc. | 2004-12-16 |
| CONTAK RENEWAL 1 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (P010012/S038) | Boston Scientific Corp | 2004-12-15 |
| BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA) (P020022/S001) | Siemens Healthcare Diagnostics, Inc. | 2004-12-14 |
| DIGENE HYBRID CAPTURE HPV DNA TEST (P890064/S017) | Qiagen Gaithersburg, Inc. | 2004-12-14 |
| ABBOTT AXSYM ANTI-HCV (P970027/S003) | Abbott Laboratories | 2004-12-14 |
| STAR S4 EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM (P930016/S017) | Amo Manufacturing USA, LLC | 2004-12-14 |
| HEPATITS C CHECK TEST SYSTEM (P980046/S007) | Pwn Health Chicago, LLC | 2004-12-10 |
| ELAVIEW 1.26 UG APPLICATION SOFTWARE FOR THE ORCHESTRA PROGRAMMER; RAM PATCHES ALTO P4 AND ALTO2 P3; AND HSO 2.70 SOFTWA (P980049/S017) | MicroPort CRM USA, Inc. | 2004-12-08 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR AND THE VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIR (P000044/S005) | Ortho-Clinical Diagnostics, Inc. | 2004-12-08 |
| THINPREP 2000 SYSTEM (P950039/S013) | Hologic, Inc. | 2004-12-06 |
| GORE VIATORR TIPS (P040027) | W. L. Gore & Associates, Inc. | 2004-12-06 |
| BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS FOR OVERNIGHT WEAR FOR BAUSH & LOMB VISION SHAPING TREATMENT (P010062/S002) | Bausch & Lomb | 2004-12-03 |
| AXSYM ANTI-HCV (P970027/S002) | Abbott Laboratories | 2004-12-03 |
| EUFLEXXA (1% SODIUM HYALURONATE) (P010029) | Ferring Pharmaceuticals, Inc. | 2004-12-03 |
| GORE EXCLUDER BIFURCATED ENDOPROSTHESIS (P020004/S008) | W. L. Gore & Associates, Inc. | 2004-12-02 |
| DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S004) | Siemens Healthcare Diagnostics | 2004-12-02 |
| QUANTIFERON -TB GOLD (P010033/S006) | Qiagen | 2004-12-02 |
| EXPRESS2 STENT DELIVERY SYSTEM (P020009/S018) | Boston Scientific Scimed, Inc. | 2004-11-30 |
| TAXUS EXPRESS2 STENT DELIVERY SYSTEM (P030025/S012) | Boston Scientific Corp | 2004-11-30 |
| EASYTRAK 3 IS-1 LEAD MODELS: 4548/4549/4550 (P010012/S032) | Boston Scientific Corp | 2004-11-24 |
| MEDTRONIC INTERSTIM TINED LEAD (P970004/S030) | Medtronic Neuromodulation | 2004-11-24 |
| KODAK MAMMOGRAPHY CAD ENGINE (P030007) | Carestream Health, Inc. | 2004-11-23 |
| TAXUS EXPRESS2 CORONARY STENT SYSTEM (P030025/S008) | Boston Scientific Corp | 2004-11-22 |
| SELECTION AFM, VITATRON C60 DR, C20 SR, T60 DR, AND T20 SR PACING SYSTEMS (P990001/S016) | Medtronic, Inc. | 2004-11-22 |
| IDENTITY/IDENTITY ADX, INFINITY AND INTEGRITY FAMILIES OF PACEMAKERS (P880086/S101) | ABBOTT MEDICAL | 2004-11-22 |
| STELIX/STELIX II STEROID ELUTING PACING LEADS; EASYTURN/EASYTURN ACCESSORY SYTLET KITS (P020030/S001) | MicroPort CRM USA, Inc. | 2004-11-22 |
| CONTAK CD, CONTAK CD 2, EASYTRAK, EASYTRACK 2, EASYTRAK 3, CONTAK RENEWAL, CONTAK RENEWAL 3 (P010012/S034) | Boston Scientific Corp | 2004-11-19 |
| COSMOS (P830026/S078) | Boston Scientific | 2004-11-19 |
| SELUTE,SELUTE PICOTIP (P950001/S012) | Boston Scientific | 2004-11-19 |
| INTERTACH (P860007/S022) | Boston Scientific | 2004-11-19 |
| VENTAK AV,VENTAK VR,VENTAK PRIZM,VITALITY,VITALITY 2 (P960040/S048) | Boston Scientific | 2004-11-19 |
| ENDOTAK,ENDOTAK ENDURANCE, ENDOTAK RELIANCE (P910073/S048) | Boston Scientific | 2004-11-19 |
| DELTA, VISTA (P840068/S042) | Boston Scientific | 2004-11-19 |
| VENTAK P3 (P930035/S013) | Boston Scientific | 2004-11-19 |
| VIGOR,DISCOVERY,MERIDIAN (P940031/S032) | Boston Scientific | 2004-11-19 |
| RELAY (P910020/S025) | Boston Scientific | 2004-11-19 |
| RES-Q (P940008/S019) | Boston Scientific | 2004-11-19 |
| VENTAK BIPOLAR ENDOCARDIAL (P830060/S056) | Boston Scientific | 2004-11-19 |
| CYBERLITH (P800019/S011) | Boston Scientific | 2004-11-19 |
| SWEET TIP RX, SWEET PICOTIP RX, FLEXTEND (P960006/S012) | Boston Scientific | 2004-11-19 |
| VENTAK P (P890061/S015) | Boston Scientific | 2004-11-19 |
| VENTAK PRX, VENTAK MINI (P910077/S047) | Boston Scientific | 2004-11-19 |
| CONTACK RENEWAL TR (P030005/S004) | Guidant Corp. | 2004-11-19 |
| CYBERTACH (P820022/S003) | Boston Scientific | 2004-11-19 |
| FINELINE,FINELINE II (P960004/S026) | Boston Scientific | 2004-11-19 |
| MOSAIC PORCINE (MODEL 305) AND HANCOCK II (MODEL T505) BIOPROSTHESES (P990064/S010) | Medtronic, Inc. | 2004-11-18 |
| MOSAIC PORCINE (MODEL 305) AND HANCOCK II (MODEL T505) BIOPROSTHESES (P980043/S005) | Medtronic, Inc. | 2004-11-18 |
| THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S031) | Thoratec Laboratories Corp. | 2004-11-17 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER (P020026/S005) | Cordis Corp. | 2004-11-17 |
| MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM PULSARCI100 COCHLEAR IMPLANT (P000025/S014) | Med-El Corp. | 2004-11-17 |
| ALTO 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P980049/S016) | MicroPort CRM USA, Inc. | 2004-11-17 |
| ST. JUDE MEDICAL EPIC HF DEFIBRILLATOR MODEL V-337, ST. JUDE MEDICAL ATLAS+ HF DEFIBRILLATOR MODEL V-343 (P030054/S001) | ABBOTT MEDICAL | 2004-11-17 |
| CELSIUS DS 8MM DIAGNOSTIC/ABLATION TIP CATHETER (P010068/S005) | Biosense Webster, Inc. | 2004-11-16 |
| CAPTIQUE INJECTABLE GEL (P030032/S002) | Genzyme Biosurgery | 2004-11-12 |
| DEFLUX INJECTABLE GEL (P000029/S011) | Palette Life Sciences | 2004-11-12 |
| MEDTRONIC SYNCHROMED II IMPLANTABLE PROGRAMMABLE INFUSION PUMP SYSTEM (P860004/S063) | Medtronic, Inc. | 2004-11-12 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S011) | Boston Scientific Corp | 2004-11-11 |
| SELOX ST/JT STEROID-ELUTING PASSIVE-FIXATION ENDOCARDIAL PACKING LEAD MODELS SELOX ST 53, SELOX ST 60, SELOX JT 45 & 53 (P950037/S038) | Biotronik, Inc. | 2004-11-10 |
| GENESIS NEUROSTIMULATION SYSTEM (P010032/S012) | ABBOTT MEDICAL | 2004-11-09 |
| HER OPTION CRYOABLATION THERAPY SYSTEM (P000032/S005) | CooperSurgical, Inc. | 2004-11-09 |
| CORETHERM SYSTEM MICROWAVE THERMOTHERAPY (P010055/S002) | Prostalund AB | 2004-11-05 |
| BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS (P030031) | Biosense Webster, Inc. | 2004-11-05 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR (P030024/S002) | Ortho-Clinical Diagnostics | 2004-11-04 |