| IMPLANT CONTROL SYSTEM (ICS) 3000 (P950037/S035) | Biotronik, Inc. | 2005-05-18 |
| VITALITY HE MODEL T180 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM AND THE CONSULT PROGRAMMER SOFTWARE APPLICAT (P960040/S053) | Boston Scientific | 2005-05-18 |
| RIATA DEFIBRILLATION LEADS (P950022/S019) | ABBOTT MEDICAL | 2005-05-16 |
| CERVICAL-STIM CERVICAL FUSION SYSTEM (P030034/S001) | Orthofix, Inc. | 2005-05-16 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S042) | Terumo Medical Corporation | 2005-05-16 |
| ALTO SHOCK 4 MODULES (P980049/S019) | MicroPort CRM USA, Inc. | 2005-05-13 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S043) | Terumo Medical Corporation | 2005-05-12 |
| MAVERICK 2 MONORAIL AND MAVERICK OTW PTCA CATHETERS (P860019/S201) | Scimed Life Systems, Inc. | 2005-05-11 |
| GENESIS NEUROSTIMULATION (IPG) SYSTEM (P010032/S013) | ABBOTT MEDICAL | 2005-05-11 |
| EXCLUDER BIFURCATED ENDOPROSTHESIS (P020004/S010) | W. L. Gore & Associates, Inc. | 2005-05-10 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S001) | W. L. Gore & Associates, Inc. | 2005-05-10 |
| DUAL CHAMBER IMPLANTABLE CARDIOVERTER (P030054/S009) | ABBOTT MEDICAL | 2005-05-09 |
| CADENCE (R) TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S079) | ABBOTT MEDICAL | 2005-05-09 |
| FLEXTEND LEADS, MODELS 4086, 4087, AND 4088 (P960006/S015) | Boston Scientific | 2005-05-06 |
| RIATA FAMILY OF DEFIBRILLATION LEADS (P950022/S022) | ABBOTT MEDICAL | 2005-05-05 |
| GENESIS DUAL 4-CHANNEL IMPLANTABLE PULSE GENERATOR (IPG) (P010032/S016) | ABBOTT MEDICAL | 2005-05-05 |
| RIATA FAMILY OF DEFIBRILLATION LEADS (P950022/S021) | ABBOTT MEDICAL | 2005-05-05 |
| SURGIFLO HEMOSTATIC MATRIX (P990004/S008) | Ferrosan Meidcal Devices A/S | 2005-05-05 |
| RIATA FAMILY OF DEFIBRILLATION LEADS (P950022/S020) | ABBOTT MEDICAL | 2005-05-05 |
| RIATA FAMILY OF DEFIBRILLATION LEADS (P950022/S023) | ABBOTT MEDICAL | 2005-05-05 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR (P030024/S003) | Ortho-Clinical Diagnostics | 2005-05-05 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR AND THE VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIR (P000044/S006) | Ortho-Clinical Diagnostics, Inc. | 2005-05-05 |
| ON-X PROSTHETIC HEART VALVE (P000037/S004) | On-X Life Technologies, Inc. | 2005-05-04 |
| DURALOC OPTION CERAMIC HIP SYSTEM (P040023) | DePuy Orthopaedics, Inc. | 2005-05-03 |
| DAKOCYTOMATION HER2 FISH PHARMDX KIT (P040005) | Agilent Technologies Singapore (International) Pte , Ltd. | 2005-05-03 |
| STAR S4 IR EXCIMER LASER SOFTWARE, VERSION 5.10 (P930016/S022) | Amo Manufacturing USA, LLC | 2005-05-02 |
| FRONTIER MODEL 5508L AND FRONTIER II MODEL 5586 CARDIAC RESYNCHRONIZATION THERAPY PACEMAKERS (P030035/S003) | ABBOTT MEDICAL | 2005-04-29 |
| RITHRON-XR CORONARY STENT SYSTEM (P030037) | Biotronik GmbH & Co. KG | 2005-04-29 |
| VNS THERAPY SYSTEM, MODEL 250 PROGRAMMING SOFTWARE SOFTWARE VERSION 7.0 INSTRUCTION CARD (P970003/S057) | LivaNova USA, Inc. | 2005-04-29 |
| MEDTRONIC SYNCHROMED II IMPLANTABLE INFUSION PUMP SYSTEM (P860004/S071) | Medtronic, Inc. | 2005-04-29 |
| TARGIS SYSTEM (P970008/S027) | Urologix, LLC | 2005-04-29 |
| MEDTRONIC MODEL P1501DR ENRHYTHM IMPLANTABLE PULSE GENERATOR, MEDTRONIC MODEL 9987 APPLICATION SOFTWARE AND MEDTRONIC MO (P980035/S038) | Medtronic, Inc. | 2005-04-28 |
| XELOS DR-T ICD SYSTEM AND APPLICATION SOFTWARE VERSION A-K00.3.U (P000009/S014) | Biotronik, Inc. | 2005-04-28 |
| KINETRA MODEL 7428 IMPLANTABLE NEUROSTIMULATION SYSTEM (P960009/S032) | Medtronic, Inc. | 2005-04-27 |
| ISOFLEX P LEAD FAMILY MODELS 1644T AND 1648T STEROID ELUTING, PASSIVE FIXATION ENDOCARDIAL PACING LEADS (P960030/S012) | ABBOTT MEDICAL | 2005-04-27 |
| SYMPHONY DR 2550 MODE AND ELAVIEW 1.28 UG1 PROGRAMMING SOFTWARE (P950029/S022) | MicroPort CRM USA, Inc. | 2005-04-27 |
| VOYAGER RX CORONARY DILATATION CATHETER (P810046/S219) | Advanced Cardiovascular Systems, Inc. | 2005-04-26 |
| APLIGRAF (P950032/S040) | Organogenesis, Inc. | 2005-04-25 |
| AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST (P940040/S005) | Roche Molecular Systems, Inc. | 2005-04-22 |
| AMPLICOR HCV, TEST VERSION 2.0 (P000010/S004) | Roche Molecular Systems, Inc. | 2005-04-22 |
| COBAS AMPLICOR HCV TEST, VERSION 2.0 AND COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0 (P000012/S005) | Roche Molecular Systems, Inc. | 2005-04-22 |
| HER OPTION CRYOABLATION THERAPY SYSTEM (P000032/S008) | CooperSurgical, Inc. | 2005-04-22 |
| MULTI-LINK CORONARY STENT SYSTEMS (P970020/S046) | Abbott Vascular, Inc. | 2005-04-21 |
| INFUSE BONE GRAFT (P000054/S004) | Medtronic Sofamor Danek USA, Inc. | 2005-04-20 |
| INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPAERED FUSION DEVICE (P000058/S016) | Medtronic Sofamor Danek USA, Inc. | 2005-04-20 |
| INFUSE BONE GRAFT (P000054/S005) | Medtronic Sofamor Danek USA, Inc. | 2005-04-20 |
| INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S009) | Medtronic Sofamor Danek USA, Inc. | 2005-04-20 |
| ITREL 3, SYNERGY AND SYNERGY VERSITREL IMPLANTABLE SCS SYSTEMS (P840001/S075) | Medtronic Neuromodulation | 2005-04-15 |
| VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATORS (P030026/S005) | Ortho-Clinical Diagnostics, Inc. | 2005-04-15 |
| SYNERGY PLUS+ (MODEL 7479) AND SYNERGY COMPACT+ (MODEL 7479B) NEUROSTIMULATION SYSTEMS (P840001/S077) | Medtronic Neuromodulation | 2005-04-15 |
| CORDIS CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S010) | Cordis Corp. | 2005-04-15 |
| RENEWAL PULSE GENERATORS (P010012/S046) | Boston Scientific Corp | 2005-04-14 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S031) | Cochlear Americas | 2005-04-13 |
| TECNIS FOLDABLE ACRYLIC INTRAOCULAR LENS MODEL ZA9003 (P990080/S006) | Johnson & Johnson Surgical Vision, Inc. | 2005-04-13 |
| TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S018) | Boston Scientific Corp | 2005-04-13 |
| OL1000/OL1000 SC AND SPINALOGIC BONE BROWTH STIMULATORS (P910066/S020) | Djo, LLC | 2005-04-13 |
| VERIFLEX (LIBERTE) BARE-METAL CORONARY STENT SYSTEM (P040016) | Boston Scientific Scimed, Inc. | 2005-04-12 |
| DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE (P840064/S027) | Alcon Laboratories | 2005-04-12 |
| SCULPTRA (P030050/S001) | Q-Med AB | 2005-04-11 |
| QUICKSITE 1056T LEFT VENTRICULAR PACING LEAD (P030054/S004) | ABBOTT MEDICAL | 2005-04-11 |
| RESTORE RECHARGEABLE NEUROSTIMULATION SYSTEM (P840001/S074) | Medtronic Neuromodulation | 2005-04-08 |
| CONTAK CD2, CONTAK RENEWAL/RENEWAL 3/ RENEWAL 3/3HE RF (P010012/S045) | Boston Scientific Corp | 2005-04-08 |
| DISCOVERY & MERIDIAN DEVICE (P940031/S034) | Boston Scientific | 2005-04-08 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPRSOTHESIS MODELS 6625LP AND 6625-ESR LP (P870077/S018) | Edwards Lifesciences, LLC | 2005-04-08 |
| CONTAK RENEWAL TR (P030005/S008) | Guidant Corp. | 2005-04-08 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODEL 2700, 2700TFX, 2800TFX, 3000, 3000TFX, 6900, 6900P PERIMOUN (P860057/S027) | Edwards Lifesciences, LLC | 2005-04-08 |
| VITALITY DEVICES & VENTAK PRISM DEVICES (P960040/S052) | Boston Scientific | 2005-04-08 |
| PRECISION SPINAL CORD STIMULATOR SYSTEM (P030017/S006) | Boston Scientific Corp | 2005-04-08 |
| CARBOMEDICS PROSTETIC HEART VALVE (CPHV) (P900060/S030) | Corcym S.r.l. | 2005-04-08 |
| CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS, MODEL 2650 (P010041/S007) | Edwards Lifesciences, LLC | 2005-04-08 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P (P000007/S007) | Edwards Lifesciences, LLC | 2005-04-08 |
| MEDTRONIC INSYNC III MARQUIS,MAXIMO & SENTRY (P010031/S018) | Medtronic Cardiac Rhythm Disease Management | 2005-04-08 |
| CARPENTIER-EDWARDS BIOPROSTHESIS MODELS 2625,6625, VALVED CONDUIT MODEL 4300 (P870056/S020) | Edwards Lifesciences, LLC | 2005-04-08 |
| DIABETES SENTRY (P810044/S005) | Diabetes Sentry Products, LLC | 2005-04-08 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS 2700TFX, 2800TFX, 3000TFX, AND 6900PTX (P860057/S023) | Edwards Lifesciences, LLC | 2005-04-07 |
| DURASEAL DURAL SEALANT SYSTEM (P040034) | Integra LifeSciences Corporation | 2005-04-07 |
| SYNCHROMED II PUMP (P860004/S069) | Medtronic, Inc. | 2005-04-07 |
| PRE-MOLDED HEADER CONNECTOR DESIGN FOR THE INTEGRITY DR MODEL 5336, IDENTITY DR MODEL 5370, IDENTITY ADX DR MODEL 5380, (P880086/S103) | ABBOTT MEDICAL | 2005-04-06 |
| PHYSIO-STIM MODELS 3202, 3302, 3313, 3314, 3315 AND SPINAL-STIM LODEL 2212 (P850007/S027) | Orthofix, Inc. | 2005-04-05 |
| PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY (P970054/S002) | Diasorin | 2005-04-01 |
| PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY (P970055/S002) | Diasorin | 2005-04-01 |
| ORTHOSPEC EXTRACORPOREAL SHOCK WAVE THERAPY DEVICE (P040026) | Medispec, Ltd. | 2005-04-01 |
| TAXUS EXPRESS CORONARY STENT SYSTEM (P030025/S005) | Boston Scientific Corp | 2005-03-31 |
| INTRINSIC 30 MODEL 7287 AND INTRINSIC MODEL 7288 IMPLANTABLE DEVICES (P010031/S019) | Medtronic Cardiac Rhythm Disease Management | 2005-03-31 |
| FLOSEAL MATRIX HEMOSTATIC AGENT FLOSEAL ENDOSCOPIC APPLICATOR (P990009/S016) | Baxter Healthcare Corp | 2005-03-31 |
| MEDTRONIC MODELS 2490G AND 2490J CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE (P890003/S081) | Medtronic, Inc. | 2005-03-31 |
| INSYNC MAXIMO MODEL 7303 ONYX VR (P980016/S047) | Medtronic Cardiac Rhythm Disease Management | 2005-03-31 |
| EPIC, EPIC+, AND EPIC HE ICD SYSTEMS (P030054/S006) | ABBOTT MEDICAL | 2005-03-30 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S030) | Cochlear Americas | 2005-03-30 |
| NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM (P000015/S006) | Cochlear Americas | 2005-03-30 |
| 7F FREEZOR CARDIAC CRYOABLATION CATHETER & CCT.2 CRYOCONSOLE SYSTEM (P020045/S007) | Medtronic Cryocath, LP | 2005-03-29 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HB REAGENT PACK & CALIBRATORS (P000014/S011) | Ortho-Clinical Diagnostics, Inc. | 2005-03-29 |
| BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA) (P020022/S002) | Siemens Healthcare Diagnostics, Inc. | 2005-03-25 |
| RESTYLANE INJECTABLE GEL (P040024) | Q-Med AB | 2005-03-25 |
| NOVASURE GLOBAL IMPENDENCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S012) | Hologic, Inc. | 2005-03-24 |
| COROMETRICS MODEL 146-FETAL ACOUSTIC STIMULATOR (P870025/S007) | Ge Medical Systems, Inc. | 2005-03-24 |
| ENDOTAK FAMILY INCLUDES ENDOTAK, ENDOTAK ENDURANCE, ENDOTAK RELIANCE (P910073/S050) | Boston Scientific | 2005-03-24 |
| FINELINE FAMILY INCLUDES FINELINE, FINELINE II (P960004/S028) | Boston Scientific | 2005-03-24 |
| EASYTRAK FAMILY INCLUDES EASYTRAK, EASYTRAK 2, EASYTRAK 3 (P010012/S043) | Boston Scientific Corp | 2005-03-24 |
| SELUTE FAMILY (INCLUDES SELUTE, SELUTE PICOTIP) (P950001/S014) | Boston Scientific | 2005-03-24 |