| RELIANCE LEADS (P910073/S053) | Boston Scientific | 2005-08-31 |
| FLEXTEND LEADS (P960006/S017) | Boston Scientific | 2005-08-31 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S022) | Boston Scientific Corp | 2005-08-31 |
| STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM (P930016/S021) | Amo Manufacturing USA, LLC | 2005-08-30 |
| ETI-AB-COREK PLUS (P990045/S008) | DiaSorin, Inc. | 2005-08-29 |
| PROSORBA COLUMN (P850020/S021) | Fresenius Hemocare, Inc. | 2005-08-25 |
| AFFINITY, IDENTITY, INTEGRITY, AND FRONTIER FAMILY OF DEVICES (P880086/S105) | ABBOTT MEDICAL | 2005-08-25 |
| ON-X PROSTHETIC HEART VALVE (P000037/S007) | On-X Life Technologies, Inc. | 2005-08-25 |
| CONTAK RENEWAL (P010012/S059) | Boston Scientific Corp | 2005-08-25 |
| AFFINITY, IDENTITY, INTEGRITY, AND FRONTIER FAMILY OF DEVICES (P880086/S106) | ABBOTT MEDICAL | 2005-08-25 |
| GUARDIAN RT (P980022/S012) | Medtronic Minimed | 2005-08-24 |
| INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S014) | Medtronic Sofamor Danek USA, Inc. | 2005-08-22 |
| INFUSE BONE GRAFT (P000054/S003) | Medtronic Sofamor Danek USA, Inc. | 2005-08-22 |
| RAMWARE (BASELINE 15 WITH INC5 RAMWARE) UPDATE TO THE MEDTRONIC ENTRUST 30J/35J ICD SYSTEMS (P980016/S053) | Medtronic Cardiac Rhythm Disease Management | 2005-08-19 |
| UVAR XTS PHOTOPHERESIS SYSTEM (P860003/S043) | Therakos Development Limited | 2005-08-19 |
| PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S008) | Boston Scientific Corp | 2005-08-18 |
| PROSORBA PROTEIN A IMMUNOADSORPTION COLUMN (P850020/S020) | Fresenius Hemocare, Inc. | 2005-08-17 |
| MATRIX VASCULAR CLOSURE SYSTEM (VSG) (P040044) | Cordis US Corporation | 2005-08-17 |
| CONTAK RENEWAL, CONTAK RENEWAL 3, CONTAK RENEWAL 3 HE, CONTAK RENEWAL E RF, CONTAK RENEWAL 3 RF HE W/CONSULT PROG SFTWR (P010012/S056) | Boston Scientific Corp | 2005-08-16 |
| CONTAK RENEWAL 3 RF CRT-D SYSTEM (P010012/S044) | Boston Scientific Corp | 2005-08-15 |
| MODEL 3120 ZOOM LATITUDE PROGRAMMER/ RECORDER/MONITOR, MODEL 3122 ANTENNA ACCESSORY, AND CONSULT PROGRAMMER SOFTWARE... (P910077/S050) | Boston Scientific | 2005-08-15 |
| INSYNC REGISTRY (P010015/S013) | Medtronic, Inc. | 2005-08-12 |
| PERCLOSE PROGLIDE 6 FRENCH SUTURE-MEDIATED CLOSURE (SMC) SYSTEM (P960043/S057) | Abbott Vascular, Inc. | 2005-08-11 |
| LUMOS VR-T AND LUMOS DR-T IMPLANTABLE CARDIOVERTER DEFIBRILLATORS WITH 502.U ICS PROGRAMMER SOFTWARE, A-K00.4.U EPR/... (P000009/S016) | Biotronik, Inc. | 2005-08-11 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021/S006) | Ortho-Clinical Diagnostics, Inc. | 2005-08-11 |
| ORBASONE PAIN RELIEF SYSTEM (P040039) | Orthometrix, Inc. | 2005-08-10 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR/CONFIRMATORY KIT (P000044/S007) | Ortho-Clinical Diagnostics, Inc. | 2005-08-08 |
| SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE (P040021) | ABBOTT MEDICAL | 2005-08-05 |
| THINPREP 2000 SYSTEM (P950039/S012) | Hologic, Inc. | 2005-08-05 |
| AMO SILICONE MONOFOCAL AND MULTIFOCAL INTRAOCULAR LENS (P880081/S031) | Johnson & Johnson Surgical Vision, Inc. | 2005-08-04 |
| CONTAK RENEWAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), MODELS H135, H170, H175, H177, AND H179 (P010012/S054) | Boston Scientific Corp | 2005-08-04 |
| AMO SILICONE MONOFOCAL AND MULTIFOCAL INTRAOCULAR LENS (P960028/S014) | Johnson & Johnson Surgical Vision, Inc. | 2005-08-04 |
| MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM FOREMAN NEEDLE (P970004/S029) | Medtronic Neuromodulation | 2005-08-04 |
| FLEXTEND FAMILY OF PACING LEADS (P960006/S016) | Boston Scientific | 2005-08-04 |
| RELIANCE ACTIVE FIX AND PASSIVE FIX STEROID ELUTING ENDOCARDIAL DEFIBRILLATION LEAD (P910073/S052) | Boston Scientific | 2005-08-03 |
| SHELLGEL SODIUM HYALURONATE (P000046/S011) | Anika Therapeutics, Inc. | 2005-08-03 |
| MEDTRONIC SELECTSECURE LEAD MODEL 3830 (P030036) | Medtronic Cardiac Rhythm Disease Management | 2005-08-03 |
| DEFLUX INJECTABLE GEL (P000029/S012) | Palette Life Sciences | 2005-08-02 |
| PROVISC OPHTHALMIC VISCOSURGICAL DEVICE, PROVISC PACKAGED IN DUOVISC VISCOELASTIC SYSTEM AND DISCOVISC OPHTHALMIC VISCO (P840064/S028) | Alcon Laboratories | 2005-07-29 |
| CONTAK RENEWAL 3 MODELS H170, H173 & H175 AND CONTAK RENEWAL 3 HE MODELS H177 & H179 (P010012/S055) | Boston Scientific Corp | 2005-07-29 |
| VENTAK PRIZM 2 DR AICD MODEL 1861 (P960040/S066) | Boston Scientific | 2005-07-29 |
| PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (P890047/S017) | Alcon Research, Ltd. | 2005-07-29 |
| ACRYSOF RESTOR NATURAL IOL MODELS SN60D3 AND MN60D3 (P040020/S001) | Alcon Research, Ltd. | 2005-07-29 |
| PRIZM, PRIZM HE, PRIZM 2, VITALITY, VITALITY AVT, VITALITY DS, VITALITY EL (P960040/S064) | Boston Scientific | 2005-07-27 |
| MERIDIAN/DISCOVERY (P940031/S037) | Boston Scientific | 2005-07-27 |
| CONTAK CD 2, CONTAK RENEWAL 3 DS, CONTAK RENEWAL 3 HE (P010012/S053) | Boston Scientific Corp | 2005-07-27 |
| INTER FIX TM THREADED FUSION DEVICE (P970015/S031) | Sofamor Danek | 2005-07-27 |
| SALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS (P990075/S016) | Mentor Worldwide, LLC | 2005-07-27 |
| CONTAK RENEWAL FAMILY (P010012/S057) | Boston Scientific Corp | 2005-07-27 |
| VITALITY HE MODELS T180 AND T182 (P960040/S067) | Boston Scientific | 2005-07-27 |
| KAPPA 700/650/600, KAPPA 900/800 AND ENPULSE E1/E2 (P980035/S044) | Medtronic, Inc. | 2005-07-26 |
| MEDTRONIC 2020A CARDIOSIGHT READER AND THE MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) SOFTWARE (P010031/S020) | Medtronic Cardiac Rhythm Disease Management | 2005-07-26 |
| 2020A CARDIOSIGHT READER AND MODEL 2491 DEVICE DATA MANAGEMENT (P890003/S082) | Medtronic, Inc. | 2005-07-26 |
| MEDTRONIC 2020A CARDIOSIGHT READER AND THE MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) SOFTWARE (P980016/S048) | Medtronic Cardiac Rhythm Disease Management | 2005-07-26 |
| COMBI 40+ SYSTEM WITH C40+ OR PULSARCI100 COCHLEAR IMPLANTS (P000025/S019) | Med-El Corp. | 2005-07-25 |
| HIRESOLUTION BIONIC EAR SYSTEM (P960058/S045) | Advanced Bionics | 2005-07-25 |
| INSTAT COLLAGEN HEMOSTAT (P830079/S016) | ETHICON, Inc. | 2005-07-22 |
| LT-CAGE LUMBAR TAPERED FUSION DEVICE (P970015/S029) | Sofamor Danek | 2005-07-22 |
| INTERCEED (TC7) ABSORBABLE ADHESION BARRIER (P880047/S009) | ETHICON, Inc. | 2005-07-22 |
| SURGICEL / SURGICEL NU-KNIT / SURGICEL FIBRILLAR ABSORBABLE HEMOSTAT (N12159/S020) | ETHICON, Inc. | 2005-07-22 |
| CONTAK CD FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (P960040/S062) | Boston Scientific | 2005-07-22 |
| PROLIEVE THERMODILATATION SYSTEM (P030006/S006) | Medifocus, Inc. | 2005-07-22 |
| VENTAK FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P010012/S051) | Boston Scientific Corp | 2005-07-22 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S014) | Hologic, Inc. | 2005-07-22 |
| PRIZM, PRIZM 2, VITALITY, VITALITY 2 & VITALITY AVT (P960040/S061) | Boston Scientific | 2005-07-21 |
| CONTAK CD CRT-D MODELS H115, H119 AND CONTAK RENEWAL CRT-D MODELS H120, H125 (P010012/S049) | Boston Scientific Corp | 2005-07-21 |
| VITALITY AVT ICDS MODELS A135, A155 (P030005/S009) | Guidant Corp. | 2005-07-21 |
| VIGOR,DISCOVERY,AND MERIDIAN PACEMAKERS (P940031/S035) | Boston Scientific | 2005-07-21 |
| VITALITY ICD MODELS T125, T127, T135 AND VITALITY AVT ICD MODEL A155 (P960040/S058) | Boston Scientific | 2005-07-21 |
| ONYX LIQUID EMBOLIC SYSTEM (P030004) | Ev3 Neurovascular | 2005-07-21 |
| CONTAK RENEWAL & CONTAK RENEWAL 3 RF (P010012/S050) | Boston Scientific Corp | 2005-07-21 |
| PRIZM ICS MODELS 1850, 1851, 18521853 (P960040/S059) | Boston Scientific | 2005-07-21 |
| STARR-EDWARDS SILASTIC BALL PROSTHESIS,MODELS 1260 & 6120 (P870038/S005) | Edwards Lifesciences, LLC | 2005-07-20 |
| MEDTRONIC SYNCHROMED II IMPLANTABLE PROGRAMMABLE INFUSION PUMP (P860004/S072) | Medtronic, Inc. | 2005-07-19 |
| HYALGAN (P950027/S006) | Fidia Farmaceutici S.P.A. | 2005-07-19 |
| SYNCHROMED II IMPLANTABLE PROGRAMMABLE INFUSION PUMP (P860004/S073) | Medtronic, Inc. | 2005-07-19 |
| SPINALOGIC 1000 BONE GROWTH STIMULATOR (P910066/S021) | Djo, LLC | 2005-07-19 |
| MEDTRONIC INSYNC MAXIMO MODEL 7304 AND MODEL 7303 (P010031/S024) | Medtronic Cardiac Rhythm Disease Management | 2005-07-18 |
| MEDTRONIC MODEL 2490G CARELINK MONITOR AND MODEL 2491 DDMA SOFTWARE (P890003/S087) | Medtronic, Inc. | 2005-07-18 |
| KENTROX FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEADS, RV, SL, RV-S, SLS (P980023/S019) | Biotronik, Inc. | 2005-07-18 |
| GUARDIAN RT CONTINUOUS GLUCOSE MONITORING SYSTEM (P980022/S011) | Medtronic Minimed | 2005-07-18 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATORS (P030026/S007) | Ortho-Clinical Diagnostics, Inc. | 2005-07-18 |
| FLEXTOME CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW) (P950020/S010) | Boston Scientific Corp | 2005-07-18 |
| VNS THERAPY SYSTEM (P970003/S050) | LivaNova USA, Inc. | 2005-07-15 |
| HIRESOLUTION BIONIC EAR SYSTEM (P960058/S046) | Advanced Bionics | 2005-07-14 |
| HERCEP TEST (P980018/S004) | Agilent Technologies Singapore (International) Pte , Ltd. | 2005-07-13 |
| DIMENSION FPSA FLEX REAGENT CARTRIDGE (P020027/S004) | Siemens Healthcare Diagnostics | 2005-07-13 |
| STOCKERT 70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION (P990071/S007) | Biosense Webster, Inc. | 2005-07-12 |
| RESTYLANE INJECTION GEL (P040024/S001) | Q-Med AB | 2005-07-12 |
| ESSURE SYSTEM (P020014/S009) | Bayer Pharma AG | 2005-07-12 |
| HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM (P000040/S005) | Axora Medical, Inc. | 2005-07-12 |
| DISCOVERY/MERIDIAN (P940031/S038) | Boston Scientific | 2005-07-11 |
| DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S008) | Siemens Healthcare Diagnostics | 2005-07-11 |
| ON-X PROSTHETIC HEART VALVE (P000037/S006) | On-X Life Technologies, Inc. | 2005-07-11 |
| PULSE GENERATOR (P880086/S104) | ABBOTT MEDICAL | 2005-07-08 |
| CONTAK RENEWAL TR (P030005/S010) | Guidant Corp. | 2005-07-08 |
| VENTAK MINI (P910077/S052) | Boston Scientific | 2005-07-08 |
| RELIANCE TRANSVENOUS ENDOCARDIAL DEFIBRILLATION LEAD (P910073/S051) | Boston Scientific | 2005-07-08 |
| CONTAK CD, CONTAK RENEWAL, EASYTRAK (P010012/S052) | Boston Scientific Corp | 2005-07-08 |
| PRIZM, VENTAK AV, VENTAK VR, VITALITY (P960040/S063) | Boston Scientific | 2005-07-08 |