| SYNCHROMED INFUSION SYSTEM (P860004/S064) | Medtronic, Inc. | 2005-03-24 |
| PROLIEVE THERMODILATATION SYSTEM (P030006/S003) | Medifocus, Inc. | 2005-03-24 |
| SWEET TIP RX FAMILY INCLUDING SWEET TIP RX, SWEET PICOTIP RX FLEXTEND FAMILY (P960006/S014) | Boston Scientific | 2005-03-24 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043) | W. L. Gore & Associates, Inc. | 2005-03-23 |
| ABIOMED AB5000 CIRCULATORY SUPPORT SYSTEM (P900023/S042) | Abiomed Cardiovascular, Inc. | 2005-03-23 |
| SOFT ACRYLIC MULTIFOCAL ARRAY 2 (MODELS AA40E AND AA50) AND REZOOM (MODEL NXG1) INTRAOCULAR LENSES (P960028/S011) | Johnson & Johnson Surgical Vision, Inc. | 2005-03-23 |
| DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE (P840064/S026) | Alcon Laboratories | 2005-03-23 |
| VIEWPOINT CONDUCTIVE KERATOPLASTY SYSTEM (P010018/S007) | Refractec, Inc. | 2005-03-22 |
| HEARTMATE LVAS SYSTEM (P920014/S025) | Thoratec Corp | 2005-03-22 |
| THORATEC VENTRICULAR ASSIST DEVICE(VAD) SYSTEM (P870072/S033) | Thoratec Laboratories Corp. | 2005-03-22 |
| STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR (P990071/S006) | Biosense Webster, Inc. | 2005-03-21 |
| THE HEART LASER CO2 TMR SYSTEM (P950015/S010) | Laser Engineering Heart, Inc. | 2005-03-21 |
| HIGH VISCOSITY DERMABOND TOPICAL SKIN ADHESIVE (P960052/S010) | Closure Medical Corp. | 2005-03-21 |
| HER OPTION CRYOABLATION THERAPY SYSTEM (P000032/S006) | CooperSurgical, Inc. | 2005-03-21 |
| ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOL (P040020) | Alcon Research, Ltd. | 2005-03-21 |
| THINPREP 2000 SYSTEM (P950039/S014) | Hologic, Inc. | 2005-03-18 |
| STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) (P930016/S020) | Amo Manufacturing USA, LLC | 2005-03-17 |
| BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VISIBILITY TINTED CONTACT LENS (P980006/S006) | Bausch & Lomb, Inc. | 2005-03-17 |
| VITATRON C60 DR (MODEL C60A3) AND VITATRON C20 SR (MODEL C20A3) IMPLANTABLE PULSE GENERATORS AND THEIR ASSOCIATED SOFTWA (P990001/S017) | Medtronic, Inc. | 2005-03-16 |
| ULTRA2 CUTTING BALLOON MONORAIL(MR) (P950020/S012) | Boston Scientific Corp | 2005-03-16 |
| INDEPENDENCE IBOT 3000/4000 MOBILITY SYSTEM (P020033/S002) | Independence Technology, LLC | 2005-03-15 |
| PROLIEVE THERMODILATATION SYSTEM (P030006/S004) | Medifocus, Inc. | 2005-03-11 |
| RESTYLANE (P020023/S011) | Q-Med AB | 2005-03-11 |
| ABIOMED BVS5000 BI-VENTRICULAR SUPPORT SYSTEM AND AB5000 CIRCULATORY SUPPORT SYSTEM (P900023/S043) | Abiomed Cardiovascular, Inc. | 2005-03-11 |
| INFUSE BONE GRAFT (P000054/S006) | Medtronic Sofamor Danek USA, Inc. | 2005-03-11 |
| INFUSE BONE-GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S017) | Medtronic Sofamor Danek USA, Inc. | 2005-03-11 |
| MODEL 3100B HIGH-FREQUENCY OSCILLATORY VENTILATORY (HFOV) (P890057/S018) | ZOLL Medical Corporation | 2005-03-10 |
| MEDTRONIC MODEL 8516 PERCUTANEOUS INTRASPINAL CATHETER KIT (P860004/S068) | Medtronic, Inc. | 2005-03-10 |
| FLOSEAL HEMOSTATIC MATRIX (P990009/S013) | Baxter Healthcare Corp | 2005-03-10 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL, MR AND OVER-THE-WIRE, OTW) (P030025/S010) | Boston Scientific Corp | 2005-03-09 |
| EXPRESS/EXPRESS2 CORONARY STENT SYSTEM (MONORAIL, MR AND OVER-THE-WIRE, OTW) (P020009/S017) | Boston Scientific Scimed, Inc. | 2005-03-09 |
| CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW) (P950020/S011) | Boston Scientific Corp | 2005-03-08 |
| EPIC HF & ATLAS + HF CRT-D SYSTEMS (P030054/S005) | ABBOTT MEDICAL | 2005-03-08 |
| SYCHRONY PULSE GENERATOR (P880086/S102) | ABBOTT MEDICAL | 2005-03-08 |
| GUIDANT CONTAK RENEWAL TR MODELS H125 AND H120 (P030005/S005) | Guidant Corp. | 2005-03-08 |
| ADVIA CENTAUR HAV TOTAL ASSAY, ADVIA CENTAUR HAV TOTAL QUALITY CONTROL MATERIALS (P040017) | Bayer Healthcare, Diagnostics Division | 2005-03-07 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S011) | Hologic, Inc. | 2005-03-07 |
| SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM (P010038/S009) | Icad, Inc. | 2005-03-07 |
| HIRESOLUTION BIONIC EAR SYSTEM (P960058/S040) | Advanced Bionics | 2005-03-07 |
| SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P010017/S005) | Hologic, Inc. | 2005-03-07 |
| PMMA SINGLE-PIECE IOL (P840060/S029) | Alcon Laboratories | 2005-03-04 |
| GENESIS NEUROSTIMULATION SYSTEM (P010032/S014) | ABBOTT MEDICAL | 2005-03-04 |
| NC STORMER MX2/OTW BALLOON DILATATION CATHETER (P790017/S082) | Medtronic, Ireland | 2005-03-04 |
| KARL STORZ AUTOFLURESCENCE SYSTEM (P020008/S001) | KARL STORZ Endoscopy-America, Inc. | 2005-03-04 |
| PMMA VS-100 MP PC IO (P810032/S051) | Alcon Laboratories | 2005-03-04 |
| HEALON SODIUM HYALURONATE VISCELASTIC PRODUCTS, HEALON,HEALON GV, HEALON 5 (P810031/S026) | Johnson & Johnson Surgical Vision, Inc. | 2005-03-04 |
| PMMA SINGLE-PIECE ANTERIOR CHAMBER INTRAOCULAR LENSES (P880087/S011) | Alcon Laboratories | 2005-03-04 |
| HEART FAILURE PARTNER MODEL 2936 WITH SOFTWARE VERSION 1.1 (P910077/S048) | Boston Scientific | 2005-03-02 |
| SYNCHROMED INFUSION SYSTEM (P860004/S067) | Medtronic, Inc. | 2005-03-02 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S028) | Cochlear Americas | 2005-03-01 |
| EPIC AND EPIC+ DR/VR ICD SYSTEMS WITH N2 CAPACITOR (P910023/S076) | ABBOTT MEDICAL | 2005-03-01 |
| VITALITY HE MODEL T182 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM AND THE CONSULT PROGRAMMER SOFTWARE APPLICAT (P960040/S051) | Boston Scientific | 2005-03-01 |
| CHILLI II COOLED ABLATION CATHETER (P980003/S014) | Boston Scientific Corp | 2005-03-01 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPRSTHESIS, MODEL 6625LP AND 6625-ESR-LP (P870077/S017) | Edwards Lifesciences, LLC | 2005-02-28 |
| CARPENTIER-EDWARDS BIOPROSTHESIS, MODEL 2625, 6625 AND VALVED CONDUIT MODEL 4300 (P870056/S019) | Edwards Lifesciences, LLC | 2005-02-28 |
| ELA MEDICAL RATE-RESPONSIVE PACEMAKERS (P950029/S023) | MicroPort CRM USA, Inc. | 2005-02-28 |
| ELA MEDICAL IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P980049/S018) | MicroPort CRM USA, Inc. | 2005-02-28 |
| EPT-1000 XP CARDIAC ABLATION SYSTEM (P020025/S010) | Boston Scientific | 2005-02-28 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS 2700, 2700TFX 2800TFX (P860057/S026) | Edwards Lifesciences, LLC | 2005-02-28 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P (P000007/S006) | Edwards Lifesciences, LLC | 2005-02-28 |
| MED-EL COMBI 40+/PULSAR COCHLEAR IMPLANT SYSTEM (P000025/S018) | Med-El Corp. | 2005-02-28 |
| BLAZER II AND BLAZER II XP CARDIAC ABLATION CATHETERS (P920047/S026) | Boston Scientific Corp | 2005-02-28 |
| CARPENTIER-SUPRAANNULAR (S.A.V.) BIOPROSTHESIS MODEL 2650 (P010041/S006) | Edwards Lifesciences, LLC | 2005-02-28 |
| OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S011) | Covidien, LLC | 2005-02-25 |
| MODEL 3100B HIGH FREQUENCY OSCILLATORY VENTILATOR (P890057/S017) | ZOLL Medical Corporation | 2005-02-25 |
| PROSTATRON (P950014/S024) | Urologix, Inc. | 2005-02-23 |
| SYNCHROMED II INFUSION SYSTEM (P860004/S065) | Medtronic, Inc. | 2005-02-22 |
| PROSTATRON (P950014/S023) | Urologix, Inc. | 2005-02-18 |
| STAR S4 EXCIMER LASER AND WAVESCAN WAVEFRONT SYSTEMS (P930016/S019) | Amo Manufacturing USA, LLC | 2005-02-18 |
| PROGRAMMER SOFTWARE APPLICATION MODEL 2812 VERSION 1.3 (P960040/S049) | Boston Scientific | 2005-02-18 |
| UROLOGIX TARGIS SYSTEM (P970008/S024) | Urologix, LLC | 2005-02-18 |
| SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P010025/S005) | Hologic, Inc. | 2005-02-18 |
| MEDTRONIC MODEL 2090 CARELINK PROGRAMMER WITH TELEMETRY C (P890003/S080) | Medtronic, Inc. | 2005-02-18 |
| IMAGECHECKER M5000, IMAGECHECKER M5000 DM, IMAGECHECKER M5000LX, IMAGECHECKER M5000 M5000 DX VERSION 8.0 (P970058/S020) | Hologic, Inc. | 2005-02-17 |
| ENDOLOGIX POWERLINK SYSTEM (P040002/S001) | Endologix, LLC | 2005-02-15 |
| CARELINK MONITOR MODELS 2490G, 2490H AND 2490J (P890003/S079) | Medtronic, Inc. | 2005-02-15 |
| EXPRESS, EXPRESS2 CORONARY STENT SYSTEM (MOMORAIL AND OVER-THE-WIRE) (P020009/S019) | Boston Scientific Scimed, Inc. | 2005-02-15 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) (P030025/S014) | Boston Scientific Corp | 2005-02-15 |
| ALLEGRETTO WAVE EXCIMER LASER SYSTEM (P020050/S002) | Alcon Laboratories, Inc. | 2005-02-15 |
| PTCA BALLOON CATHETERS, EXPRESS2 CORONARY STENT SYSTEM AND TAXUS EXPRESS2 (P860019/S202) | Scimed Life Systems, Inc. | 2005-02-15 |
| ALLEGRETTO WAVE EXCIMER LASER SYSTEMS (P030008/S002) | Alcon Laboratories, Inc. | 2005-02-15 |
| LIFEVEST (WCD 300) DEVICE WITH APPLICATION SOFTWARE VERSION 4.0 (P010030/S006) | Zoll Manufacturing Corporation | 2005-02-15 |
| UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH (P970008/S025) | Urologix, LLC | 2005-02-15 |
| PTCA BALLOON CATHETERS, EXPRESS2 CORONARY STENT SYSTEM AND TAXUS EXPRESS2 (P030025/S015) | Boston Scientific Corp | 2005-02-15 |
| PTCA BALLOON CATHETERS, EXPRESS2 CORONARY STENT SYSTEM AND TAXUS EXPRESS2 (P020009/S020) | Boston Scientific Scimed, Inc. | 2005-02-15 |
| SJM MASTERS SERIES AORTIC VALVED PROSTHESIS WITH VASCUTEK GELWEAVE VALSALVA GRAFT (MODEL VAVGJ-515) (P810002/S058) | ABBOTT MEDICAL | 2005-02-14 |
| SYNCHROMED IMPLANTABLE INFUSION SYSTEM FOR THE INTRATHECAL ADMINISTRATION OF PRIALT (ZICONOTIDE) (P860004/S066) | Medtronic, Inc. | 2005-02-14 |
| DIMENSION FPSA FLEX REAGENT CARTRIDGE (P020027/S002) | Siemens Healthcare Diagnostics | 2005-02-11 |
| PREPSTAIN SYSTEM (P970018/S009) | Bd Diagnostic Systems | 2005-02-11 |
| CONTAK RENEWAL 3, MODELS H170, H175, H177 AND H179 (P010012/S041) | Boston Scientific Corp | 2005-02-11 |
| DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S005) | Siemens Healthcare Diagnostics | 2005-02-11 |
| VITROS IMMUNODIAGNOSTIC ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021/S005) | Ortho-Clinical Diagnostics, Inc. | 2005-02-11 |
| MODEL 3120 ZOOM LATITUDE PROGRAMMING SYSTEM (P910077/S046) | Boston Scientific | 2005-02-10 |
| TEGRESS URETHRAL IMPLANT (P030030/S001) | C.R. Bard, Inc. | 2005-02-09 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S082) | Boston Scientific Corp | 2005-02-09 |
| CONTAK RENEWAL 3 RF/HE CRT-D,CONSULT PROGRAMMER SOFT WARE (P010012/S031) | Boston Scientific Corp | 2005-02-09 |
| INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPARED FUSION DEVICE (P000058/S015) | Medtronic Sofamor Danek USA, Inc. | 2005-02-04 |
| SENSAR SOFT ACRYLIC UV LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) (P980040/S006) | Johnson & Johnson Surgical Vision, Inc. | 2005-02-04 |
| CEEON PMMA UV-LIGHT ABSORBING POSTERIOR CHAMBER (IOLS) (P810055/S071) | Advanced Medical Optics, Inc. | 2005-02-04 |
| CEEON EDGE AND TECNIS FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (P990080/S005) | Johnson & Johnson Surgical Vision, Inc. | 2005-02-04 |