| ANGIOJET RHEOLYTIC THROMBECTOMY CATHETER SYSTEM (P980037/S009) | Boston Scientific Corp | 2004-06-22 |
| AFFINITY ANTERIOR CERVICAL CAGE SYSTEM (P000028/S005) | Medtronic Sofamor Danek USA, Inc. | 2004-06-18 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S081) | Boston Scientific Corp | 2004-06-18 |
| VOYAGER RX CORONARY DILATATION CATHETER (P810046/S216) | Advanced Cardiovascular Systems, Inc. | 2004-06-18 |
| STELID II/STELIX/STELIX II ENDOCARDIAL PACING LEAD (P020030) | MicroPort CRM USA, Inc. | 2004-06-17 |
| DEVICE: ABBOTT AXSYM HAVAB-M 2.0 (P790019/S018) | Abbott Laboratories | 2004-06-16 |
| ITREL 3 SYNERGY AND SYNERGY VERITREL SPINAL CORD STIMULATION SYSTEMS (P840001/S073) | Medtronic Neuromodulation | 2004-06-16 |
| APLIGRAF (P950032/S038) | Organogenesis, Inc. | 2004-06-14 |
| SILICONE AND PMMA INTRAOCULAR LENSES AND OCUCOAT (P840039/S053) | Bausch & Lomb, Inc. | 2004-06-14 |
| SILICONE AND PMMA INTRAOCULAR LENSES AND OCUCOAT (P910061/S011) | Bausch & Lomb | 2004-06-14 |
| SILICONE AND PMMA INTRAOCULAR LENSES AND OCUCOAT (P880090/S020) | Bausch & Lomb, Inc. | 2004-06-14 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S008) | Cordis Corp. | 2004-06-14 |
| SILICONE AND PMMA INTRAOCULAR LENSES AND OCUCOAT (P860047/S016) | Bausch & Lomb, Inc. | 2004-06-14 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR (P030026/S001) | Ortho-Clinical Diagnostics, Inc. | 2004-06-14 |
| INFUSE BONE GRAFT (P000054/S001) | Medtronic Sofamor Danek USA, Inc. | 2004-06-10 |
| NOVOSTE BETA-CATH 3.5F SYSTEM (P000018/S040) | Best Vascular, Inc. | 2004-06-10 |
| GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM (P000052/S025) | Guidant Corp. | 2004-06-10 |
| INFUSE BONE GRAFT-LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S010) | Medtronic Sofamor Danek USA, Inc. | 2004-06-10 |
| 7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM (P020045/S005) | Medtronic Cryocath, LP | 2004-06-10 |
| PROSTATRON PRAKTIS (P950014/S022) | Urologix, Inc. | 2004-06-10 |
| MAVERICK MONORAIL PTCA CATHETER SYSTEM AND MAVERICK2 MONORAIL PTCA CATHETER SYSTEM (P860019/S200) | Scimed Life Systems, Inc. | 2004-06-10 |
| ESSURE SYSTEM (P020014/S005) | Bayer Pharma AG | 2004-06-10 |
| EPT-1000 XP CARDIAC ABLATION SYSTEM (P020025/S004) | Boston Scientific | 2004-06-09 |
| CAPUSRE SP/SENSE SP NOVUS (P830061/S037) | Medtronic Cardiac Rhythm Disease Management | 2004-06-08 |
| CAPSURE SP NOVUS Z NOVUS (P850089/S053) | Medtronic Cardiac Rhythm Disease Management | 2004-06-08 |
| MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION SYSTEM (P970004/S025) | Medtronic Neuromodulation | 2004-06-08 |
| MODEL 6948 AND 6930 LEADS (P920015/S030) | Medtronic, Inc. | 2004-06-08 |
| MEDTRONIC CAPSUREFIX NOVUS (P930039/S019) | Medtronic, Inc. | 2004-06-08 |
| INTRASTENT DOUBLESTRUT STENT (P030045) | Medtronic Vascular, Inc. | 2004-06-08 |
| MODEL 6949 AND 6931 LEADS (P920015/S029) | Medtronic, Inc. | 2004-06-08 |
| SENOGRAPHE 2100D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S017) | GE Healthcare | 2004-06-07 |
| AT500 DDDRP PACING SYSTEM (P980035/S037) | Medtronic, Inc. | 2004-06-07 |
| EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENS FOR OVERNIGHT WEAR (P010062) | Bausch & Lomb | 2004-06-07 |
| STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM AND WAVESCAN WAVEFRONT SYSTEM (P930016/S018) | Amo Manufacturing USA, LLC | 2004-06-07 |
| NEUGRAFT (P900039/S013) | Neucoll, Inc. | 2004-06-07 |
| AMVISC TM & AMVISC TM PLUS (P810025/S023) | Bausch & Lomb, Inc. | 2004-06-04 |
| WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM (P030008/S001) | Alcon Laboratories, Inc. | 2004-06-04 |
| STAARVISC II,SHELLGEL AND COEASE (P000046/S009) | Anika Therapeutics, Inc. | 2004-06-04 |
| WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM (P020050/S001) | Alcon Laboratories, Inc. | 2004-06-04 |
| ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN (P030019/S004) | Anika Therapeutics, Inc. | 2004-06-04 |
| SYNCHROMED IMPLANTABLE INFUSION SYSTEM (P860004/S061) | Medtronic, Inc. | 2004-06-04 |
| EXCLUDER BIFURCATED ENDOPROTHESIS (P020004/S006) | W. L. Gore & Associates, Inc. | 2004-06-02 |
| BIOCURVE SOFT CONTACT LENSES (P860040/S016) | Wavetouch Technologies, LLC | 2004-05-28 |
| NIDEK EC-5000 EXCIMER LASER SYSTEM (P970053/S008) | Nidek Co., Ltd. | 2004-05-28 |
| MEDTRONIC INSYNC ICD MODEL 7272 AND MODEL 9969 APPLICATION SOFTWARE (P010031/S012) | Medtronic Cardiac Rhythm Disease Management | 2004-05-28 |
| PREPSTAIN SYSTEM (P970018/S007) | Bd Diagnostic Systems | 2004-05-28 |
| OCUCOAT, PMMA AND SILICONE INTRAOCULAR LENSES (P860047/S018) | Bausch & Lomb, Inc. | 2004-05-27 |
| SUPARTZ (P980044/S001) | Seikagaku Corp. | 2004-05-27 |
| OCUCOAT, PMMA AND SILICONE INTRAOCULAR LENSES (P840039/S054) | Bausch & Lomb, Inc. | 2004-05-27 |
| OCUCOAT, PMMA AND SILICONE INTRAOCULAR LENSES (P910061/S012) | Bausch & Lomb | 2004-05-27 |
| MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL, LEAD MODELS 3080, 3886, 3889, 3092, 3093, 3966, AND 3095 (P970004/S028) | Medtronic Neuromodulation | 2004-05-27 |
| OCUCOAT, PMMA AND SILICONE INTRAOCULAR LENSES (P880090/S021) | Bausch & Lomb, Inc. | 2004-05-27 |
| CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE (P990023/S003) | Alcon Laboratories | 2004-05-26 |
| LEA'S SHIELD BARRIER CONTRACEPTIVE (P010043/S001) | Yama, Inc. | 2004-05-26 |
| ENTERYX PROCEDURE KIT (P020006/S004) | Boston Scientific Corp | 2004-05-26 |
| ST AIA-PACK PA (P910065/S005) | Tosoh Bioscience, Inc. | 2004-05-25 |
| QUICKSEAL SURESHOT ARTERIAL CLOSURE SYSTEM (P010049/S010) | Sub-Q, Inc. | 2004-05-25 |
| ICAD SYSTEM (P010038/S006) | Icad, Inc. | 2004-05-21 |
| CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD (P000049/S014) | Nmt Medical, Inc. | 2004-05-21 |
| DIASORIN ETI-MAK-2 PLUS (P990038/S008) | DiaSorin, Inc. | 2004-05-19 |
| ICAD SYSTEM (P010038/S007) | Icad, Inc. | 2004-05-19 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM WITH NUCLEUS 24 CONTOUR ADVANCE/SOFTIP II ELECTRODE AND INSERTION TOOL (P970051/S027) | Cochlear Americas | 2004-05-18 |
| BLAZER RPM CARDIAC ABLATION CATHETERS (P920047/S023) | Boston Scientific Corp | 2004-05-18 |
| VENTAK AV, VENTAK VR, VENTAK PRIZMALITY, VITALITY 2 (P960040/S044) | Boston Scientific | 2004-05-14 |
| CONTAK CD, CONTAK CD 2, EASYTRAK, CONTAK RENEWAL, CONTAK RENEWAL 3 (P010012/S027) | Boston Scientific Corp | 2004-05-14 |
| EXPRESS 2 CORONARY STENT SYSTEM (P020009/S016) | Boston Scientific Scimed, Inc. | 2004-05-14 |
| HIRESOLUTION & CLARION CII BIONIC EAR SYSTEMS (P960058/S035) | Advanced Bionics | 2004-05-14 |
| ENDOTAK, ENDOTAK ENDURANCE, ENDOTAK RELIANCE (P910073/S045) | Boston Scientific | 2004-05-14 |
| ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS AND CALIBRATORS (P030029) | Siemens Healthcare Diagnostics | 2004-05-14 |
| CARDIOSEAL SEPTAL OCCLUSION SYSTEM (P000049/S013) | Nmt Medical, Inc. | 2004-05-14 |
| VENTAK PRX,VENTAK MINI (P910077/S045) | Boston Scientific | 2004-05-14 |
| MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH MED-EL CI.STUDIO+ RELEASE VERSION 2.0 SOFTWARE (P000025/S012) | Med-El Corp. | 2004-05-14 |
| VIGOR, DISCOVERY, MERIDIAN (P940031/S031) | Boston Scientific | 2004-05-14 |
| SWEET TIP RX,SWEET PICOTIP RX,FLEXTEND (P960006/S010) | Boston Scientific | 2004-05-14 |
| TAXUS EXPRESS 2 CORONARY STENT SYSTEM (P030025/S003) | Boston Scientific Corp | 2004-05-14 |
| VENTAK P (P890061/S014) | Boston Scientific | 2004-05-14 |
| FINELINE,FINELINE II (P960004/S025) | Boston Scientific | 2004-05-14 |
| SELUTE,SELUTE PICOTIP (P950001/S011) | Boston Scientific | 2004-05-14 |
| VENTAK P2,VENTAK P3 (P930035/S012) | Boston Scientific | 2004-05-14 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATORS (P000014/S007) | Ortho-Clinical Diagnostics, Inc. | 2004-05-14 |
| VENTAK BIPOLAR ENDOCARDIAL LEADS (P830060/S054) | Boston Scientific | 2004-05-14 |
| ANTHEM AND FRONTIER II CRT-P'S (P030035) | ABBOTT MEDICAL | 2004-05-13 |
| HOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM WITH MODEL 3180-T TRANSMITTER AND MODEL 3180-R RECEIVER SOFTWARE (VERS (P910023/S073) | ABBOTT MEDICAL | 2004-05-12 |
| SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P010017/S004) | Hologic, Inc. | 2004-05-12 |
| COSMODERM AND COSMOPLAST HUMAN-BASED COLLAGEN (P800022/S052) | Allergan | 2004-05-11 |
| RESTYLANE INJECTABLE GEL (P020023/S006) | Q-Med AB | 2004-05-10 |
| RESTYLANE INJECTABLE GEL (P020023/S005) | Q-Med AB | 2004-05-10 |
| CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD (P000049/S012) | Nmt Medical, Inc. | 2004-05-10 |
| WALLSTENT (TIPS AND VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P980033/S010) | Boston Scientific Corporation | 2004-05-07 |
| AMS SPHINCTER 800 URINARY PROSTHESIS (P000053/S004) | Boston Scientific Corp | 2004-05-07 |
| WALLSTENT (TIPS AND VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031/S021) | Boston Scientific Corp | 2004-05-07 |
| EXOGEN 2000+ (P900009/S019) | Bioventus, LLC | 2004-05-07 |
| ABBOTT ARCHITECT FREE PSA (P980007/S004) | Abbott Laboratories | 2004-05-07 |
| AMPLICOR HCV TEST,VERSION 2.0 (P000010/S003) | Roche Molecular Systems, Inc. | 2004-05-06 |
| TAXUS EXPRESS2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS (P030025/S002) | Boston Scientific Corp | 2004-05-05 |
| POSSIS ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S007) | Boston Scientific Corp | 2004-05-05 |
| EXPRESS2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS (P020009/S015) | Boston Scientific Scimed, Inc. | 2004-05-05 |
| GENESIS NEUROSTIMULATION (IPG) SYSTEM (P010032/S011) | ABBOTT MEDICAL | 2004-05-05 |
| RESTYLANE INJECTABLE GEL (P020023/S004) | Q-Med AB | 2004-05-05 |
| VITALITY 2 SYSTEM GUIDE (P960040/S043) | Boston Scientific | 2004-05-04 |