| RAY THREADED FUSION CAGE (TFC) (P950019/S015) | Stryker Spine | 2003-09-04 |
| GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM (P000052/S020) | Guidant Corp. | 2003-09-03 |
| NC MONORAIL PTC CATHETER, QUANTUM MONORAIL PTCA CATHETER, MAXXUM PTCA CATHETER, VIVA PTCA CATHETER AND ADANTE PTCA CATHR (P860019/S198) | Scimed Life Systems, Inc. | 2003-09-03 |
| EXPRESS/EXPRESS2 CORONARY STENT SYSTEM (P020009/S010) | Boston Scientific Scimed, Inc. | 2003-09-03 |
| MAVERICK MONORAIL/QUANTUM MAVERICK MONORAIL PTCA CATHETERS (P860019/S197) | Scimed Life Systems, Inc. | 2003-09-03 |
| BAYER ADVIA IMS PSA ASSAY (P950021/S006) | Siemens Healthcare Diagnostics | 2003-09-02 |
| CHILLI II COOLED ABLATION CATHETERS (P980003/S007) | Boston Scientific Corp | 2003-09-02 |
| ACRYSOF NATURAL SINGLE PIECE INTRAOCULAR LENS (P930014/S012) | Alcon Laboratories, Inc. | 2003-09-02 |
| LIFE VEST, MODEL WCD 3000 (P010030/S004) | Zoll Manufacturing Corporation | 2003-09-02 |
| PROSTAR XL 8 AND 10 FRENCH, CLOSER, CLOSER S, PERCLOSE AT, AND PERCLOSE AT MONOFILAMENT 6 FRENCH SUTURE MEDIATED CLOSER (P960043/S047) | Abbott Vascular, Inc. | 2003-09-02 |
| BAYER ADVIA IMS CPSA ASSAY (P990055/S007) | Siemens Healthcare Diagnostics | 2003-09-02 |
| ANEURX STENT GRAFT WITH XPEDIRNT DELIVERY SYSTEM (P990020/S016) | Medtronic Vascular | 2003-08-29 |
| ACRYSOF SINGLE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) WITH THE ACRYSERT DELIVERY SYSTEM (P930014/S011) | Alcon Laboratories, Inc. | 2003-08-29 |
| ARRAY 2 MODEL SA44 MULTIFOCAL INTRAOCULAR LENS (IOL) (P960028/S009) | Johnson & Johnson Surgical Vision, Inc. | 2003-08-29 |
| GLUCOWATCH G2 BIOGRAPHER (P990026/S019) | Animas Corp. | 2003-08-28 |
| FX MINIRAIL RX PTCA CATHETER (P020037/S001) | Abbott Vascular, Inc. | 2003-08-28 |
| MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S009) | Med-El Corp. | 2003-08-27 |
| DURASPHERE EXP (P980053/S006) | Carbon Medical Technologies, Inc. | 2003-08-26 |
| EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM (P020025) | Boston Scientific | 2003-08-25 |
| ARRAY MULTIFOCAL UV-ABSORBING SILICONE POSTERIOR CHAMBER IOLS (P960028/S010) | Johnson & Johnson Surgical Vision, Inc. | 2003-08-25 |
| MODEL 5076 CAPSURE FIX NOVUS ELECTRODE (P930039/S016) | Medtronic, Inc. | 2003-08-25 |
| UV-ABSORBING SILICONE POSTERIOR CHAMBER IOLS (P880081/S029) | Johnson & Johnson Surgical Vision, Inc. | 2003-08-25 |
| CARDIOVERSION SWITCHBOX II SYSTEM (P020052/S001) | St Jude Medical | 2003-08-22 |
| NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT (ABI) (P000015/S005) | Cochlear Americas | 2003-08-22 |
| CARPENTIER-EDWARDS BIOPROSTHESES, MODELS 2625 (AORTIC) & 6625 (MITRAL), AND CARPENTIER-EDWARDS BIOPROSTHETIC VALVED COND (P870056/S015) | Edwards Lifesciences, LLC | 2003-08-22 |
| GENESIS NEUROSTIMULATION (IPG) SYSTEM (P010032/S008) | ABBOTT MEDICAL | 2003-08-22 |
| AMPLATZER SEPTAL OCCLUDER AND PFO OCCLUDER AMPLATZER 45 DEGREE DELIVERY AND EXANGE SYSTEMS (P000039/S006) | ABBOTT MEDICAL | 2003-08-21 |
| DIASORIN ETI-MAK-2 PLUS ASSAY (P990038/S005) | DiaSorin, Inc. | 2003-08-20 |
| SURGICEL/SURGICEL NU-KNIT/SURGICEL FIBRILLAR ABSORBABLE HEMOSTAT (N12159/S018) | ETHICON, Inc. | 2003-08-20 |
| GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER (P990026/S020) | Animas Corp. | 2003-08-20 |
| AMVISC & AMVISC PLUS (P810025/S022) | Bausch & Lomb, Inc. | 2003-08-19 |
| ADX PULSE GENERATOR FIRMWARE ANOMALY CORRECTION (P880086/S095) | ABBOTT MEDICAL | 2003-08-15 |
| MENTOR SPECTRUM SALINE-FILLED MAMMARY PROSTHESES (P990075/S012) | Mentor Worldwide, LLC | 2003-08-15 |
| ADX PULSE GENERATOR (P910023/S068) | ABBOTT MEDICAL | 2003-08-15 |
| ADX PULSE GENERATOR (P830045/S087) | St. Jude Medical, Inc. | 2003-08-15 |
| NEUROCYBERNETIC PROTHESIS (NCP) SYSTEM (P970003/S047) | LivaNova USA, Inc. | 2003-08-14 |
| MENTOR SPECTRUM SALINE-FILLED MAMMARY PROSTHESES (P990075/S013) | Mentor Worldwide, LLC | 2003-08-14 |
| SILICONE INTRAOCULAR LENSES (P910056/S008) | Bausch & Lomb, Inc. | 2003-08-13 |
| SILICONE INTRAOCULAR LENSES (P910061/S009) | Bausch & Lomb | 2003-08-13 |
| POLYMETHYLMETHA-CRYLATE (PMMA) INTRAOCULAR LENSES (IOLS) (P870013/S016) | Bausch & Lomb | 2003-08-13 |
| PMMA POSTERIOR CHAMBER IOL (P790027/S069) | Bausch & Lomb | 2003-08-13 |
| POLYMETHYLMETHA-CRYLATE (PMMA) INTRAOCULAR LENSES (IOLS) (P880090/S018) | Bausch & Lomb, Inc. | 2003-08-13 |
| QUICKSEAL CONTROL ARTERIAL CLOSURE SYSTEM (P010049/S008) | Sub-Q, Inc. | 2003-08-13 |
| POLYMETHYLMETHA-CRYLATE (PMMA) INTRAOCULAR LENSES (IOLS) (P840039/S051) | Bausch & Lomb, Inc. | 2003-08-13 |
| SILICONE INTRAOCULAR LENSES (P910058/S012) | Bausch & Lomb, Inc. | 2003-08-13 |
| POLYMETHYLMETHA-CRYLATE (PMMA) INTRAOCULAR LENSES (IOLS) (P870073/S017) | Bausch & Lomb, Inc. | 2003-08-13 |
| POLYMETHYLMETHA-CRYLATE (PMMA) INTRAOCULAR LENSES (IOLS) (P850059/S024) | Bausch & Lomb Surgical, Inc. | 2003-08-13 |
| POLYMETHYLMETHA-CRYLATE (PMMA) INTRAOCULAR LENSES (IOLS) (P860002/S018) | Bausch & Lomb | 2003-08-13 |
| INDEPENDENCE (TM) IBOT 3000/4000 MOBILITY SYSTEM (P020033) | Independence Technology, LLC | 2003-08-13 |
| HYDROVIEW IOLS (P990014/S003) | Bausch & Lomb, Inc. | 2003-08-13 |
| ST AIA-PACK PA (P910065/S004) | Tosoh Bioscience, Inc. | 2003-08-12 |
| MODEL 3000 SERIES IMPLANTABLE INFUSION PUMPS (P890055/S016) | Intera Oncology | 2003-08-12 |
| S.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM (P020036) | Cordis US Corporation | 2003-08-12 |
| ASCENSION MCP (P000057/S002) | Smith & Nephew, Inc. | 2003-08-11 |
| SECOND LOOK DIGITAL CAD SYSTEM FOR MAMMOGRAPHY (P010034/S003) | Icad, Inc. | 2003-08-11 |
| ANEURX STENT GRAFT WITH XPEDIENT DELIVERY SYSTEM (P990020/S014) | Medtronic Vascular | 2003-08-08 |
| HER OPTION CRYOABLATION THERAPY SYSTEM (P000032/S003) | CooperSurgical, Inc. | 2003-08-08 |
| RAPIDSCREEN RS-2000D (P000041/S002) | Riverain Medical Group | 2003-08-08 |
| SPECTRANECTICS VITESSE COS RX CATHETERS, VITESSE E CATHETERS AND EXTREME OTW CATHETERS (P910001/S024) | Spectranetics Corp. | 2003-08-08 |
| UROLUME ENDOPROSTHESIS (P920023/S016) | Boston Scientific Corp | 2003-08-08 |
| ANCURE SYSTEM (P990017/S038) | Boston Scientific Corp | 2003-08-08 |
| MEDTRONIC KAPPA 900/800 PACEMAKER SERIES (P980035/S019) | Medtronic, Inc. | 2003-08-07 |
| CHILLI COOLED ABLATION SYSTEM (P980003/S008) | Boston Scientific Corp | 2003-08-07 |
| QUANTIFERON-TB ANALYSIS SOFTWARE PROGRAM (P010033/S004) | Qiagen | 2003-08-07 |
| PHILOS DR ACC PACING SYSTEM AND PROGRAMMER SOFTWARE VERSION B-KAC.V.U/1 (P950037/S030) | Biotronik, Inc. | 2003-08-04 |
| ATS OPEN PIVOT BILEAFLET HEART VALVE (P990046/S007) | Medtronic Ats Medical, Inc. | 2003-08-01 |
| WIZARD X-CELL PHOTODYNAMIC THERAPY BALLOON WITH FIBER OPTIC DIFFUSER (P020021) | Cook Endoscopy | 2003-08-01 |
| DIOMED 630 PDT LASER (P990021/S001) | Pinnacle Biologics, Inc. | 2003-08-01 |
| OPTIGUIDE FIBER OPTIC DIFFUSER (DCYL CYLINDRICAL DIFFUSER SERIES) (P940010/S010) | Pinnacle Biologics, Inc. | 2003-08-01 |
| JOMED JOCATH GLADIATOR PTCA CATHETER (OTW) (P910031/S021) | Abbott Vascular Devices | 2003-08-01 |
| CARBOMEDICS CARBO-SEAL VALSALVA ASCENDING AORTIC PROTHESIS (P900060/S025) | Corcym S.r.l. | 2003-08-01 |
| OL 1000, OL 1000 SC, AND SPINALOGIC BONE GROWTH STIMULATORS (P910066/S017) | Djo, LLC | 2003-08-01 |
| VIEWPOINT CK SYSTEM (P010018/S004) | Refractec, Inc. | 2003-07-31 |
| MARQUIS VR ICD (P980016/S035) | Medtronic Cardiac Rhythm Disease Management | 2003-07-30 |
| PROCOL VASCULAR BIOPROSTHESIS (P020049) | LeMaitre Vascular, Inc. | 2003-07-29 |
| KENTROX RV 65, KENTROX RV 75, KAINOX SL 65/13, KAINOX SL 65/18 (P980023/S013) | Biotronik, Inc. | 2003-07-29 |
| EXPRESS/EXPRESS2 CORONARY STENT SYSTEM (P020009/S009) | Boston Scientific Scimed, Inc. | 2003-07-25 |
| CARBOMEDICS PROSTHETIC HEART VALVE {CPHV} (P900060/S026) | Corcym S.r.l. | 2003-07-25 |
| PTCA CATHETERS (P860019/S196) | Scimed Life Systems, Inc. | 2003-07-25 |
| NIR PREMOUNTED STENT DELIVERY SYSTEMS (P980001/S043) | Boston Scientific Corp | 2003-07-25 |
| MED-EL COMBI 40+ (P000025/S010) | Med-El Corp. | 2003-07-25 |
| GALILEO AND GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS (P000052/S019) | Guidant Corp. | 2003-07-24 |
| PMMA IOL'S: MODELS EZE-50, 55, 60, 65, 70, P359UV, P366UV, IO359, IO379, S122UV AND L122UV (P880090/S019) | Bausch & Lomb, Inc. | 2003-07-23 |
| BIOBURDEN TESTING (P840039/S052) | Bausch & Lomb, Inc. | 2003-07-23 |
| BIOBURDEN TESTING (P910061/S010) | Bausch & Lomb | 2003-07-23 |
| MCGHAN SALINE-FILLED BREAST IMPLANTS (P990074/S015) | Allergan | 2003-07-22 |
| ACS MULTI-LINK DUET CORONARY STENT SYSTEM (P970020/S043) | Abbott Vascular, Inc. | 2003-07-22 |
| MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S011) | Med-El Corp. | 2003-07-22 |
| MEDTRONIC ISOMED MODEL 8472 FIXED RATE INFUSION SYSTEM (P990034/S004) | Medtronic, Inc. | 2003-07-21 |
| SPRINT QUATTRO STEROID-ELUTING LEAD MODEL 6944 (P920015/S028) | Medtronic, Inc. | 2003-07-21 |
| INSYNC II MARQUIS MODEL 7289 WITH MODEL 9989 APPLICATION SOFTWARE (P010031/S005) | Medtronic Cardiac Rhythm Disease Management | 2003-07-21 |
| NOVOSTE BETA-CATH 3.5F SYSTEM (P000018/S029) | Best Vascular, Inc. | 2003-07-18 |
| CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S004) | Bayer Pharma AG | 2003-07-17 |
| MULTI-LINK RX ZETA CORONARY STENT SYSTEM (P970020/S044) | Abbott Vascular, Inc. | 2003-07-16 |
| LADARVISION 4000 EXCIMER LASER SYSTEM (P970043/S013) | Alcon Laboratories | 2003-07-16 |
| MULTI-LINK VISION/MINI/8 CORONARY STENT SYSTEMS (P020047) | Abbott Vascular | 2003-07-16 |
| CORDIS PALMAZ BALLOON EXPANDABLE STENTS (P890017/S011) | Cordis US Corporation | 2003-07-15 |
| RAY TFC UNITE PRODUCT LINE (P950019/S013) | Stryker Spine | 2003-07-15 |
| MENTOR TITAN INFLATABLE PENILE PROSTHESIS (P000006/S003) | Coloplast Corp. | 2003-07-14 |
| GYNECARE THERMACHOICE II UTERINE BALLOON THERAPY SYSTEM (P970021/S008) | Gynecare, Inc. | 2003-07-14 |