| BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053/S003) | Stryker Corporation | 2002-12-31 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS (P870077/S014) | Edwards Lifesciences, LLC | 2002-12-31 |
| THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S024) | Thoratec Laboratories Corp. | 2002-12-31 |
| DERMABOND(R) TOPICAL SKIN ADHESIVE/HIGH VISCOSITY (P960052/S004) | Closure Medical Corp. | 2002-12-31 |
| CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS (P010041/S003) | Edwards Lifesciences, LLC | 2002-12-31 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S020) | Edwards Lifesciences, LLC | 2002-12-31 |
| CARPENTIER-EDWARDS BIOPROSTHESIS (P870056/S016) | Edwards Lifesciences, LLC | 2002-12-31 |
| GLUCOWATCH G2 BIOGRAPHER (P990026/S016) | Animas Corp. | 2002-12-31 |
| FINISHING WIRE UNIVERSAL (P010012/S005) | Boston Scientific Corp | 2002-12-30 |
| NUCLEUS 22 COCHLEAR IMPLANT FOR CHILDREN (P890027/S055) | Cochlear Americas | 2002-12-27 |
| NUCLEUS 22 COCHLEAR IMPLANT SYSTEM (ADULTS) (P840024/S086) | Cochlear Americas | 2002-12-27 |
| GENESIS G4 NEUROSTIMULATION(IPG)SYSTEM(MODEL 3604) (P010032/S006) | ABBOTT MEDICAL | 2002-12-23 |
| ANEURX STENT GRAFT SYSTEM (P990020/S010) | Medtronic Vascular | 2002-12-23 |
| ATTAIN OTW 4193 LEFT VENTRICULAR PACING LEAD (P010015/S007) | Medtronic, Inc. | 2002-12-23 |
| ADATO SIL-OL 5000 SILICONE OIL SYRINGE (P910071/S006) | Bausch & Lomb | 2002-12-23 |
| CARDIOSEAL SEPTAL OCCLUSION SYSTEM W/QWIK LOAD (P000049/S007) | Nmt Medical, Inc. | 2002-12-23 |
| PROSTALUND CORETHERM SYSTEM MICROWAVE THERMOTHERAPY FOR BPH (P010055) | Prostalund AB | 2002-12-23 |
| GENESIS NEUROSTIMULATION (IPG) SYSTEM (P010032/S005) | ABBOTT MEDICAL | 2002-12-23 |
| IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P000009/S006) | Biotronik, Inc. | 2002-12-20 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS PLATFORM (P930038/S034) | Terumo Medical Corporation | 2002-12-20 |
| PROTOS FAMILY OF PULSE GENERATORS (P950037/S029) | Biotronik, Inc. | 2002-12-20 |
| UVAR XTS PHOTOPHERESIS SYSTEM (P860003/S042) | Therakos Development Limited | 2002-12-20 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS PLATFORM (P930038/S035) | Terumo Medical Corporation | 2002-12-20 |
| PERMANENT PACEMAKER ELECTRODE (P820076/S023) | Biotronik, Inc. | 2002-12-20 |
| IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD'S) (P980023/S011) | Biotronik, Inc. | 2002-12-20 |
| SUTURE TRIMMER FOR THE CLOSER II 6FR. SUTURE-MEDIATED CLOSURE (SMC) SYSTEM (P960043/S043) | Abbott Vascular, Inc. | 2002-12-20 |
| BELOS DR AND BELOS DR-T DUAL-CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEMS (P000009/S005) | Biotronik, Inc. | 2002-12-20 |
| CONTAK RENEWAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) (P010012/S002) | Boston Scientific Corp | 2002-12-20 |
| MEDTRONIC AVE BRIDGE EXTRA SUPPORT OVER THE WIRE RENAL STENT SYSTEM (P020007) | Medtronic Vascular | 2002-12-18 |
| TALENT II DUAL-SENSOR IMPLANTABLE CARDIAC PACEMAKERS, MODELS DR233 AND SR133 (P950029/S016) | MicroPort CRM USA, Inc. | 2002-12-18 |
| QWIKSTAR DIAGNOSTIC/ABLATION CATHETERS (MODELS D-1229 AND D-1230) AND QWIKSTAR INTERFACE CABLE (MODEL D-1195-12) (P990025/S004) | Biosense Webster, Inc. | 2002-12-18 |
| DEFLUX INJECTABLE GEL (P000029/S002) | Palette Life Sciences | 2002-12-18 |
| NC BIG RANGER PTCA CATHETER (P860019/S192) | Scimed Life Systems, Inc. | 2002-12-17 |
| GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM (P000052/S014) | Guidant Corp. | 2002-12-17 |
| NELLCOR PURITAN BENNETT INFANT STAR HIGH FREQUENCY VENTILATOR (P880013/S009) | Nellcor Puritan Bennett, Inc. | 2002-12-17 |
| LCS TOTAL KNEE SYSTEM (P830055/S083) | Depuy, Inc. | 2002-12-17 |
| MEDTRONIC MODEL 4819 ABLATION CATHETER TO EP RECORDING SYSTEM CABLE (P930029/S018) | Medtronic, Inc. | 2002-12-17 |
| PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM, PORT-A-CATH EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM (P900052/S012) | Smiths Medical Asd, Inc. | 2002-12-17 |
| MEDTRONIC SYNCHROMED APPLICATION SOFTWARE FOR MODEL 8870, MEDTRONIC INFUSION PUMP SYSTEM (P860004/S055) | Medtronic, Inc. | 2002-12-17 |
| QUANTIFERON-TB (P010033/S002) | Qiagen | 2002-12-17 |
| MEDTRONIC MODELS 7230CX, 7230B, AND 7230E MARQUIS VR SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS WITH (P980016/S029) | Medtronic Cardiac Rhythm Disease Management | 2002-12-17 |
| LSX EXCIMER LASER SYSTEM (P980008/S012) | Lasersight Technologies, Inc. | 2002-12-16 |
| VENTAK P2 LEADS AND ACCESSORIES (P930035/S010) | Boston Scientific | 2002-12-13 |
| RES-Q ACCESSORIES (P940008/S017) | Boston Scientific | 2002-12-13 |
| ENDOTAK/ENDURANCE/RELIANCE LEADS AND ACCESSORIES (P910073/S040) | Boston Scientific | 2002-12-13 |
| SELUTE LEADS AND ACCESSORIES (P950001/S009) | Boston Scientific | 2002-12-13 |
| VENTAK PRX LEADS AND ACCESSORIES (P910077/S038) | Boston Scientific | 2002-12-13 |
| SWEETIP RX/SWEET PICOTIP RX/FLEXTEND (P960006/S007) | Boston Scientific | 2002-12-13 |
| DEFLUX INJECTABLE GEL (P000029/S003) | Palette Life Sciences | 2002-12-13 |
| CONTAK CD/EASYTRAK LEADS & ACCESSORIES (P010012/S006) | Boston Scientific Corp | 2002-12-13 |
| VENTAK LEADS AND ACCESSORIES (P830060/S051) | Boston Scientific | 2002-12-13 |
| THINLINE/FINELINE LEADS AND ACCESSORIES (P960004/S021) | Boston Scientific | 2002-12-13 |
| DAKO HERCEPTEST (P980018/S001) | Agilent Technologies Singapore (International) Pte , Ltd. | 2002-12-12 |
| KARL STORZ AUTOFLUORESCENCE SYSTEM (P020008) | KARL STORZ Endoscopy-America, Inc. | 2002-12-12 |
| GALILEO AND GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS (P000052/S009) | Guidant Corp. | 2002-12-10 |
| PERFLUOROPROPANE FOR PNEUMATIC RETINOPEXY (P900066/S006) | Airgas Therapeutics, LLC | 2002-12-10 |
| CARBOMEDICS CARBO-SEAL VALSALVA ASCENDING AORTIC PROSTHESIS (P900060/S024) | Corcym S.r.l. | 2002-12-10 |
| MENICON SF-P (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS (P880098/S012) | Menicon Co, Ltd. | 2002-12-10 |
| NUCLEUS 22 COCHLEAR IMPLANT SYSTEM FOR ADULTS (P840024/S084) | Cochlear Americas | 2002-12-09 |
| NUCLEUS 22 COCHLEAR IMPLANT FOR CHILDREN (P890027/S053) | Cochlear Americas | 2002-12-09 |
| NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM (P000015/S003) | Cochlear Americas | 2002-12-09 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S023) | Cochlear Americas | 2002-12-09 |
| ACCESS AFP ASSAY ON THE SYNCHRON LXI 725 SYSTEM (P980041/S002) | Beckman Coulter, Inc. | 2002-12-06 |
| MODEL SPF-60 SPINAL FUSION STIMULATOR (P850035/S029) | Ahp Eos Buyer, Inc. | 2002-12-06 |
| DISCRETE TECHNOLOGY OVER-THE-WIRE CORONARY STENT SYSTEMS (P970035/S041) | Medtronic, Ireland | 2002-12-06 |
| HOME ACCESS HEPATITIS C TEST SERVICE (P980046/S005) | Pwn Health Chicago, LLC | 2002-12-06 |
| PROTOS PULSE GENERATOR (PROTOS VR AND PROTOS DR) AND B-K00.P.U AND A-K00.0.U PROGRAMMER SOFTWARE (P950037/S028) | Biotronik, Inc. | 2002-12-06 |
| AFFINITY ANTERIOR CERVICAL CAGE SYSTEM (P000028/S002) | Medtronic Sofamor Danek USA, Inc. | 2002-12-03 |
| STAARVISC II,SHELLGEL AND COEASE VISCOELASTICS (P000046/S004) | Anika Therapeutics, Inc. | 2002-12-03 |
| AMVISC AND AMVISC PLUS SODIUM HYALURONATE VISCOELASTICS (P810025/S021) | Bausch & Lomb, Inc. | 2002-12-03 |
| CARDIOGENESIS TMR2000 HOLMIUM LASER SYSTEM (P970029/S006) | Cryolife, Inc. | 2002-12-03 |
| PATHWAY HER 2 (CLONE CB11) (P990081/S001) | Ventana Medical Systems, Inc. | 2002-11-27 |
| QUICKSEAL CCS ARTERIAL CLOSURE SYSTEM (P010049/S003) | Sub-Q, Inc. | 2002-11-27 |
| ALERT SYSTEM (ALERT CATHETER, ALERT INTERFACE CABLE, AND ALERT COMPANION WITH SOFTWARE VERSION 1.08) (P990069) | Dot Medical Products , Ltd. | 2002-11-27 |
| ACCESS HYBRITECH PSA ON THE ACCESS 2 IMMUNOASSAY ANALYZER (P850048/S017) | Beckman Coulter, Inc. | 2002-11-27 |
| ACCESS HYBRITECH FREE PSA ON THE ACCESS 2 IMMUNOASSAY ANALYZER (P970038/S005) | Beckman Coulter, Inc. | 2002-11-27 |
| AUTODELFIA HAFP TEST KIT (P970037/S001) | Revvity, Inc. | 2002-11-27 |
| FRESHLOOK RADIANCE SPHERICAL AND TORIC (PHEMFILCON A) SOFT CONTACT LENSES (P830037/S047) | Alcon Laboratories, Inc. | 2002-11-26 |
| ETI-AB-AUK PLUS (P990042/S005) | DiaSorin, Inc. | 2002-11-26 |
| KAINOX RV-S/ KAINOX VCS ICD LEADS (P980023/S009) | Biotronik, Inc. | 2002-11-25 |
| UVAR XTS PHOTOPHERESIS SYSTEM (P860003/S041) | Therakos Development Limited | 2002-11-25 |
| BOSTON SCIENTIFIC ACE/TRAPPER/SURPASS/REMEDY PTCA CATHETERS (P860019/S190) | Scimed Life Systems, Inc. | 2002-11-25 |
| OXI FIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S009) | Covidien, LLC | 2002-11-25 |
| CLARION CII BIONIC EAR SYSTEM HIFOCUS ELECTRODE (P960058/S028) | Advanced Bionics | 2002-11-25 |
| OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S008) | Covidien, LLC | 2002-11-25 |
| FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT (P990028/S005) | Genzyme Corp. | 2002-11-25 |
| NOVASURE IMPEDANCE CONTROLLED EMDOMETRIAL ABLATION SYSTEM (P010013/S003) | Hologic, Inc. | 2002-11-25 |
| RADIUS CORONARY STENT W/DELIVERY SYSTEM (P970061/S018) | Boston Scientific Scimed, Inc. | 2002-11-25 |
| NUCLEUS 24 CONTOUR ADVANCE (P970051/S021) | Cochlear Americas | 2002-11-22 |
| THE ANEURX STENT GRAFT WITH XPEDIENT DELIVERY SYSTEM (P990020/S009) | Medtronic Vascular | 2002-11-21 |
| MAVERICK OTW, MAVERICK MONORAIL & MAVERICK2 MONORAIL PTCA CATHETERS (P860019/S186) | Scimed Life Systems, Inc. | 2002-11-21 |
| SENOGRAPHE (P990066/S015) | GE Healthcare | 2002-11-21 |
| ICAD (P010038/S002) | Icad, Inc. | 2002-11-20 |
| MAVERICK 2 MONORAIL PTCA CATHETERS (P860019/S179) | Scimed Life Systems, Inc. | 2002-11-20 |
| EXOGEN 2000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (P900009/S014) | Bioventus, LLC | 2002-11-18 |
| GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM (P000052/S012) | Guidant Corp. | 2002-11-18 |
| OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S010) | Covidien, LLC | 2002-11-15 |
| ETI-AB-AUK PLUS ASSAY (P990042/S004) | DiaSorin, Inc. | 2002-11-14 |
| BIODIVYSIO OC/SV OTW STENT DELIVERY SYSTEMS (P000011/S007) | Abbott Vascular, Inc. | 2002-11-14 |
| NAVISTAR DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETER (P950005/S015) | Biosense Webster, Inc. | 2002-11-13 |