| NAVISTAR DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETER (P990025/S005) | Biosense Webster, Inc. | 2002-11-13 |
| NOVOSTE BETA-CATH 3.5F SYSTEM (P000018/S026) | Best Vascular, Inc. | 2002-11-13 |
| PERCLOSE A-T 6 FR. SUTURE MEDICATED CLOSURE (SMC) SYSTEM (P960043/S042) | Abbott Vascular, Inc. | 2002-11-12 |
| ETI-AB-COREK PLUS (P990045/S003) | DiaSorin, Inc. | 2002-11-08 |
| ANCURE SYSTEM (P990017/S036) | Boston Scientific Corp | 2002-11-08 |
| ISOMED IMPLANTABLE FLOW INFUSION PUMP (P990034/S003) | Medtronic, Inc. | 2002-11-08 |
| ETI-HA-IGMK PLUS KIT (P890014/S004) | DiaSorin, Inc. | 2002-11-08 |
| DIASORIN ETI-MAK-2 PLUS (P990038/S003) | DiaSorin, Inc. | 2002-11-08 |
| DIASORIN ETI-AB-HAVK PLUS (P890019/S007) | Diasorin | 2002-11-08 |
| DIASORIN ETI-EBK PLUS (P990043/S003) | DiaSorin, Inc. | 2002-11-08 |
| DIASORIN ETI-CORE-IGMK PLUS (P990044/S002) | DiaSorin, Inc. | 2002-11-08 |
| DIASORIN ETI-AB-EBK PLUS (P990041/S002) | DiaSorin, Inc. | 2002-11-08 |
| VERSANT HCV RNA QUALITATIVE ASSAY (P020011) | Gen-Probe | 2002-11-07 |
| LADARVISION 4000 EXCIMER LASER SYSTEM (P970043/S011) | Alcon Laboratories | 2002-11-07 |
| THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM (SNAP VE LVAS) (P920014/S016) | Thoratec Corp | 2002-11-06 |
| EXCLUDER BIFURCATED ENDOPROSTHESIS (P020004) | W. L. Gore & Associates, Inc. | 2002-11-06 |
| NC MONORAIL/NC BIG RANGER/NC RANGER PTCA CATHETHERS (P860019/S189) | Scimed Life Systems, Inc. | 2002-11-06 |
| HAVAB-M EIA (P790019/S016) | Abbott Laboratories | 2002-11-06 |
| MENICON Z (P990018/S003) | Menicon Co, Ltd. | 2002-11-06 |
| CALRION CII BIONIC EAR SYSTEM (ADULT) (P940022/S027) | Advanced Bionics Corp. | 2002-11-06 |
| CLARION CII BIONIC EAR SYSTEM (PEDIATRIC) (P960058/S027) | Advanced Bionics | 2002-11-06 |
| EXPRESS/EXPRESS 2 CORONARY STENT SYSTEM (P020009/S002) | Boston Scientific Scimed, Inc. | 2002-11-05 |
| ESSURE SYSTEM (P020014) | Bayer Pharma AG | 2002-11-04 |
| BIOLON (1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY) (P960011/S007) | Altacor , Ltd. | 2002-11-01 |
| CLARION CII BIONIC EAR SYSTEM (ADULT) (P940022/S026) | Advanced Bionics Corp. | 2002-11-01 |
| CLARION CII BIONIC EAR SYSTEM (PEDIATRIC) (P960058/S026) | Advanced Bionics | 2002-11-01 |
| MEDTRONIC MODEL 7482 DBS EXTENSION (P960009/S026) | Medtronic, Inc. | 2002-10-31 |
| ITREL II, ITREL 3, SYNERGY AND SYNERGY VERSITREL NEUROSTIMULATORS (P840001/S061) | Medtronic Neuromodulation | 2002-10-31 |
| SOLETRA AND ITREL II NEUROSTIMULATORS FOR DEEP BRAIN STIMULATION (DBS) SOFTWARE (P960009/S025) | Medtronic, Inc. | 2002-10-31 |
| OMNICARBON CARDIAC VALVE PROSTHESIS (P830039/S011) | Medical Cv, Inc. | 2002-10-29 |
| MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM, MED-EL INSERTION TEST DEVICE (ITD) (P000025/S005) | Med-El Corp. | 2002-10-29 |
| MEDTRONIC N'VISION PROGRAMMING SYSTEM AND SYNCHRONMED APPLICATION SOFTWARE (P860004/S052) | Medtronic, Inc. | 2002-10-29 |
| THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S022) | Thoratec Laboratories Corp. | 2002-10-29 |
| RADIUS CORONARY STENT AND DELIVERY CATHETER (P970061/S017) | Boston Scientific Scimed, Inc. | 2002-10-29 |
| ITREL 3, SYNERGY AND SYNERGY VERSITREL NEUROSTIMULATORS (P840001/S066) | Medtronic Neuromodulation | 2002-10-29 |
| HANCOCK II PORCINE BIOPROSTHESIS MODEL T505 (AORTIC) (P980043/S002) | Medtronic, Inc. | 2002-10-28 |
| NIDEK EC-5000 EXCIMER LASER SYSTEM (P970053/S007) | Nidek Co., Ltd. | 2002-10-28 |
| MEDTRONIC AVE S7 ZIPPER MX CORONARY STENT SYSTEM (P970035/S043) | Medtronic, Ireland | 2002-10-28 |
| MOSAIC PORCINE BIOPROSTHESIS MODEL 305 (AORTIC) (P990064/S007) | Medtronic, Inc. | 2002-10-28 |
| VIEWPOINT CK SYSTEM (KERATOPLAST TIP COMPONENT) (P010018/S001) | Refractec, Inc. | 2002-10-28 |
| MEDTRONIC INSYNC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR MODEL 7272 (P010031/S001) | Medtronic Cardiac Rhythm Disease Management | 2002-10-25 |
| BETA-CATH XL DELIVERY CATHETER - 60 MM (P000018/S021) | Best Vascular, Inc. | 2002-10-25 |
| SEPRAFILM ADHESION BARRIER (P950034/S022) | Baxter Healthcare Corporation | 2002-10-25 |
| DILAPAN-S (P840045/S006) | Medicem Technology S.R.O | 2002-10-25 |
| MAVERICK XL PTCA CATHETER (MONORAIL) (P860019/S183) | Scimed Life Systems, Inc. | 2002-10-24 |
| MAVERICK OTW/RANGER PTCA CATHETERS (P860019/S188) | Scimed Life Systems, Inc. | 2002-10-24 |
| QUANTIFERON-TB (P010033/S001) | Qiagen | 2002-10-24 |
| ANEURX STENT GRAFT SYSTEM (P990020/S011) | Medtronic Vascular | 2002-10-24 |
| PTCA CATHETERS, NIR PREMOUNTED STENT DELIVERY SYSTEM, AND EXPRESS/EXPRESS2 CORONARY STENT SYSTEM (P860019/S187) | Scimed Life Systems, Inc. | 2002-10-23 |
| MEDTRONIC MODEL 7272 INSYNC ICD (P010031/S002) | Medtronic Cardiac Rhythm Disease Management | 2002-10-23 |
| ESPRIT/CROSSAIL/OPENSAIL/POWERSAIL/HIGHSAIL CORONARY DILATION CATHETHERS (P810046/S213) | Advanced Cardiovascular Systems, Inc. | 2002-10-23 |
| CARISOLV MINIMAL INVASIVE DENTAL CARIES REMOVAL SYSTEM (P000005/S005) | Rls Global AB | 2002-10-23 |
| PTCA CATHETERS, NIR PREMOUNTED STENT DELIVERY SYSTEM, AND EXPRESS/EXPRESS2 CORONARY STENT SYSTEM (P980001/S041) | Boston Scientific Corp | 2002-10-23 |
| CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIK LOAD (P000049/S005) | Nmt Medical, Inc. | 2002-10-23 |
| PTCA CATHETERS, NIR PREMOUNTED STENT DELIVERY SYSTEM, AND EXPRESS/EXPRESS 2 CORONARY STENT SYSTEM (P020009/S001) | Boston Scientific Scimed, Inc. | 2002-10-23 |
| STOCKERT 70 RF GENERATOR WITH SOFTWARE VERSION 1.033 (P990071/S003) | Biosense Webster, Inc. | 2002-10-21 |
| LADARVISION 4000 EXCIMER LASER SYSTEM (P970043/S010) | Alcon Laboratories | 2002-10-18 |
| MODEL 3000 SERIES IMPLANTABLE INFUSION PUMPS (P890055/S013) | Intera Oncology | 2002-10-18 |
| S7 WITH DISCRETE TECHNOLOGY OVER-THE-WIRE AND RAPID EXCHANGE CORONARY STENT SYSTEM WITH THE AV2000 BALLO0N (P970035/S038) | Medtronic, Ireland | 2002-10-15 |
| APLIGRAF (P950032/S034) | Organogenesis, Inc. | 2002-10-15 |
| ON-X CONFORM-X AORTIC PROSTHETIC HEART VALVE, MODEL ONXAC (P000037/S002) | On-X Life Technologies, Inc. | 2002-10-11 |
| MEDTRONIC INTRATHECAL CATHETER MODEL 8731, MEDTRONIC INFUSION PUMP SYSTEM (P860004/S054) | Medtronic, Inc. | 2002-10-11 |
| COLLAGRAFT STRIP BONE GRAFT MATRIX (P900039/S012) | Neucoll, Inc. | 2002-10-10 |
| THORATEC VENTRICULAR ASSIST DEVICE (P870072/S017) | Thoratec Laboratories Corp. | 2002-10-09 |
| LIFEVEST WCD 3000 SYSTEM (P010030/S001) | Zoll Manufacturing Corporation | 2002-10-09 |
| DRILAC CUBES AND GRANULES (P800012/S010) | Osmed, Inc. | 2002-10-09 |
| SYNCHROMED EL PROGRAMMABLE PUMP (P860004/S053) | Medtronic, Inc. | 2002-10-09 |
| LIFEVEST WCD 3000 SYSTEM (P010030/S003) | Zoll Manufacturing Corporation | 2002-10-09 |
| BIOGLUE SURGICAL ADHESIVE (P010003/S002) | Cryolife, Inc. | 2002-10-08 |
| ACRYSOR SINGLE PIECE POSTERIOR CHAMBER INTRAOCULAR LENS MODEL SA60AT ECTEDED DIOPTER RANGE (P930014/S010) | Alcon Laboratories, Inc. | 2002-10-07 |
| MODELS H115 AND H119 CONTAK CD 2 (CRT-D) CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR SYSTEM (P010012/S004) | Boston Scientific Corp | 2002-10-07 |
| THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S020) | Thoratec Laboratories Corp. | 2002-10-07 |
| MODEL 2844 APPLICATION SOFTWARE, VERSION 3.5 (P960040/S027) | Boston Scientific | 2002-10-07 |
| INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S001) | Medtronic Sofamor Danek USA, Inc. | 2002-10-04 |
| LCS TOTAL KNEE SYSTEM (P830055/S082) | Depuy, Inc. | 2002-10-04 |
| SYNERGY AND SYNERGY VERSITREL NEUROSTIMULATORS (P840001/S065) | Medtronic Neuromodulation | 2002-10-03 |
| PORT-A-CATH EPIDURAL/PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS (P900052/S011) | Smiths Medical Asd, Inc. | 2002-10-03 |
| MEDTRONIC AVE S660 ZIPPER MX CORONARY STENT SYSTEM AND S7 CORONARY STENT WITH ZIPPER DELIVERY SYSTEM (P970035/S042) | Medtronic, Ireland | 2002-10-02 |
| SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P010025/S001) | Hologic, Inc. | 2002-10-02 |
| SCIMED NC RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER (P860019/S180) | Scimed Life Systems, Inc. | 2002-10-01 |
| ACCESS AFP ASSAY ON THE ACCESS 2 IMMUNOASSAY SYSTEMS (P980041/S001) | Beckman Coulter, Inc. | 2002-10-01 |
| QUANTUM MAVERICK MONORAIL/OTW PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETERS (P860019/S182) | Scimed Life Systems, Inc. | 2002-10-01 |
| PREPSTAIN SYSTEM (P970018/S004) | Bd Diagnostic Systems | 2002-10-01 |
| NOVOSTE BETA-CATH SYSTEM (P000018/S024) | Best Vascular, Inc. | 2002-09-30 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S075) | Boston Scientific Corp | 2002-09-30 |
| LIVEWIRE TC CARDIAC ABLATION SYSTEM (P960016/S008) | St Jude Medical | 2002-09-27 |
| EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S017) | Boston Scientific Corp | 2002-09-27 |
| NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER (P010068) | Biosense Webster, Inc. | 2002-09-27 |
| ITREL3, SYNERGY AND SYNERGY VERSITREL NEUROSTIMULATORS (P840001/S064) | Medtronic Neuromodulation | 2002-09-26 |
| SURGIFOAM ABSORBABLE GELATIN POWDER (P990004/S004) | Ferrosan Meidcal Devices A/S | 2002-09-25 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S022) | Cochlear Americas | 2002-09-24 |
| NUCLEUS 22 COCHLEAR IMPLANT SYSTEM/CHILDREN (P890027/S052) | Cochlear Americas | 2002-09-24 |
| SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL Z9000 (P990080/S002) | Johnson & Johnson Surgical Vision, Inc. | 2002-09-24 |
| IMPLANTABLE INFUSION PUMPS (P890055/S015) | Intera Oncology | 2002-09-24 |
| INTERSTIM THERAPY FOR URINARY CONTROL (P970004/S022) | Medtronic Neuromodulation | 2002-09-24 |
| NUCLEUS 22 COCHLEAR IMPLANT SYSTEM/ADULTS (P840024/S083) | Cochlear Americas | 2002-09-24 |
| GLUCOWATCH G2 BIOGRAPHER (P990026/S015) | Animas Corp. | 2002-09-23 |
| BTE FIREFLY (PEDIATRIC) (P960058/S024) | Advanced Bionics | 2002-09-23 |
| CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) (P960058/S025) | Advanced Bionics | 2002-09-23 |
| CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT (P940022/S025) | Advanced Bionics Corp. | 2002-09-23 |