| UREA-SL ASSAY CATALOGUE NUMBER 239-10, 239-30 (K973931) | Diagnostic Chemicals , Ltd. | 1997-11-24 |
| PRE-FILLED SYRINGE FOR KOALA IUP (K973746) | Clinical Innovations, Inc. | 1997-11-24 |
| SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENT (K974050) | Beckman Instruments, Inc. | 1997-11-24 |
| VERY PRIVATE INTIMATE MOISTURE (K971793) | Brandwynne Corp. | 1997-11-24 |
| SENDAX MDI (MINI DENTAL IMPLANT) (K972351) | Sendax Mdic Management, Inc. | 1997-11-24 |
| CHARTERMED TPN-EVA BAGS (K973103) | Chartermed, Inc. | 1997-11-24 |
| WILSON-COOK STRICTURE MEASURING CATHETER (K973205) | Wilson-Cook Medical, Inc. | 1997-11-24 |
| BOSTON LIQUID ENZYMATIC CLEANER (K973217) | Polymer Technology Corp. | 1997-11-24 |
| J-TIP INJECTOR (K973254) | National Medical Products, Inc. | 1997-11-24 |
| KARL STORZ DIRECT COUPLED CAMERA HEAD (K973252) | Karl Storz Imaging, Inc. | 1997-11-24 |
| FLUORO-TEX SURGICAL MEMBRANE (K973178) | Bridger Biomed, Inc. | 1997-11-24 |
| SOFTFORM FACIAL IMPLANT (K973462) | Tissue Technologies, Inc. | 1997-11-24 |
| PROSPECTOR PLUS (CODE NAME : RD-0508) (K973881) | J.F. Jelenko & Co., Inc. | 1997-11-24 |
| NEXGEN COMPLETE KNEE SOLUTION CONVEX INSET PATELLA COMPONENT (K972270) | Zimmer, Inc. | 1997-11-24 |
| WHITESIDE BIOMECHANICS, INC. CERAMIC UNIPOLAR FEMORAL HEAD (K973261) | Whiteside Biomechanics, Inc. | 1997-11-24 |
| VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS) (K973558) | Ultracell Medical Technologies, Inc. | 1997-11-24 |
| EXTEND HIP STEM (K973296) | Wrightmedicaltechnologyinc | 1997-11-24 |
| 17 B-ESTRADIOL (ELISA) (K973901) | Kmi Diagnostics, Inc. | 1997-11-24 |
| SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT (K973696) | Beckman Instruments, Inc. | 1997-11-24 |
| PERIPHERALLY INSERTED CENTRAL (K971999) | B.Braun Medical, Inc. | 1997-11-24 |
| PROVIL NOVO (K973694) | Heraeus Kulzer, Inc. | 1997-11-24 |
| DOW CORNING SILASTIC ELASTOMER Q7-4750 (K973166) | Technical Products, Inc. | 1997-11-21 |
| TRITEST REAGENT CD3 FITC/CD8 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES (K970326) | Becton Dickinson Immunocytometry Systems | 1997-11-21 |
| SMARTVIEW OPTIONS FOR HISPEED CT/I (K973168) | GE Medical Systems | 1997-11-21 |
| SEIZURE EMERGENCY EQUIPMENT KIT; SEIZURE KIT (K973176) | Lotus Technologies | 1997-11-21 |
| VARIAN MULTILEAF COLLIMATOR WITH DYNAMIC ARC THERAPY FEATURE (K973889) | Varian Medical Systems, Inc. | 1997-11-21 |
| DIGITAL ADD-ON BUCKY (K970136) | Swissray Teleray AG | 1997-11-21 |
| ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM) (K973369) | Roche Diagnostic Systems, Inc. | 1997-11-21 |
| ACCUPROBE 450, ACCUPROBE 550/530 AND THE ACCUPROBE 600 SERIES (K973190) | Cryomedical Sciences, Inc. | 1997-11-21 |
| URESIL GUIDEWIRE (K972582) | Uresil Corp. | 1997-11-21 |
| ELECSYS AFP (K973351) | Boehringer Mannheim Corp. | 1997-11-21 |
| REFLECTIONS (K973776) | Cdb Corp. | 1997-11-21 |
| GREATBATCH SCIENTIFIC MR COMPATIBLE ARTHROSCOPES AND SMALL JOINT ARTHROSCOPES (K971781) | Wilson Greatbatch Technologies, Inc. | 1997-11-21 |
| PROSTATE SEEDING NEEDLE (K973184) | Promex, Inc. | 1997-11-21 |
| FLEXTIP GRASPER (K972450) | Endius, Inc. | 1997-11-21 |
| ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100 (K973642) | Instrumentarium Imaging, Inc. | 1997-11-21 |
| STEALTHSTATION SYSTEM (K974161) | Surgical Navigation Technologies, Inc. | 1997-11-21 |
| SYNTAC SPRINT (K973397) | Ivoclar North America, Inc. | 1997-11-21 |
| SPIROSAFE FILTER (K973314) | Micro Direct, Inc. | 1997-11-21 |
| HIGH RISK POWDERFREE LATEX EXAMINATION GLOVES (BLUE COLOUR) (K973801) | Sri Johani Sdn. Bhd. | 1997-11-21 |
| OLYMPUS SUBFASCIAL ENDOSCOPIC PERFORATING VEIN SURGERY (SEPS) SYSTEM, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT (K973232) | Olympus Winter & Ibe GmbH | 1997-11-21 |
| HIGH RISK POWDERED LATEX EXAMINATION GLOVES (BLUE COLOUR) (K973815) | Sri Johani Sdn. Bhd. | 1997-11-21 |
| K-PISTON WITH BAND HOOK /ANGULAR PISTON (K973356) | Heinz Kurz | 1997-11-21 |
| LUXSCOPE (K973193) | Luxtec Corp. | 1997-11-21 |
| GIOTTO HT (K973856) | Sitco, Inc. | 1997-11-21 |
| TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP; TRUCOUNT ABSOLUTE COUNT TUBES (K965053) | Becton Dickinson Immunocytometry Systems | 1997-11-21 |
| ACETABULAR SHELLS WITH MESH INGROWTH SURFACE (K973163) | Howmedica Corp. | 1997-11-21 |
| MACOM (K973148) | A.Stein - Regulatory Affairs Consulting | 1997-11-20 |
| AL-47 (ISOFILCON) SOFT (SPHERICAL) DAILY WEAR CONTACT LENS (K973597) | Martin Dalsing | 1997-11-20 |
| ORTHOPEDIC SCREW SYSTEM (K972217) | Ferguson Medical | 1997-11-20 |
| CARMEDA COATED CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS (CBCTXXX SERIES AND CBCTXXXBR SERIES) (K973475) | Medtronic Vascular | 1997-11-20 |
| EPOCH 2000 NEUROLOGICAL WORKSTATION (K971819) | Axon Systems, Inc. | 1997-11-20 |
| FLUID CENTURION (4-100-00) (K973025) | Northgate Technologies, Inc. | 1997-11-20 |
| FLEXLENS, FLEXLENS TORIC (K973192) | Specialty Ultravision, Inc. | 1997-11-20 |
| SYNTHES PROXIMAL FEMORAL NAIL(PFN) SYSTEM MODIFICATION (K973240) | Synthes (Usa) | 1997-11-20 |
| QUICKIE ZIPPIE SERIES, QUICKIE BREEZY SERIES, QUICK FOLDING SERIES, QUICKIE RIGID SERIES (K973673) | Sunrise Medical, Inc. | 1997-11-20 |
| KLS-MARTIN INTRAORAL DISTRACTOR (K973275) | KLS-Martin L.P. | 1997-11-20 |
| ORTHOPEDIC PLATE SYSTEM (K972219) | Ferguson Medical | 1997-11-20 |
| IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT (K973813) | Beckman Instruments, Inc. | 1997-11-20 |
| S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD (K973307) | Johnson & Johnson Professionals, Inc. | 1997-11-20 |
| HOFFMANN II COMPACT PERIARTICULAR CLAMP (K973321) | Howmedica, Inc. | 1997-11-20 |
| KNIGHT LIGHT NONLUBRICATED CONDOM (K960552) | Global Protection Corp. | 1997-11-20 |
| VARIABLE PARALLEL PIN (K973521) | Sulzer Calcitek, Inc. | 1997-11-20 |
| AUTODELFIA NEONATAL HTSH L KIT (B077-112) (K973276) | Eg &G Wallac | 1997-11-20 |
| THE CORIFIX DYNAMIC HIP SCREW SYSTEM (K973231) | Corin USA | 1997-11-20 |
| VENNETO (K974045) | Amsure Sports, Inc. | 1997-11-20 |
| DUAL RADIATION TARGETING SYSTEM DRTS DRAPE (K973162) | Hogan & Hartson | 1997-11-20 |
| NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES (K973529) | Medicotest A/S | 1997-11-20 |
| MARKMAN TEMPLATE SYSTEM (K970306) | Barry Markman, M.D. | 1997-11-20 |
| HEMOCHRON CITRATE APTT (K972831) | International Technidyne Corp. | 1997-11-20 |
| HOWMEDICA TOTAL STABILIZER KNEE COMPONENTS (K973164) | Howmedica Corp. | 1997-11-20 |
| TECA MYOJECT DISPOSABLE NEEDLE ELECTRODES (K973444) | Medelec, Inc. D.B.A. Teca Corp. | 1997-11-20 |
| TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODES (K973442) | Medelec, Inc. D.B.A. Teca Corp. | 1997-11-20 |
| CTF SYSTEMS INC, WHOLE-CORTEX MEG SYSTEM (WITH OPTIONAL EEG SUBSYSTEM) (K971329) | Ctf Systems, Inc. | 1997-11-20 |
| STABILOR HN (K973288) | Degussa Corp. | 1997-11-19 |
| IMTEC BONE COLLECTOR SYSTEM (K973248) | Imtec Corp. | 1997-11-19 |
| SKAR-KARE (K973271) | Target Health, Inc. | 1997-11-19 |
| MEDIMAGE (K972215) | Vepro - Computersysteme GmbH | 1997-11-19 |
| GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE (K970619) | Wilson Greatbatch Technologies, Inc. | 1997-11-19 |
| KNOTT NG TUBE (K971354) | Michael M. Knott, M.D. | 1997-11-19 |
| RENEGADE FIBER BRAIDED MICROCATHETER (K973645) | Boston Scientific Corp | 1997-11-19 |
| IMATION SE-204 LASER IMAGER (K972822) | Imation Enterprises Corp. | 1997-11-19 |
| LMI IRRIGATION CATHETER (IGR) (K972623) | Lucas Medical, Inc. | 1997-11-19 |
| G.E.M. WATER SYSTEMS, INTERNATIONAL (K970674) | G.E.M. Water Systems | 1997-11-19 |
| CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER (K974190) | Consolidated Products & Services, Inc. | 1997-11-19 |
| TIMESH TITANIUM MINI-SOFTPLATE AND MICRO-SOFT PLATE/SCREW SYSTEM (K973145) | Sofamor Danek USA,Inc. | 1997-11-19 |
| BLUE MAX - 20 BALLOON DILATATION CATHETER (K972357) | Boston Scientific Corp | 1997-11-19 |
| FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA 56,57,58,59, SUPREMA 45, 46, 47,48 (K973861) | Magnatone Hearing Aid Corp. | 1997-11-19 |
| SYNTEC TRUE LIGHT END IRRIGATING ENDOILLUMINATOR (K973293) | Vaughan Weeks | 1997-11-18 |
| EXPERT-XL ORTHOPEDIC HIP ACQUISITION AND ANALYSIS SOFTWARE (K972517) | Lunar Corp. | 1997-11-18 |
| IMTEC BONE TAC (K973180) | Imtec Corp. | 1997-11-18 |
| VINYL PATIENT EXAMINATION GLOVES POWDERED (K973902) | Everrise Glove Products Co., Ltd. | 1997-11-18 |
| TEMPO 4 ANGIOGRAPHY CATHETER (VARIOUS) (K973401) | Cordis Corp. | 1997-11-18 |
| DISPOSABLE SILICONE EPISTAXIS CATHETER (K973656) | Specialty Surgical Products, Inc. | 1997-11-18 |
| SUNGLASSES (K973934) | Elegance Optical Manufactory, Ltd. | 1997-11-18 |
| ELVIS HSV ID/TYPING TEST SYSTEM (K971662) | Diagnostic Hybrids, Inc. | 1997-11-18 |
| OLYMPUS NA-10J-1 ASPIRATION NEEDLE (K973128) | Olympus America, Inc. | 1997-11-18 |
| SAFPACE SYSTEM (K955829) | B.Braun Medical, Inc. | 1997-11-18 |
| INTERAX TOTAL KNEE SYSTEM (K973121) | Howmedica Corp. | 1997-11-18 |
| SIMPULSE (K972549) | Kinetic Concepts, Inc. | 1997-11-18 |