| TEMPERATURE DIAGNOSTIC ACCESSORY (K973764) | New Star Lasers, Inc. | 1997-12-31 |
| KENDALL CURITY IODOFORM PACKING STRIP (K973763) | Kendall Healthcare Products Co. Div.Of Tyco Health | 1997-12-31 |
| SENTINEL RECORDER, MODELS 471/472 (K971696) | Del Mar Avionics | 1997-12-30 |
| MEDRAD 1.5T EXTREMITY ARRAY (K973787) | Medrad, Inc. | 1997-12-30 |
| WELLCOLEX E.COLI O157:H7 (K971663) | Murex Biotech , Ltd. | 1997-12-30 |
| CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY, TUBE HOUSING DIAGNOSTIC, BEAM LIMITING DEVICE, MANUAL (K973833) | Dynarad Corp. | 1997-12-30 |
| EVERYTIME TRANSFUCER COVER (K955893) | Amedic AB | 1997-12-30 |
| INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610 (K971775) | Cardiac Control Systems, Inc. | 1997-12-29 |
| PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS (K973862) | Sims Deltec, Inc. | 1997-12-29 |
| UNICATH SP BI-PLANE (MODEL M269 & M289) (K973744) | Xre Corp. | 1997-12-29 |
| EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391 (K971570) | Quinton Electrophysiology Corp. | 1997-12-29 |
| AESCULAP HILAN MOTOR SYSTEM (K973736) | Aesculap, Inc. | 1997-12-29 |
| DUODERM HYDROACTIVE GEL (K973806) | Convatec, A Bristol-Myers Squibb Co. | 1997-12-29 |
| CODMAN HAKIM MICRO PRECISION VALVE (K973774) | Johnson & Johnson Professionals, Inc. | 1997-12-29 |
| DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1 (K973873) | American Telecare, Inc. | 1997-12-29 |
| FLOSTAT VASCULAR REPORT GENERATOR (VRG) (K973857) | Biomedix, Inc. | 1997-12-29 |
| HI-CARE CLOSED SUCTION SYSTEM (K972258) | Mallinckrodt Medical | 1997-12-29 |
| OMEGA 21 SYSTEM (K973683) | Ebi Electro Biology | 1997-12-24 |
| DURA-GUARD-DURAL REPAIR PATCH (K973706) | Bio-Vascular, Inc. | 1997-12-24 |
| EVERGREEN NON-STERILE POWDERED LATEX EXAMINATION GLOVE (K974191) | Yty Industry (Manjung) Sdn Bhd | 1997-12-24 |
| DURASIL I AND DURASIL II (K973730) | Hanson Medical, Inc. | 1997-12-24 |
| INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERS (K971339) | Becton Dickinson Vascular Access, Inc. | 1997-12-24 |
| VERSYS HIP SYSTEM BEADED HIP PROSTHESIS (K973714) | Zimmer, Inc. | 1997-12-24 |
| POWERFLEX PEC IMPLANT (K973729) | Hanson Medical, Inc. | 1997-12-24 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT (K974110) | Beckman Instruments, Inc. | 1997-12-24 |
| MICRO-STRIP FOR OPIATE METABOLITES (K973761) | Microdiagnostics, Inc. | 1997-12-24 |
| SYSCOS IDC - G, IDC, BSC, IDC - G (K974262) | Scantibodies Laboratory, Inc. | 1997-12-24 |
| BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP PREGNANCY TEST, LIFESIGN HCG-ONE STEP PREGNANCY TEST (K974425) | Princeton BioMeditech Corp. | 1997-12-24 |
| OSOM HCG-URINE TEST MODEL 101 (K974159) | Wyntek Diagnostics, Inc. | 1997-12-24 |
| N.I.T., INC. NEEDLE GUIDING TEMPLATE (K973638) | Avid N.I.T., Inc. | 1997-12-23 |
| INDIGO PORTABLE LASER SYSTEM WITH TEMPERATURE FEEDBACK -MODEL IDL 830 (POWER OPTIONS : 25, 20, 15 & 10 WATTS) INDIGO FIB (K963969) | Indigo Medical, Inc. | 1997-12-23 |
| COMPOUND SULPHONAMIDES ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K971637) | Oxoid , Ltd. | 1997-12-23 |
| DUODERM CONTROL GEL FORMULA BORDER DRESSING (K973688) | Convatec, Ltd. | 1997-12-23 |
| SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA (K974306) | Sangui Biotech, Inc. | 1997-12-23 |
| LORAD M-III ELITE (M-III E) (K973631) | Lorad Corp. | 1997-12-23 |
| DUODERM HYDROACTIVE PASTE (K973807) | Convatec, A Bristol-Myers Squibb Co. | 1997-12-23 |
| MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND:YAG LASER (K973719) | Continuum Biomedical, Inc. | 1997-12-23 |
| LEVO COMPACT-EASY LCE (K973951) | Levo USA | 1997-12-23 |
| FLOSTAT VASCULAR LAB (K973644) | Biomedix, Inc. | 1997-12-23 |
| 3I BIORESORBABLE FIXATION TACK (K972480) | Implant Innovations, Inc. | 1997-12-23 |
| DUODERM HYDROACTIVE DRESSING (K973689) | Convatec, Ltd. | 1997-12-23 |
| INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER (K974048) | Hollister, Inc. | 1997-12-23 |
| HARMONIC IMAGING WITH CONTRAST (K973767) | Acuson Corp. | 1997-12-23 |
| DISTAL CENTRALIZER, EXETER II HIP SYSTEM (K974054) | Howmedica, Inc. | 1997-12-23 |
| LEVO MOBIL LCM (K963817) | Levo USA | 1997-12-23 |
| OLICON IMAGING SYSTEMS, INC. 02-WORKSTATION AND/OR PACSVIEW SOFTWARE (K973959) | Olicon Imaging Systems, Inc. | 1997-12-22 |
| SYNTEX (K971360) | Shinemound Enterprise, Inc. | 1997-12-22 |
| ENDOLAP RESECTOSCOPE CUTTING LOOP ELECTRODE (K974516) | Endolap, Inc. | 1997-12-22 |
| RDI HOMOGENEOUS HDL CHOLESTEROL TEST (K973988) | Reference Diagnostics, Inc. | 1997-12-22 |
| DUODERM CGF CONTROL GEL FORMULA DRESSING (K973632) | Convatec, A Division of E.R. Squibb & Sons | 1997-12-22 |
| NIPRO CORELESS NEEDLE/CORELESS NEEDLE SET (K971582) | Nipro Medical Corp. | 1997-12-22 |
| LIGHTLINE-M (K974240) | Wuestec Medical, Inc. | 1997-12-22 |
| CATHETER TUNNELER (K972555) | Gerard Medical, Inc. | 1997-12-22 |
| GE LOGIQ 500 DIAGNOSTIC ULTRASOUND SYSTEM (K970901) | GE Medical Systems | 1997-12-22 |
| DAXOR MAX100 SYRINGE (MAX100) (K970419) | Daxor Corporation | 1997-12-22 |
| SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL,SINFONY MAGIC MODIFIERS, SINFONY OPAQUER (K973513) | Espe GmbH & Co. Kg. | 1997-12-22 |
| PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL (K974068) | Tecnol Medical Products, Inc. | 1997-12-22 |
| AUKLET CT SCANNER, TSX-003A (K973908) | Toshiba America Medical Systems, In.C | 1997-12-22 |
| TAKY-SPIKE PLUS (K974198) | Clinico | 1997-12-22 |
| ENDOLAP RESECTOSCOPE ROLLER ELECTRODE (K974515) | Endolap, Inc. | 1997-12-22 |
| SYVEK PATCH (K972914) | Marine Polymer Technologies, Inc. | 1997-12-22 |
| ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM (K972406) | Immunoprobe, Inc. | 1997-12-22 |
| ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER SYRINGE, CLINICALLY ASPIRATOR (K974032) | A & A Medical, Inc. | 1997-12-22 |
| SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY (K974551) | Sealite Sciences, Inc. | 1997-12-22 |
| IMAGEN RESPIRATORY SCREEN (K973954) | Dako Diagnostics , Ltd. | 1997-12-22 |
| ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL (K974423) | Sterling Diagnostic Imaging, Inc. | 1997-12-22 |
| ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM (K973686) | Endocare, Inc. | 1997-12-22 |
| PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE (K974036) | The Prometheus Group | 1997-12-22 |
| SOMNOPLASTY SYSTEM (K973618) | Somnus Medical Technologies, Inc. | 1997-12-19 |
| MIDSTREAM HOME REGNANCY TEST (K973825) | Germaine Laboratories, Inc. | 1997-12-19 |
| RADIAL AND FEMORAL ARTERY CATHETER (K971086) | B.Braun Medical, Inc. | 1997-12-19 |
| PREFERENCE 60 AND PREFERENCE 60 TORIC (K963013) | CooperVision, Inc. | 1997-12-19 |
| SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 1064/532 LASER SYSTEM (K973603) | Schwartz Electro-Optics, Inc. | 1997-12-19 |
| IGN 500 TM WATER CLEANING UNIT WITH CALBENIUM LIQUID (K964271) | Airel-West | 1997-12-19 |
| CLIRANS T-SERIES HOLLOW FIBER DIALYZERS (K970708) | Terumo Medical Corp. | 1997-12-19 |
| NATURAL-HIP COCR OFFSET STEM (K973681) | Sulzer Orthopedics, Inc. | 1997-12-19 |
| KOLPLAST VAGINAL SPECULUM (K973853) | Kolplast Comercial E Industrial Ltda | 1997-12-19 |
| CHOICE ACCU-TEST PREGNANCY TEST KIT (K974154) | Sa Scientific, Inc. | 1997-12-19 |
| PROPHYFLEX 2, MODEL 2012 (K973876) | Kavo America | 1997-12-19 |
| TELEMED SYSTEMS RETRIEVAL BASKET (K974300) | Telemed Systems, Inc. | 1997-12-19 |
| THE POSTERIOR STABILISED NUFFIELD TOTAL KNEE SYSTEM (K973595) | Corin USA | 1997-12-19 |
| CERCLAGE CABLE WITH HEX BUTTON (K974016) | Pioneer Surgical Technology | 1997-12-19 |
| AMSURE CLEANSING ENEMA SET (K974042) | Amsino Intl., Inc. | 1997-12-19 |
| COPAXONE (GLATIRAMER ACETATE FOR INJECTION) EZ-JECT FROM SHARED SOLUTIONS (K974171) | Teva Medical, Ltd. | 1997-12-19 |
| ELECTRODE, ELECTROCARDIOGRAPH (K973727) | Don Tay Industries | 1997-12-19 |
| SIGNAL PREGNANCY TEST KIT (K974021) | Sa Scientific, Inc. | 1997-12-19 |
| HYDRA METER (K974127) | Automata Instrumentation, Inc. | 1997-12-19 |
| SPINAL CONCEPTS, INC., CFIX CABLE SYSTEM (K974020) | Spinal Concepts, Inc. | 1997-12-19 |
| DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES (K973291) | Dynamic Technology Corp. | 1997-12-19 |
| ERBIUM 2000 LASER FAMILY (K972915) | Phantom Technologies, Inc. | 1997-12-19 |
| AURELUX 77 (K972946) | Aurex Precious Metal Industries (Pty)Ltd | 1997-12-19 |
| NATURAL-HIP POROUS STEM WITH OFFSET (K973675) | Sulzer Orthopedics, Inc. | 1997-12-19 |
| QUICKVUE SEMI-Q HCG-COMBO (K974052) | Quidel Corp. | 1997-12-19 |
| MICROPROTEIN STANDARD KIT (K974290) | Verichem Laboratories, Inc. | 1997-12-19 |
| VALLEY FORGE BIPOLAR BALL TIP ELECTRODE (K973554) | Valley Forge Scientific Corp. | 1997-12-19 |
| AESOP 3000 SYSTEM AND ACCESSORIES (K972699) | Computer Motion, Inc. | 1997-12-19 |
| ORTHOFIX FEMORAL NAILING SYTEM (K973944) | Orthofix Srl | 1997-12-19 |
| PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM (K972314) | Diametrics Medical, Ltd. | 1997-12-19 |
| REVELATION POROUS HIP STEM (K973685) | Encore Orthopedics, Inc. | 1997-12-19 |
| AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE (K973893) | Applied Medical Technologies | 1997-12-19 |