| MCD-AC (K971980) | Adac Laboratories | 1997-10-23 |
| BARIAIR (K955243) | Kinetic Concepts, Inc. | 1997-10-23 |
| BANG POLYMER GEL DOSIMETER, BANG 533 (K972804) | Mgs Research, Inc. | 1997-10-23 |
| VIKING DIAGNOSTIC ELECTRODE CATHETER (K971265) | C.R. Bard, Inc. | 1997-10-23 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340) (K973331) | Ortho-Clinical Diagnostics, Inc. | 1997-10-22 |
| TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBES (K970742) | Becton Dickinson Immunocytometry Systems | 1997-10-22 |
| QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL) (K973464) | Instrumentation Laboratory CO | 1997-10-22 |
| MDP2000 MEDICAL DATA PROCESSOR (K972880) | Vidco, Inc. | 1997-10-22 |
| FINALLY FREE (K972695) | Mehl/Group Marketing | 1997-10-22 |
| ROYALE BRAND LATEX CONDOMS-SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS (K972836) | G. Premjee (Usa), Inc. | 1997-10-22 |
| MICROENDOSCOPE(8755.401,411,461,451)/EXTERNAL SHEATH(8755.221,222)/VERESS CANNULA(8755.211,212) (K971420) | Richard Wolf Medical Instruments Corp. | 1997-10-22 |
| AHCS HEMOPERFUSION SYSTEM (K971015) | American Health Care Systems, Inc. | 1997-10-22 |
| LIQUID ALKALINE PHOSHATASE REAGENT SET (K973588) | Pointe Scientific, Inc., | 1997-10-22 |
| WIRELESS LAN (LOCAL AREA NETWORK) - WIRELESS ETHERNET (K971683) | Marquette Electronics, Inc. | 1997-10-22 |
| TOXOPLASMA IGM ASSAY FOR THE BAYER IMMUNO1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K971989) | Bayer Corp. | 1997-10-22 |
| TRANSPARENT FILM DRESSING, INTELLIGENT FILM DRESSING (K973312) | Innovative Technologies , Ltd. | 1997-10-22 |
| LINK, ACETABULAR REVISION MESH CUP (K972760) | Link America, Inc. | 1997-10-22 |
| AUTO-LYTE COTININE EIA (K972481) | OraSure Technologies, Inc. | 1997-10-21 |
| KELOCOTE SCAR GEL AND KELOCOTE LASER GEL (K973572) | Hanson Medical, Inc. | 1997-10-21 |
| HYDRASORB STERILE DRESSING (K973260) | Avitar, Inc. | 1997-10-21 |
| NIHON KOHDEN TEC-7511A/TEC-7521A CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES (K971436) | Nihon Kohden America, Inc. | 1997-10-21 |
| CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH) (K971897) | Medron, Inc. | 1997-10-21 |
| LUDLOW TECHNICAL PRODUCTS, ELECTRODE, ELECTROSURGICAL, DISPOSABLE PEDIATRIC DISPERSIVE ELECTRODES; WITH AND WITHOUT CORD (K973110) | Ludlow Technical Products | 1997-10-21 |
| ALLIANCE RUBBER, EC-GRIP (K972801) | Alliance Rubber Products Sdn. Bhd. | 1997-10-21 |
| VISTA BRITE TIP GUIDING CATHETERS (K972978) | Cordis Corp. | 1997-10-21 |
| TITANIUM HEMOSTATIC CLIP (K972745) | Eisner USA, Inc. | 1997-10-21 |
| ADVANCE ULTRA-CONGRUENT TIBIAL INSERT (K972770) | Wrightmedicaltechnologyinc | 1997-10-21 |
| POWDER-FREE LATEX EXAMINATION GLOVE, TEAL OR WHITE (NON-COLORED) (K973811) | Absolute Quality Leadership, Inc. | 1997-10-21 |
| SERAQUEST TOXOPLASMA IGM (K971672) | Quest Intl., Inc. | 1997-10-21 |
| NUVOLASE 720 SYSTEM FOR OPHTHALMOLOGY LASER (K972765) | American Laser Medical | 1997-10-21 |
| DENTALVIEW PERIOVIEW SYSTEM (K973492) | Dentalview, Inc. | 1997-10-21 |
| ALGINATE/ZINC WOUND DRESSING (K973283) | Innovative Technologies , Ltd. | 1997-10-21 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP6/100 (K972746) | Alexander Mfg. Co. | 1997-10-21 |
| NPB-290 PULSE OXIMETER (NPB-290) (K972837) | Nellcor Puritan Bennett, Inc. | 1997-10-21 |
| HYDROFLEX (K973343) | GC America, Inc. | 1997-10-21 |
| REGENESIS MODEL 42 (K972093) | Regenesis Biomedical, Inc. | 1997-10-21 |
| PROVISION SURGICAL HELMET SYSTEM (K972832) | Depuy, Inc. | 1997-10-21 |
| DURACON CONVERSION METAL BACKED PATELLA (K972752) | Howmedica Corp. | 1997-10-21 |
| HISTOFREEZER VERRUCA PLANA (K971392) | OraSure Technologies, Inc. | 1997-10-21 |
| DIGIFLEX SURGICAL GLOVES (K972277) | Hms Services, Inc. | 1997-10-21 |
| FEMASSIST URINARY DEVICE (K963858) | Insight Medical Corp. | 1997-10-21 |
| BOVIE MODEL X40 (K972071) | Maxxim Medical | 1997-10-21 |
| ISLAND BIOSURGICAL INC. BNS KIT #1 & #2 (K973022) | Island Biosurgical, Inc. | 1997-10-20 |
| N-ASSAY TIA ANTITHROMBIN III TEST KIT (K972257) | Crestat Diagnostics, Inc. | 1997-10-20 |
| FIRST SIGN (K973208) | Texas Immunology, Inc. | 1997-10-20 |
| QUANTA LITE B2GPI IGM (K973014) | Inova Diagnostics, Inc. | 1997-10-20 |
| ULTRASOUND TRANSDUCER DRAPE (K970889) | Protek Medical Products, Inc. | 1997-10-20 |
| REXAM FRACTURE RESISTANT POUCH (K973440) | Rexam Medical Packaging, Inc. | 1997-10-20 |
| ANEUVYSION (K972200) | Vysis | 1997-10-20 |
| CS-400 COAGULATION ANALYZER SYSTEM (A1208) (K972260) | Sigma Diagnostics, Inc. | 1997-10-20 |
| TROPONIN (TROP) METHOD (K973650) | Dade Chemistry Systems, Inc. | 1997-10-20 |
| I-STAT SYSTEM (K973292) | I-Stat Corp. | 1997-10-20 |
| ULTRASOUND TRANSDUCER DRAPE (K970893) | Protek Medical Products, Inc. | 1997-10-20 |
| VENTANA CD45 PRIMARY ANTIBODY (K940583) | Ventana Medical Systems, Inc. | 1997-10-20 |
| HEMAPROMPT (K972763) | Aerscher Diagnostics | 1997-10-20 |
| N ANTISERUM TO HUMAN ALBUMIN (K972929) | Behring Diagnostics, Inc. | 1997-10-20 |
| QUANTA LITE B2 GPI IGA (K973006) | Inova Diagnostics, Inc. | 1997-10-20 |
| N-ASSAY TIA PLASMINOGEN TEST KIT (K971985) | Crestat Diagnostics, Inc. | 1997-10-20 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS3030-P (K972779) | Alexander Mfg. Co. | 1997-10-20 |
| DBEST REAGENT STRIP FOR URINALYSIS (K973142) | Ameritek, Inc. | 1997-10-20 |
| ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS (K973535) | Schiapparelli Biosystems, Inc. | 1997-10-20 |
| CARDIAC TROPONIN-I (TROP) CALIBRATOR (K973668) | Dade Intl., Inc. | 1997-10-20 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625 (K972780) | Alexander Mfg. Co. | 1997-10-20 |
| N ANTISERUM TO HUMAN TRANSFERRIN (K972840) | Behring Diagnostics, Inc. | 1997-10-17 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL600-0016 (K972789) | Alexander Mfg. Co. | 1997-10-17 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL9366 (K972786) | Alexander Mfg. Co. | 1997-10-17 |
| STRAIT'MAP OPTION (K973368) | Ge Medical Systems, Inc. | 1997-10-17 |
| DONG BANG ACUPUNCTURE NEEDLES (K972659) | Dong Bang, U.S.A. | 1997-10-17 |
| D72 DIGITAL (K972818) | Philips Hearing Instruments Co. | 1997-10-17 |
| SIEMENS MULTIVIEW WORKSTATION INFINITY TELEMETRY SYSTEM (K972714) | Siemens Medical Solutions USA, Inc. | 1997-10-17 |
| MAGI ACUPUNCTURE NEEDLES (K972658) | Dong Bang, U.S.A. | 1997-10-17 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M850-P (K972787) | Alexander Mfg. Co. | 1997-10-17 |
| SOFT TIP EPIDURAL CATHETER KIT (K971233) | B.Braun Medical, Inc. | 1997-10-17 |
| ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERS (K970864) | Arrow Intl., Inc. | 1997-10-17 |
| BARD RAPIDFIRE MULTIPLE BAND LIGATOR (K971137) | C.R. Bard, Inc. | 1997-10-16 |
| HARMAC BALLOON WEDGE PRESSURE CATHETER (K963335) | Harmac Medical Products, Inc. | 1997-10-16 |
| BARD ENDOSCOPIC OVERTUBE (#000307) (K973500) | C.R. Bard, Inc. | 1997-10-16 |
| DURATION STABILIZED UHMWPE ACETABULAR COMPONENTS (K972792) | Howmedica Corp. | 1997-10-16 |
| VINTAGE HALO (K973247) | Shofu Dental Corp. | 1997-10-16 |
| DRTS REMOTE CONTROL DRAPE (K973067) | Minrad, Inc. | 1997-10-16 |
| VERABOND 2V (K973265) | Aalba Dent, Inc. | 1997-10-16 |
| POWERHEART AECD (K970741) | Cardiac Science, Inc. | 1997-10-16 |
| REJOYN PENILE SUPPORT SYSTEM (K971576) | American Medtech | 1997-10-16 |
| HARMAC BALLOON ANGIOGRAPHIC CATHETER (K962829) | Harmac Medical Products, Inc. | 1997-10-16 |
| SUNGLASSES (K973526) | Pyramid Handbags, Inc. | 1997-10-16 |
| SYNTHES SPINE SMALL STATURE ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM (K971883) | Synthes (Usa) | 1997-10-16 |
| SYNTHES COMBINATION CLAMP AND DYNAMIZATION CLIP (K973017) | Synthes (Usa) | 1997-10-16 |
| MOA BONE / M-SPHERE (K972143) | Iop, Inc. | 1997-10-16 |
| INFINTY DISTAL FEMORAL COMPONENT (K973530) | Wrightmedicaltechnologyinc | 1997-10-16 |
| BRANEMARK SYSTEM ZYGOMATICUS FIXTURE SYSTEM (K970499) | Nobel Biocare Uas, Inc. | 1997-10-16 |
| TBI STAND (K972709) | Mick Radio-Nuclear Instruments, Inc. | 1997-10-16 |
| LEGACY/LEGACY-D TABLE (K973039) | GE Medical Systems | 1997-10-16 |
| VARI-ANGLE HIP SCREW (VHS) SYSTEM (K964880) | Walter Abendschein, M.D. | 1997-10-16 |
| IMAGEVIEW CORONARY ANGIOGRAPHY DISPLAY AND REVIEW SYSTEM (K972229) | Heartware, Inc. | 1997-10-16 |
| QUIX RAPID E. COLI O157 STRIP TEST (K972156) | Guardian Scientific, Corp. | 1997-10-16 |
| CD SPINAL SYSTEM (K964159) | Sofamor Danek USA,Inc. | 1997-10-16 |
| HARMAC TEMPORARY PACING CATHETER WITH BALLOON (K962833) | Harmac Medical Products, Inc. | 1997-10-15 |
| ULTRAFAST CT SCANNER; EBT CT SCANNER, EVOLUTION (K972879) | Imatron, Inc. | 1997-10-15 |
| ZIRCONIA CERAMIC FEMORAL HEAD (K972690) | Zimmer, Inc. | 1997-10-15 |
| ABC TOTAL ELBOW PROTHESIS (K972691) | Biomet, Inc. | 1997-10-15 |