| PARACENTESIS CATHETER DEVICE (K974146) | Allegiance Healthcare Corp. | 1998-01-28 |
| NON-PRESCRIPTION SUNGLASSES (K974861) | Wenzhou Hindar Optical Co., Ltd. | 1998-01-27 |
| N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000 (K973037) | Avid N.I.T., Inc. | 1998-01-27 |
| BREEZY SERIES (K974820) | Sunrise Medical, Inc. | 1998-01-27 |
| VIROTROL III (K974613) | Blackhawk Biosystems, Inc. | 1998-01-27 |
| CD-R STATION AND VRS-2000 (K974255) | Electromed Intl., Ltd. | 1998-01-27 |
| RINOFLOW MICRONIZED E.N.T. WASH SYSTEM (K973875) | Respironics, Inc. | 1998-01-26 |
| PYRILINKS-D ASSAY KIT (K974260) | Metra Biosystems, Inc. | 1998-01-26 |
| PERIO CONTROL II (K972642) | Estrad B.V. | 1998-01-26 |
| BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL (K974733) | Boehringer Mannheim Corp. | 1998-01-26 |
| HYDROBRUSH (TM) KERATOME (K971078) | Medjet, Inc. | 1998-01-23 |
| WOUND DRAINAGE HOLDER (K973183) | R & D Medical Products, Inc. | 1998-01-23 |
| EXMOOR TYMPANOCENTESIS KIT (TK/1) (K973587) | Exmoor Plastics , Ltd. | 1998-01-23 |
| WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET (K974118) | Worldwide Medical Technologies, LLC | 1998-01-23 |
| ELCOMED 100 TYPES 9925 (W&H- AND INNOVA-VERSION) AND 9927 (ASTRA-VERSION), ELCOMED 200 TYPE 9926 (W&H-VERSION) (K972889) | W & H Dentalwerk | 1998-01-22 |
| AVL OPTI-CHECK PH/ BLOOD GAS/ ELECTROLYTE/THB/ SO2 CONTROL (K974822) | Avl Scientific Corp. | 1998-01-22 |
| BM PRECIPATH(R) HDL/LDL-C CONTROL (K974826) | Boehringer Mannheim Corp. | 1998-01-22 |
| GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90 (K972576) | Accumed Intl., Inc. | 1998-01-22 |
| KODAK DIGITAL SCIENCE QUALITY CONTROL WORKSTATION (QCW) (K974107) | Eastman Kodak Company | 1998-01-21 |
| MILTRA IMAGING INC., IMAGE VAULT (K974102) | Mitra Imaging, Inc. | 1998-01-20 |
| ARGOSY PROGRAMMABLE ONQUE (K974242) | Argosy Electronics | 1998-01-20 |
| KERATOME SYSTEM (K974243) | Insight Technologies Instruments, LLC | 1998-01-20 |
| PDI STERILE LUBRICATING JELLY (K974768) | Nice-Pak Products, Inc. | 1998-01-16 |
| POWDER FREE PATIENT EXAMINATION GLOVE SAFE GLOVE (K973830) | Safe Glove , Ltd. | 1998-01-16 |
| PRIMED SHOE COVERS, PRIMED HEAD COVERS (K971076) | Primeline Medical Products, Inc. | 1998-01-13 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS (K974644) | Johnson & Johnson Clinical Diagnostics, Inc. | 1998-01-13 |
| TRIAGE STATMETER (K973547) | Biosite Incorporated | 1998-01-13 |
| GERMICIDAL CLOTH (K974304) | Convatec, A Division of E.R. Squibb & Sons | 1998-01-13 |
| SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM (K973880) | Sonix Technologies, Inc. | 1998-01-12 |
| SUNGLASSES (K974511) | Sun World Intl., Inc. | 1998-01-12 |
| ESSENTIAL SHAVER SYSTEM (K974232) | Gyrus Ent LLC | 1998-01-12 |
| RANDOX INORGANIC PHOSPHOROUS (K974605) | Randox Laboratories, Ltd. | 1998-01-09 |
| TINA-QUANT PREALBUMIN (K972638) | Boehringer Mannheim Corp. | 1998-01-09 |
| DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES (K974334) | Hong Huang Tang Industrial Co., Ltd. | 1998-01-09 |
| WINGED NEEDLE HOLDER (K974327) | Phx Technologies Corp. | 1998-01-09 |
| SUNGLASSES (K974441) | Hip Shing Fat Co., Ltd. | 1998-01-09 |
| BACTEC MYCO/F LYTIC CULTURE VIALS (K970512) | Becton Dickinson Microbiology Systems | 1998-01-08 |
| TRIAGE(R) CARDIAC PANEL CALIBRATION VERIFICATION CONTROLS, TRIAG (R) MYOGLOBIN CALIBRATION VERIFICATION CONTROLS, TRIAGE (K974827) | Biosite Incorporated | 1998-01-08 |
| MANAN ACCURA NEEDLE (K974741) | Medical Device Technologies, Inc. | 1998-01-08 |
| VISTACAM OMNI AND VIASTCAM OMNI (IC) (K974204) | Air Techniques, Inc. | 1998-01-08 |
| AUTOMATED DISPOSABLE KERATOME (ADK) (K974004) | Lasersight Technologies, Inc. | 1998-01-08 |
| OVULON MONITOR (K973860) | Conception Technology, Inc. | 1998-01-07 |
| TRACE REAGENT LINE FOR THE COBAS MIRA (K973869) | Trace America, Inc. | 1998-01-07 |
| POWDER FREE HYPROALLERGENIC EXAMINATION GLOVE (WITH LOW PROTEIN CLAIM) (K974065) | Tillotson Healthcare Corp. | 1998-01-06 |
| RANDOX IRON (K974604) | Randox Laboratories, Ltd. | 1998-01-06 |
| PRE-POWDERED PATIENT EXAMINATION GLOVE (K973831) | Safe Glove , Ltd. | 1998-01-06 |
| SHENG HO (K964819) | Shang HO Industrial Corp. , Ltd. | 1998-01-06 |
| REP CHOLESTEROL PROFILE CONTROL-II (K974609) | Helena Laboratories | 1998-01-06 |
| PATIENT EXAMINATION POWDER-FREE GLOVES (K973020) | Wear Safe Malaysia Sdn. Bhd. | 1998-01-06 |
| POWDER FREE NITRILE EXAMINATION GLOVES - POLYMER COATED (K974443) | P.T. Latexindo Tobaperkasa | 1998-01-05 |
| IMAGEACCESS SYSTEM (K973805) | Storcomm, Inc. | 1998-01-02 |
| BARCO MWD 321 MEDICAL WORKSTATION DISPLAY (K972701) | Barco NV Display Systems | 1998-01-02 |
| AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) (K974620) | Trace America, Inc. | 1998-01-02 |
| CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800 (K973457) | Shared Systems, Inc. | 1998-01-02 |
| NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDE (K973786) | Nw Radiation Therapy Products | 1998-01-02 |
| WELLCOLEX E.COLI O157:H7 (K971663) | Murex Biotech , Ltd. | 1997-12-30 |
| AESCULAP HILAN MOTOR SYSTEM (K973736) | Aesculap, Inc. | 1997-12-29 |
| HI-CARE CLOSED SUCTION SYSTEM (K972258) | Mallinckrodt Medical | 1997-12-29 |
| EVERGREEN NON-STERILE POWDERED LATEX EXAMINATION GLOVE (K974191) | Yty Industry (Manjung) Sdn Bhd | 1997-12-24 |
| SYSCOS IDC - G, IDC, BSC, IDC - G (K974262) | Scantibodies Laboratory, Inc. | 1997-12-24 |
| N.I.T., INC. NEEDLE GUIDING TEMPLATE (K973638) | Avid N.I.T., Inc. | 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 |
| RDI HOMOGENEOUS HDL CHOLESTEROL TEST (K973988) | Reference Diagnostics, 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 |
| 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 |
| IGN 500 TM WATER CLEANING UNIT WITH CALBENIUM LIQUID (K964271) | Airel-West | 1997-12-19 |
| PROPHYFLEX 2, MODEL 2012 (K973876) | Kavo America | 1997-12-19 |
| AMSURE CLEANSING ENEMA SET (K974042) | Amsino Intl., Inc. | 1997-12-19 |
| COBAS INTEGRA HDL-CHOLESTEROL DIRECT (K973284) | Roche Diagnostic Systems, Inc. | 1997-12-18 |
| POLYMER NITRILE EXAMINATION GLOVES (K974185) | Sri Johani Sdn. Bhd. | 1997-12-18 |
| DERMACLEAN STERILE (PROTEIN LABELING CLAIM) EXAM GLOVES (K974218) | Ansell Perry | 1997-12-18 |
| MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE (K973913) | Pwa Industries Sdn. Bhd. | 1997-12-18 |
| POLYMER NITRILE EXAMINATION GLOVES (BLUE COLOUR) (K974183) | Sri Johani Sdn. Bhd. | 1997-12-18 |
| DASH, VITAL GARD (K974114) | Dash Medical Gloves Sdn Bhd | 1997-12-18 |
| BOUSER'S URINAL (K970465) | General Polymers | 1997-12-18 |
| VINYL PATIENT EXAMINATION GLOVES (POWDERED) (K974151) | Shanghai Super Gloves Co., Ltd. | 1997-12-18 |
| NITRILE, POWDER FREE, POLY COATED PATIENT EXAMINATION GLOVES (K974223) | Derlin Company , Ltd. | 1997-12-18 |
| SHANG HO (K970795) | Shang HO Industrial Corp. , Ltd. | 1997-12-18 |
| HIGH RISK POLYMER LATEX EXAMINATION GLOVES (BLUE COLOUR) (K974184) | Sri Johani Sdn. Bhd. | 1997-12-18 |
| POWDERED NITRILE EXAMINATION GLOVES (BLUE COLOUR) (K974182) | Sri Johani Sdn. Bhd. | 1997-12-17 |
| POWDERFREE NITRILE EXAMINATION GLOVES (BLUE COLOUR) (K973903) | Sri Johani Sdn. Bhd. | 1997-12-17 |
| LACTEST I (K971944) | Jwt, Inc. | 1997-12-17 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K974120) | Shanghai Super Gloves Co., Ltd. | 1997-12-17 |
| MPORT FOLDABLE LENS PLACEMENT SYSTEM (K970727) | Chiron Vision Corp. | 1997-12-17 |
| ULTRACELL SUCTION SPONGE (K972634) | Ultracell Medical Technologies, Inc. | 1997-12-17 |
| PRE-VIEW CHOLANGIOGRAPHY CLAMP (K973621) | Nashville Surgical Instruments | 1997-12-17 |
| POLYMER LATEX EXAMINATION GLOVES (K973904) | Sri Johani Sdn. Bhd. | 1997-12-17 |
| ELITE LIGHTWEIGHT WHEELCHAIR (K974197) | Jaken Co., Inc. | 1997-12-17 |
| DAPELLE HAIR REMOVER (K973773) | Wellquest Intl., Inc. | 1997-12-17 |
| SUPERSKIN (K972081) | Medlogic Global Corp. | 1997-12-17 |
| OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE (K973793) | Olicon Imaging Systems, Inc. | 1997-12-17 |
| VIGIL LIPID CONTROL (K974452) | Beckman Instruments, Inc. | 1997-12-17 |
| PRESTIGE AQUEOUS GLUCOSE CONTROL LOW, PRESTIGE AQUEOUS GLUCOSE CONTROL HIGH (K973676) | Sorrento Biochemical, Inc. | 1997-12-16 |
| ULTRALON POWDER FREE LATEX SURGICAL GLOVE (K973699) | Johnson & Johnson Medical, Inc. | 1997-12-16 |
| ABCA-NT GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEM (K974322) | Europa Scientific, Ltd. | 1997-12-16 |
| ULTRA + AQUEOUS GLUCLOSE CONTROL LOW ULTRA + AQUEOUS GLUCOSE CONTROL HIGH (K973678) | Sorrento Biochemical, Inc. | 1997-12-15 |
| OPUS 2 - CANAL SERIES (ITC) (K974069) | Bernafon-Maico, Inc. | 1997-12-15 |