| FRAMEWAVE WEB (K983401) | Ml Strategies, Inc. | 1998-12-15 |
| ELECTRON WEDGE MODEL MT-EW-1000 (K981992) | Med-Tec,Inc. | 1998-12-15 |
| FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODEL (K983199) | Fibra Sonics, Inc. | 1998-12-14 |
| MS-900S, MS-900SPM & MS-900SFM (K980845) | Mars Medical Products | 1998-12-14 |
| BARTELS CINAKIT CMV ANTIGENEMIA (K982311) | Intracel Corp. | 1998-12-14 |
| LATEX POWDER FREE EXAMINATION GLOVES (K981942) | Maika Rubber Products Sdn Bhd | 1998-12-14 |
| MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPES (K982694) | Medline Industries, Inc. | 1998-12-14 |
| LIQUICHEK SERUM VOLATILES CONTROL, MODELS 383 AND 384 (K984225) | Bio-Rad | 1998-12-14 |
| STRATUS (R) CS CARDIAC TROPONIN I (TROP) TESTPAK (K984093) | Dade Behring, Inc. | 1998-12-14 |
| DIMENSIONS RXL MYOGLOBIN (MYO) CALIBRATOR (K984193) | Dade Behring, Inc. | 1998-12-14 |
| ESP7 VENOUS IMAGE (K982612) | Ironmaster, Inc. | 1998-12-14 |
| THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE (K983803) | Zeus Scientific, Inc. | 1998-12-14 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN CALIBRATOR (K983340) | Beckman Coulter, Inc. | 1998-12-14 |
| SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACIN (K983309) | Accumed Intl., Inc. | 1998-12-14 |
| ENCORE MARK IV POWDER FREE POLYMER COATED LATEX SURGICAL GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE) (K983489) | Ansell Perry | 1998-12-14 |
| STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK (K984065) | Dade Behring, Inc. | 1998-12-14 |
| RTM DVT PROSOFT CUFF MODEL NUMBER PS100 (K981643) | R.T. Medical Services, Inc. | 1998-12-14 |
| ELECSYS CALCHECK TROPONIN T (K984372) | Boehringer Mannheim Corp. | 1998-12-14 |
| DYNAREX TRACHEOSTOMY SPONGE (K983348) | Dynarex Corp. | 1998-12-11 |
| MAGNETIC RESONANCE DIAGNOSTIC DEVICE, AIRIS II (K984278) | Hitachi Medical Systems America, Inc. | 1998-12-11 |
| SIRONA C8 DENTAL OPERATIVE UNIT WITH ACCESSORIES (K983242) | Sirona Dental Systems GmbH | 1998-12-11 |
| MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES (K983699) | Roche Diagnostic Systems, Inc. | 1998-12-11 |
| POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE (K983729) | Perusahaan Getah Asas Sdn. Bhd. | 1998-12-11 |
| ILO292 DP ECHOPORT PLUS OAE SYSTEM (K983351) | Otodynamics, Ltd. | 1998-12-11 |
| CDR - PAN MODEL 4700 (K982661) | Schick Technologies, Inc. | 1998-12-11 |
| ILO292 DP ECHOPORT PLUS OAE SYSTEM (K983350) | Otodynamics, Ltd. | 1998-12-11 |
| DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION (K980632) | Howmedica Corp. | 1998-12-11 |
| MEROPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K983718) | Oxoid , Ltd. | 1998-12-11 |
| INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX (K983200) | Ximed/Prosure/Injectx | 1998-12-11 |
| SURECAUT DIAMOND LASER KNIFE (K983463) | Clinicon Corp. | 1998-12-11 |
| OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, BLUE (K983730) | Omnigrace , Ltd. | 1998-12-11 |
| FV-RF (K984111) | Philips Medical Systems (Cleveland), Inc. | 1998-12-11 |
| SEARE BIOMEDICAL SILICONE TISSUE EXPANDER (K983792) | Seare Biomedical Corp. | 1998-12-11 |
| OLYMPUS UM 2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT, FOR BRONCHIAL USE (K982323) | Olympus America, Inc. | 1998-12-11 |
| INJECTION NEEDLE PROBE/DEVICE-TUNIS (K983765) | Ximed/Prosure/Injectx | 1998-12-11 |
| MODIFICATION TO PROWESS PRO-SIM (K984196) | Ssgi Prowess Systems | 1998-12-11 |
| AVL OPTI CRITICAL CARE ANALYZER (K984299) | Avl Scientific Corp. | 1998-12-11 |
| XENON LIGHT SOURCE AUTO LIP 5123, MODEL 2123.011 (K983628) | Richard Wolf Medical Instruments Corp. | 1998-12-11 |
| SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT (K983599) | Andwin Scientific | 1998-12-11 |
| COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER (K982651) | Corometrics Medical Systems, Inc. | 1998-12-11 |
| OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM (K983382) | Osteonics Corp. | 1998-12-11 |
| ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY (K983313) | Elscint, Inc. | 1998-12-11 |
| ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK (K983352) | Otodynamics, Ltd. | 1998-12-11 |
| PHILIPS INTURIS CARDIO IMAGE VIEWING PACKAGE (K983821) | Philips Medical Systems North America, Inc. | 1998-12-11 |
| IMMULITE RUBELLA QUANTITATIVE IGG, CATALOG # LKRBQ1 (100 TESTS), LKRBQ5 (500 TESTS) (K982078) | Diagnostic Products Corp. | 1998-12-11 |
| SD-956 ULTRASOUND THERAPY (K981449) | Skylark Device Co., Ltd. | 1998-12-11 |
| ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS (K983320) | Suretex Prophylactics (India) , Ltd. | 1998-12-11 |
| VERTICAL LIFT (K983526) | Barnes,Richardson & Colburn | 1998-12-11 |
| MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL MRP-5000 (K984272) | Hitachi Medical Systems America, Inc. | 1998-12-11 |
| SILVERSTREAK HYDROPHILIC GUIDEWIRE (K982543) | Micro Therapeutics, Inc. | 1998-12-11 |
| SEARE BIOMEDICAL SILICONE RODS (K983630) | Seare Biomedical Corp. | 1998-12-11 |
| STRATA, MODEL V.O.95 (K981678) | Rosses Medical Systems | 1998-12-11 |
| MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS (K983701) | Roche Diagnostic Systems, Inc. | 1998-12-11 |
| POWER BLOCK (K983227) | Kreativ, Inc. | 1998-12-11 |
| DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION (K980626) | Howmedica Corp. | 1998-12-11 |
| MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE (K983697) | Roche Diagnostic Systems, Inc. | 1998-12-11 |
| MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE (K983703) | Roche Diagnostic Systems, Inc. | 1998-12-11 |
| MAX-ACT (K983649) | Array Medical, Inc. | 1998-12-11 |
| ULTRACON ULTRAFILTRATOR (K981253) | Interpore Intl. | 1998-12-11 |
| MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE (K983700) | Roche Diagnostic Systems, Inc. | 1998-12-11 |
| LIGHT DUTY PNEUMATIC INSTRUMENT MODEL NUMBER PAD-100, HEAVY DUTY PNEUMATIC INSTRUMENT MODEL PAD-200, LIGHT DUTY ELECTRI (K981922) | Microaire Surgical Instruments, Inc. | 1998-12-10 |
| NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEM (K984379) | Puritan Bennett Corp. | 1998-12-10 |
| ALGISITE M (K983210) | Smith & Nephew, Inc. | 1998-12-10 |
| ACTICOAT COMPOSITE WOUND DRESSING, ACTICOAT COMPOSITE WOUND DRESSING-ADHESIVE (K983833) | Westaim Biomedical, Inc. | 1998-12-10 |
| ALOE THERAPY ORAL RINSE (K983182) | Carrington Laboratories, Inc. | 1998-12-10 |
| MEDSOL GOLDENBERG BONE MARROW BIOPSY NEEDLE (K983187) | Medsol Corp. | 1998-12-10 |
| THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO (K983801) | Zeus Scientific, Inc. | 1998-12-10 |
| CLEARVIEW IM (K981946) | Unipath , Ltd. | 1998-12-10 |
| INTERSOURCE (K973328) | International Brachytherapy S.A. | 1998-12-10 |
| MEDCOMP H-CATH TRIPLE LUMEN CENTRAL VENOUS ACCESS CATHETER, MODEL SIC 12-3T (K983412) | Medical Components, Inc. | 1998-12-10 |
| MEDTRONIC ANGIOGRAPHIC CATHETER (K980973) | Medtronics Interventional Vascular | 1998-12-10 |
| GORE REVOX THYROPLASTY IMPLANT (K983525) | W. L. Gore & Associates, Inc. | 1998-12-10 |
| GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P (K983183) | Bien Air USA, Inc. | 1998-12-10 |
| ALUMINA-ZINC OXIDE POWDERS F AND R (K983752) | Harry J. Bosworth Co. | 1998-12-10 |
| AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM (K982076) | Amira Medical, Inc. | 1998-12-10 |
| QBC CENTRIFUGAL HEMATOLOGY CONTROL (K984099) | R&D Systems, Inc. | 1998-12-10 |
| MYOGLOBIN FLEX REAGENT CARTRIDGE (K984191) | Dade Behring, Inc. | 1998-12-10 |
| MELODIE INFUSION PUMP (K980378) | Compagnie DE Developpement Aguettant | 1998-12-09 |
| INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND DRESSINGS (K983303) | Innovative Technologies , Ltd. | 1998-12-09 |
| CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 (K984277) | Medical Analysis Systems, Inc. | 1998-12-09 |
| STARTRACK INFANT GRAPHICS MONITOR (K983274) | Nellcor Puritan Bennett, Inc. | 1998-12-09 |
| BATCH #6060 CONDUCTIVE GEL (K983964) | Skylark Device Co., Ltd. | 1998-12-09 |
| K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60 (K981737) | Katecho, Inc. | 1998-12-09 |
| ORCA-DX BONE DENSITOMETER (K983724) | Lunar Corp. | 1998-12-08 |
| CLINICAL ELECTRONIC THERMOMETER (K982140) | Valeo Corp. | 1998-12-08 |
| THE APTUS (AUTOMATED) APPLICATION OF THE EBV-EA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR (K983804) | Zeus Scientific, Inc. | 1998-12-08 |
| PULSED OXYGEN CONSERVING DEVICE, POCD (K983459) | Medical Electronic Devices, Inc. | 1998-12-08 |
| PRODIGY TOTAL BODY SOFTWARE (K983564) | Lunar Corp. | 1998-12-08 |
| ELECSYS TROPONIN T STAT TEST (K984105) | Boehringer Mannheim Corp. | 1998-12-08 |
| CRX DIAMOND VALVE (K974096) | Phoenix Biomedical Corp. | 1998-12-08 |
| BTA STAT TEST PRESCRIPTION HOME USE (K974845) | Bard Diagnostic Sciences,Inc. | 1998-12-08 |
| MAXVIEW DIAGNOSTIC WORKSTATION (K984023) | Dynamic Healthcare Technologies, Inc. | 1998-12-08 |
| MODIFICATION TO WILSON-COOK LUNG BIOPSY NEEDLE (K984157) | Wilson-Cook Medical, Inc. | 1998-12-08 |
| PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE TEST ST (K982303) | Medisense, Inc. | 1998-12-08 |
| CHLORINATED, POLYMER-COATED, POWDER-FREE LATEX EXAMINATION GLOVE (K983723) | Kossan Latex Industries(M)Sdn Bhd | 1998-12-07 |
| BROWNE GA INDICATOR FOR CIDEX PRODUCTS (K981054) | Albert Browne , Ltd. | 1998-12-07 |
| ARSOFT (K983146) | Alliance Rubber Products Sdn. Bhd. | 1998-12-07 |
| SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE (K981665) | Bio-Medical Sciences, Inc. | 1998-12-07 |
| REAADS IGG ANTI-B2GPI TEST KIT (K982391) | Corgenix, Inc. | 1998-12-07 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL RANGE VERIFIERS (K984011) | Ortho-Clinical Diagnostics, Inc. | 1998-12-07 |