| ELECTROCARDIOGRAPHS (K972587) | Dr. Lee Co., Ltd. | 1998-08-21 |
| ULTRA IMAGE AND ULTRA SCAN (K981028) | Sonotech, Inc. | 1998-08-21 |
| ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA (K981120) | Zeus Scientific, Inc. | 1998-08-21 |
| ULTIMA BODY POSITION SENSOR (K981969) | Braebon Medical Corp. | 1998-08-20 |
| THERMATREK IRIS-3 INFRARED IMAGING SYSTEM (K982112) | Thermatrek, Inc. | 1998-08-20 |
| MODIFICATION OF AUTOTRANSFUSION APPARATUS (AUTOLOG) (K982755) | Medtronic Blood Management | 1998-08-20 |
| PLAQ-ATAQ-I (K980995) | Ethicare | 1998-08-20 |
| INTEGRATED DRIVE/PUMP SYSTEM (K981636) | Linvatec Corp. | 1998-08-20 |
| AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR (K981939) | Bci Intl., Inc. | 1998-08-20 |
| VISAGE COSMETIC SURGERY SYSTEM (K981870) | Arthrocare Corp. | 1998-08-20 |
| URETHROPEXY SUTURE PLACEMENT KIT MODEL NUMBERS UM-300, MW-100, MINI-LAPAROTOMY MMK KIT MODEL UM-250, LAPAROSCOPIC BURCH0 (K982626) | Medworks Corp. | 1998-08-20 |
| SABRATEK PATIENT HOME MANAGEMENT SYSTEM (K980619) | Sabratek Corp. | 1998-08-20 |
| PTA BALLOON CATHETER (K980390) | Cook, Inc. | 1998-08-20 |
| FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE (K982597) | Johnson & Johnson Medical, Inc. | 1998-08-20 |
| BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX (K981747) | Sunscope Intl., Inc. | 1998-08-20 |
| NPB3900 SERIES PATIENT MONITORS (K980411) | Analogic Corp. | 1998-08-20 |
| CARDIOVISION SOFTWARE, MODEL S-CV5-96 (K981807) | Shl Telemedicine International , Ltd. | 1998-08-19 |
| FUTREX-6100/XL (K963271) | Futrex, Inc. | 1998-08-19 |
| HICHEM CHOLESTEROL REAGENT KIT (K982469) | Elan Pharma, Inc. | 1998-08-19 |
| SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT (K982608) | Sangui Biotech, Inc. | 1998-08-19 |
| KSEA ENDO TIP SYSTEM (K981130) | KARL STORZ Endoscopy-America, Inc. | 1998-08-19 |
| HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120## (K982289) | Olympus America, Inc. | 1998-08-19 |
| PLATEX GENTLE GLIDE, SILK GLIDE, SLIMFITS, SOFT COMFORT AND PORTABLES TAMPONS (K982383) | Playtex Products, Inc. | 1998-08-19 |
| SIEMENS SEVOFLURANE VAPORIZER SV 953 (K980884) | Siemens Medical Solutions USA, Inc. | 1998-08-19 |
| SYNTHES (USA) [SYNTHES] MMFS - 2.0 MM SAGITTAL SPLIT PLATES (K981890) | Synthes (Usa) | 1998-08-18 |
| QUICK & SURE ONESTEP HOME PREGNANCY TEST (K981892) | Abacus Diagnostics | 1998-08-18 |
| CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE (K981962) | Cuda Products Co. | 1998-08-18 |
| CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 (K980588) | Clarus Medical Systems, Inc. | 1998-08-18 |
| APOLLO 95E (K981948) | Dental/Medical Diagnostic Systems, Inc. | 1998-08-18 |
| 6F ENVOY GUIDING CATHETER (K982770) | Cordis Corp. | 1998-08-18 |
| OLYMPUS SERUM PROTEIN MULTICALIBRATOR, (K981854) | Olympus Diagnostica GmbH | 1998-08-18 |
| DYTRACT FLOW RESTORATIVE (K982395) | Dentsply Intl. | 1998-08-18 |
| MB/BACT BLOOD CULTURE BOTTLE (K982263) | Organon Teknika Corp. | 1998-08-18 |
| VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS (K981953) | Paragon Trade Brands, Inc. | 1998-08-18 |
| CT CORONARY ARTERY CALCIFICATION SCORING (CACS) OPTION FOR ADVANTAGE WINDOWS (K982004) | General Electric Co. | 1998-08-18 |
| SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER (K981788) | Scimed Life Systems, Inc. | 1998-08-18 |
| ROCHE C0BAS INTEGRA SERUM BARBITURATES REAGENT CASSETTE, ABUSCREEB ONLINE SERUM BARBITURATES CALIBRATORS, ROCHE COBAS IN (K982551) | Roche Diagnostic Systems, Inc. | 1998-08-18 |
| OPC LOWWEAR PORCELAIN (K982377) | Jeneric/Pentron, Inc. | 1998-08-18 |
| INFRAMETRICS INFRACAM-MED (K982327) | Inframetrics, Inc. | 1998-08-18 |
| STERILE SALINE SOLUTION 0.9%- CATALOG NO, 10290, STERILE WATER- CATALOG NO. 10291 (K981905) | Acu-Pak | 1998-08-18 |
| ROCHE CRP T CONTROL N (K982087) | Roche Diagnostic Systems, Inc. | 1998-08-18 |
| SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT (K982251) | Sigma Diagnostics, Inc. | 1998-08-18 |
| PARENCHYMAL BOLT PRESSURE MONITORING KIT (K981846) | Camino Neurocare, Inc. | 1998-08-18 |
| ENVOY AND VISTA BRITE TIP (K982632) | Cordis Corp. | 1998-08-18 |
| DPX-RX BONE DENSITOMETER (K982267) | Lunar Corp. | 1998-08-18 |
| CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER (K980109) | Sangstat Medical Corp. | 1998-08-18 |
| POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (K980916) | Perusahaan Getah Asas Sdn. Bhd. | 1998-08-18 |
| SOLUTION ADMINISTRATION SET (K981792) | Baxter Healthcare Corp | 1998-08-17 |
| A.M.T. G-TUBE BALLOON REPLACEMENT GASTROSTOMY FEEDING DEVICE (K971434) | Applied Medical Technologies | 1998-08-17 |
| 3I ORTHODONTIC ABUTMENT, ORTHOBUTMENT (K980083) | Implant Innovations, Inc. | 1998-08-17 |
| DINAMAP MPS SELECT PORTABLE MONITOR (K982342) | Critikon Company, LLC | 1998-08-14 |
| SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER (K981761) | Sysmex Corp. | 1998-08-14 |
| NOSEBLEED NOSECLIP (K981966) | Michael M. Knott, M.D. | 1998-08-14 |
| DISCAM DIGITAL IMAGING SYSTEM (K974535) | Marcher Enterprises, Ltd. | 1998-08-14 |
| CAROLINE GUIDE (K981809) | Surgical Solutions, Inc. | 1998-08-14 |
| FLAPMAKER DISPOSABLE MICROKERATOME (K981155) | Hawken Industries | 1998-08-14 |
| ASTHMA MONITOR AM2 (K980876) | Erich Jaeger GmbH & Co. KG | 1998-08-14 |
| CIRCUIT GUARD (K982239) | Arc Medical, Inc. | 1998-08-14 |
| GB-1002 TENS WITH MASSAGE (K964437) | Skylark Device Co., Ltd. | 1998-08-14 |
| BC 900 SLIT LAMP (K982057) | Haag-Streit AG | 1998-08-14 |
| PYRILINKS-D ASSAY KIT (K981364) | Metra Biosystems, Inc. | 1998-08-13 |
| GLYCACOR (K980888) | Exocell, Inc. | 1998-08-13 |
| CLEARSTAR ENTERAL NUTRITION PUMP (K981541) | Frantz Medical Development, Ltd. | 1998-08-13 |
| BI-DENT (K982229) | Valley Forge Scientific Corp. | 1998-08-13 |
| PREALBUMIN CALIBRATOR (K982292) | Dade Behring, Inc. | 1998-08-13 |
| DUREX COLORS AND SCENTS (K980174) | London Intl., LLC | 1998-08-13 |
| SINUSCOPE AND ACCESSORIES (K981751) | Henke Sass Wolf of America, Inc. | 1998-08-13 |
| EL-ANA PROFILES: EL-ENA/4 (K982150) | Theratest Laboratories, Inc. | 1998-08-13 |
| BW-1 (CODE NAME RD-0807) (K981244) | J.F. Jelenko & Co., Inc. | 1998-08-13 |
| JELFINE-52 (CODE NAME RD-0901) (K981257) | J.F. Jelenko & Co., Inc. | 1998-08-13 |
| EL-ANA PROFILES: EL-ENA/5 (K982622) | Theratest Laboratories, Inc. | 1998-08-13 |
| STERILE SILICONE EXTERNAL WOUND COVER (K982065) | Specialty Surgical Products, Inc. | 1998-08-12 |
| TUMOR MARKER CONTROL (K982473) | Diagnostic Products Corp. | 1998-08-12 |
| IMMULITE PSA CONTROL MODULE, MODEL LPSCM (K982637) | Diagnostic Products Corp. | 1998-08-12 |
| ACS:CENTAUR PSA2 IMMUNOASSAY (K981839) | Chiron Diagnostics Corp. | 1998-08-12 |
| MODIFICATION TO ENSEMBLE CENTRAL STATION MONITOR (K982697) | Mennen Medical, Inc. | 1998-08-12 |
| ANS 2000 ECG MONITOR AND RESPIRATION PACER (K973426) | D. E. Hokanson, Inc. | 1998-08-12 |
| MARKWELL GAUZE SPONGE (K982260) | Markwell Intl., Inc. | 1998-08-12 |
| HP ANESTHESIA GAS MONITOR (WATERTRAP), MODEL A02 (K982619) | Hewlett-Packard Co. | 1998-08-12 |
| D903 AVANT ADULT HOLLOW FIBER OXYGENATOR (K980600) | Dideco S.P.A. | 1998-08-12 |
| BETTER-BLADDER (BB) (K981284) | Circulatory Technology, Inc. | 1998-08-12 |
| VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, AND III (K982649) | Ortho-Clinical Diagnostics, Inc. | 1998-08-12 |
| SIEMENS SC9000/SC9015 TCP02/C02 MODULE (K980287) | Siemens Medical Solutions USA, Inc. | 1998-08-12 |
| MICROALBUSTIX REAGENT STRIPS (K982219) | Bayer Corp. | 1998-08-12 |
| LOW PROFILE PORT ATTACHABLE CATHETER WITH BLUE FLEX TIP / 8FR. INRODUCER KIT IMPLANTABLE VASCULAR ACCESS SYSTEM (K981782) | Arrow Intl., Inc. | 1998-08-12 |
| ACS:CENTAUR CEA (K981478) | Chiron Diagnostics Corp. | 1998-08-12 |
| KSEA UNIMAT 45 (K981703) | Karl Storz Endoscopy | 1998-08-12 |
| DEROYAL INDUSTRIES, INC. DEFOGGER (K982465) | Deroyal Industries, Inc. | 1998-08-11 |
| NITRILE POWDERFREE EXAMINATION GLOVES (K981877) | Besglove Medicare Sdn. Bhd. | 1998-08-11 |
| BREATHAID TONGUE SCRAPER (K981808) | Breathaid, LLC | 1998-08-11 |
| SCC-23 SAFETY CLAMP AND CUTTER (K982464) | Women First Healthcare, Inc. | 1998-08-11 |
| LATEX EXAMINATION GLOVES POWDER FREE (K982579) | Shiva Medicare , Ltd. | 1998-08-11 |
| POWDERED NITRILE EXAMINATION GLOVES (K981879) | Besglove Medicare Sdn. Bhd. | 1998-08-11 |
| POWDERFREE NITRILE EXAMINATION GLOVES (POLYMER COATED) (K981878) | Besglove Medicare Sdn. Bhd. | 1998-08-11 |
| BIOMET 100% POROUS COATED BIAXIAL TOTAL ELBOW (K982398) | Biomet, Inc. | 1998-08-11 |
| OPERATING ROOM TOWELS (K981823) | Baldur Systems Corp. | 1998-08-11 |
| RETROGRADE PEDIATRIC NAIL (K980854) | Encore Orthopedics, Inc. | 1998-08-11 |
| SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS (K980453) | Boston Scientific Scimed, Inc. | 1998-08-11 |
| BONETRAP (K980049) | Bladhs Plast AB | 1998-08-11 |
| PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) (K981681) | Gambro Healthcare | 1998-08-11 |