| ONTRAK TESTCUP AND TESTSTIK CONTROLS (K983387) | Roche Diagnostic Systems, Inc. | 1998-10-09 |
| ULTRACAM (K973410) | W. Edward Johansen | 1998-10-08 |
| MILLENNIUM (K980585) | Biolase Technology, Inc. | 1998-10-08 |
| HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207 (K974854) | Morax | 1998-10-07 |
| HEALTH CHECK URI-TEST PROTEIN IN URINE (K972960) | Tcpi, Inc. | 1998-10-07 |
| URISCREEN (K981084) | Diatech Diagnostics,Inc. | 1998-10-07 |
| QUICKIE SUSPENSION WHEELCHAIR SERIES MODEL XTR (K982989) | Sunrise Medical, Inc. | 1998-10-05 |
| MOMENTUM NO. FS008 WHEELCHAIR (K982099) | Sriram Enterprises D.B.A. Momentum Group | 1998-10-05 |
| PANTHER WHEELCHAIR (K982849) | Snug Seat, Inc. | 1998-10-05 |
| CHOLESTRON PRO II CHOLESTEROL TEST (K981345) | Lifestream Diagnostics, Inc. | 1998-10-01 |
| COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT (K982848) | Roche Diagnostic Systems, Inc. | 1998-10-01 |
| KURER CROWN SAVER K4 ANCHOR SYSTEM-THE UNIVERSAL KIT, KURER STANDARD K4 ANCHOR SYSTEM- THE READY CORE KIT, KURER FIN-LOC (K983161) | Sabre-K , Ltd. | 1998-09-30 |
| CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE (K982806) | Perusahaan Getah Asas Sdn. Bhd. | 1998-09-30 |
| NITRILE PATIENT EXAMINATION GLOVE (K982440) | Perusahaan Getah Asas Sdn. Bhd. | 1998-09-30 |
| SYNTHETIC EXAMINATION GLOVE, POWDERED (K981876) | Hsing YI Plastics Processing Co, Ltd. | 1998-09-30 |
| DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE (K982704) | Shanghai Antares Industries, Inc. | 1998-09-30 |
| POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE (K982807) | Perusahaan Getah Asas Sdn. Bhd. | 1998-09-30 |
| LIQUID IMMUNOLOGY CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS (K983130) | Kamiya Biomedical Co. | 1998-09-29 |
| ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS (K983241) | Kamiya Biomedical Co. | 1998-09-29 |
| PGK DEVICE (MODIFIED) (K980997) | Pgk, Inc. | 1998-09-28 |
| IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3 (K981226) | Dako Diagnostics , Ltd. | 1998-09-28 |
| GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820 (K974572) | Chugai Pharmaceuticals Co., Ltd. | 1998-09-24 |
| NBIL (K983134) | Abbott Laboratories | 1998-09-23 |
| DUAL PURPOSE CLOSED CATHETER (K982945) | Spirit Medical Systems, Inc. | 1998-09-22 |
| VTEC-RPLA SEIKEN (K981734) | Denka Seiken'S | 1998-09-22 |
| WAKO DIRECT LDL-C (K982271) | Wako Chemicals USA, Inc. | 1998-09-22 |
| BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST (K980798) | Princeton BioMeditech Corp. | 1998-09-22 |
| ELECSYS CALCHECK MYOGLOBIN (K983166) | Boehringer Mannheim Corp. | 1998-09-22 |
| JM-102 JAUNDICE METER (K972309) | Air-Shields, Inc. | 1998-09-22 |
| IMMUNODOT MONO-G TEST (K974226) | Genbio | 1998-09-22 |
| IMMUNODOT MONO-M TEST (K974244) | Genbio | 1998-09-22 |
| CLEAN SOURCE I, MODEL CS1000 (K981144) | Aquarius Technologies, Inc. | 1998-09-15 |
| PERIOVIEW MODEL DV-1 FIBERSCOPE AND WINDOW SHEATH. (K982480) | Dentalview, Inc. | 1998-09-15 |
| HDLC PRECIPITATING REAGENT (K982539) | Ac Biochemicals, Inc. | 1998-09-15 |
| OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS G2 AND G3 (K983127) | Medical Analysis Systems, Inc. | 1998-09-14 |
| LACTATE PRO SYSTEM (K980908) | Kdk Corp. | 1998-09-11 |
| RANDOX DIRECT LDL CHOLESTEROL (K982529) | Randox Laboratories, Ltd. | 1998-09-11 |
| FOAM TIP INJECTOR (K980696) | Staar Surgical Co. | 1998-09-11 |
| VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM (K982397) | Angiolaz, Inc. | 1998-09-10 |
| SURGEON'S GLOVE (K982589) | Shiva Medicare , Ltd. | 1998-09-10 |
| MAXAIR NASAL DILATOR SYSTEM (K982929) | Hnl Technologies | 1998-09-09 |
| PROXIDERM, MODELS TN 460, TN 90 460, BK 460 (K982439) | Progressive Surgical Products, Inc. | 1998-09-08 |
| AL-GEN CALCIUM ALGINATE DRESSING (K982234) | Innovative Technologies , Ltd. | 1998-09-08 |
| AQUACEL HYDROFIBER WOUND DRESSING (K982116) | Convatec, A Bristol-Myers Squibb Co. | 1998-09-08 |
| PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT (K982023) | Inova Diagnostics, Inc. | 1998-09-04 |
| FLUID CONTROL (K982117) | T.A. Coleman Ent. | 1998-09-04 |
| OMNI PRO LATEX SURGICAL GLOVE, POWDERED (K982613) | Omnigrace (Thailand) , Ltd. | 1998-09-02 |
| MODEL MS-2 HANDPIECE (K982050) | Parkell, Inc. | 1998-09-02 |
| MANUAL WHEELCHAIR (K982607) | G. Hirsch and Co., Inc. | 1998-08-31 |
| IVOC- INTEGRATED VOICE OPERATED CONTROL UNIT (IVOC-1) (K964977) | Interactive Living Systems, Inc. | 1998-08-31 |
| C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK) (K982442) | Care Wise Medical Products Corp. | 1998-08-25 |
| ONE UP DISPOSABLE KERATOME HEAD (K981742) | Moria, Inc. | 1998-08-25 |
| SUCTION CATHETER (K981910) | Ni-Med, Inc. | 1998-08-24 |
| WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM (K981937) | Welch Allyn, Inc. | 1998-08-24 |
| CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3 (K982845) | More Diagnostics | 1998-08-21 |
| VES 1501-M (K982409) | Angiolaz, Inc. | 1998-08-21 |
| KUSCHALL DESIGN K3/K4 SERIES OF MANUAL WHEELCHAIRS (K982336) | Invacare Corp. | 1998-08-21 |
| ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA (K981120) | Zeus Scientific, Inc. | 1998-08-21 |
| THERMATREK IRIS-3 INFRARED IMAGING SYSTEM (K982112) | Thermatrek, Inc. | 1998-08-20 |
| PLAQ-ATAQ-I (K980995) | Ethicare | 1998-08-20 |
| HICHEM CHOLESTEROL REAGENT KIT (K982469) | Elan Pharma, Inc. | 1998-08-19 |
| CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 (K980588) | Clarus Medical Systems, Inc. | 1998-08-18 |
| MB/BACT BLOOD CULTURE BOTTLE (K982263) | Organon Teknika Corp. | 1998-08-18 |
| INFRAMETRICS INFRACAM-MED (K982327) | Inframetrics, Inc. | 1998-08-18 |
| SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT (K982251) | Sigma Diagnostics, Inc. | 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 |
| NOSEBLEED NOSECLIP (K981966) | Michael M. Knott, M.D. | 1998-08-14 |
| FLAPMAKER DISPOSABLE MICROKERATOME (K981155) | Hawken Industries | 1998-08-14 |
| PYRILINKS-D ASSAY KIT (K981364) | Metra Biosystems, Inc. | 1998-08-13 |
| TUMOR MARKER CONTROL (K982473) | Diagnostic Products Corp. | 1998-08-12 |
| IMMULITE PSA CONTROL MODULE, MODEL LPSCM (K982637) | Diagnostic Products Corp. | 1998-08-12 |
| MARKWELL GAUZE SPONGE (K982260) | Markwell Intl., Inc. | 1998-08-12 |
| VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, AND III (K982649) | Ortho-Clinical Diagnostics, Inc. | 1998-08-12 |
| MICROALBUSTIX REAGENT STRIPS (K982219) | Bayer Corp. | 1998-08-12 |
| NITRILE POWDERFREE EXAMINATION GLOVES (K981877) | Besglove Medicare Sdn. Bhd. | 1998-08-11 |
| BREATHAID TONGUE SCRAPER (K981808) | Breathaid, LLC | 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 |
| BONETRAP (K980049) | Bladhs Plast AB | 1998-08-11 |
| POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED) (K982286) | Besglove Medicare Sdn. Bhd. | 1998-08-11 |
| PRO-FLEX DISPOSABLE PROPHY ANGLE (K981869) | Professional Dental Mfg., Inc. | 1998-08-11 |
| NITRILE PATIENT EXAMINATION GLOVE POWDER FREE (K982274) | Asia Pacific Latex Sdn Bhd | 1998-08-11 |
| POWDER FREE SURGEONS GLOVE (K982586) | Shiva Medicare , Ltd. | 1998-08-11 |
| IMMUNOWELL VCA IGM TEST (K973939) | Genbio | 1998-08-10 |
| IMMUNOWELL EBV VCA IGG TEST (K973940) | Genbio | 1998-08-10 |
| IMMUNOWELL EBNA IGG TEST (K973941) | Genbio | 1998-08-10 |
| DIGITAL DOC (K981663) | Digital Doc, LLC | 1998-08-10 |
| MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE (K980016) | Genzyme Surgical Product (Genzyme Biosurgery) | 1998-08-07 |
| SILON SCAR STRIPS (K982036) | Bio Med Sciences, Inc. | 1998-08-06 |
| B2-MICROGLOBULIN CONTROL SET SERUM (K982471) | Boehringer Mannheim Corp. | 1998-08-06 |
| STAT-SIMPLE PYLORI (K980782) | Saliva Diagnostic Systems, Inc. | 1998-08-05 |
| KELOCATE SHEETING (K982051) | Allied Biomedical Corp. | 1998-08-05 |
| DADE TRU-LIQUID CARDIAC CONTROL (K982591) | Dade Behring, Inc. | 1998-08-05 |
| SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR (K974648) | Sulzer Carbomedics, Inc. | 1998-08-04 |
| ANGIOLAZ VES-1CAM (K981819) | Angiolaz, Inc. | 1998-08-04 |
| POWDERED GREEN LATEX EXAMINATION GLOVES (K982284) | Besglove Medicare Sdn. Bhd. | 1998-08-03 |
| DIRECT LDL (K981303) | Abbott Laboratories | 1998-08-03 |
| VINYL PATIENT EXAMINATION GLOVES-PRE-POWDERED (K982257) | Taian Plastics Products (Jingxing) Co., Ltd. | 1998-08-03 |