| REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVE (K971514) | London International Group, Inc. | 1997-10-29 |
| AIR CONDUCTION HEARING AID (K973846) | Baron Trading, Inc. | 1997-10-29 |
| MSI PRESSURE INFUSOR (K973843) | Smith Assoc. | 1997-10-29 |
| IMMUSURE (K973894) | Quantimetrix Corp. | 1997-10-29 |
| THE MERETEK UBT BREATH TEST FOR H.PYLORI (K972352) | Meretek Diagnostics, Inc. | 1997-10-29 |
| ROYAL SHIELD NON-STERILE POWDERFREE, COLORED NITRILE EXAMINATION GLOVE (K972757) | Shield Gloves Manufacturer (M) Sdn Bhd | 1997-10-29 |
| MEDSTATION (K973090) | Program S.R.L. | 1997-10-28 |
| DUALINE 100 BTE (K973948) | Bernafon-Maico, Inc. | 1997-10-28 |
| AM SERIES HEARING AID (K973579) | A & M Hearing, Ltd. | 1997-10-28 |
| HYDRAGEL 7,15,30, CHOL-HDL KIT (K972015) | Morax | 1997-10-27 |
| OPUS HLH CONTROLS (K973832) | Behring Diagnostics, Inc. | 1997-10-27 |
| SPIFE (K972274) | Helena Laboratories | 1997-10-27 |
| RAPID FIRE HAIR IMPLANTER CAROUSEL (K972918) | Apex Medical Products, LLC | 1997-10-27 |
| MODEL C-1 HEARING AID (K973043) | Better Hearing, Inc. | 1997-10-27 |
| TBD* ONE-STEP OVULATION PREDICTOR TEST (K973310) | Armkel, LLC | 1997-10-27 |
| CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT (K972867) | Rocket Medical Plc | 1997-10-24 |
| PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING) (K972621) | Wembley Rubber Products (M) Sdn Bhd | 1997-10-24 |
| HANSATOME MICROKERATOME (K972808) | Chiron Vision Corp. | 1997-10-24 |
| FINALLY FREE (K972695) | Mehl/Group Marketing | 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 |
| ALLIANCE RUBBER, EC-GRIP (K972801) | Alliance Rubber Products Sdn. Bhd. | 1997-10-21 |
| POWDER-FREE LATEX EXAMINATION GLOVE, TEAL OR WHITE (NON-COLORED) (K973811) | Absolute Quality Leadership, Inc. | 1997-10-21 |
| DENTALVIEW PERIOVIEW SYSTEM (K973492) | Dentalview, Inc. | 1997-10-21 |
| ALGINATE/ZINC WOUND DRESSING (K973283) | Innovative Technologies , Ltd. | 1997-10-21 |
| DIGIFLEX SURGICAL GLOVES (K972277) | Hms Services, Inc. | 1997-10-21 |
| FEMASSIST URINARY DEVICE (K963858) | Insight Medical Corp. | 1997-10-21 |
| D72 DIGITAL (K972818) | Philips Hearing Instruments Co. | 1997-10-17 |
| SUNGLASSES (K973526) | Pyramid Handbags, Inc. | 1997-10-16 |
| QUIX RAPID E. COLI O157 STRIP TEST (K972156) | Guardian Scientific, Corp. | 1997-10-16 |
| LORI/LORI, LORI-S (LORI STOCK AID) (K973376) | Lori Medical Laboratories, Inc. | 1997-10-14 |
| TONGUE KLEAN (K973175) | Softek Ent. | 1997-10-14 |
| ABC LINEARITY VERIFIERS (K973790) | Sc Calibrators & Controls, LLC | 1997-10-14 |
| ABC CALIBRATION VERIFIERS (K973791) | Sc Calibrators & Controls, LLC | 1997-10-14 |
| LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET (K973157) | Pointe Scientific, Inc., | 1997-10-10 |
| LUBRIGLIDE (K973557) | Qualis, Inc. | 1997-10-10 |
| CBALK-1000 BLADE (K972727) | Howard Instruments, Inc. | 1997-10-10 |
| MAGO AUTOMATED EIA PROCESSOR (K973177) | Diamedix Corp. | 1997-10-09 |
| UNIVERSAL/1000 SERIES(101S101SDU1100)/ROLLS 2000(2000E)/TRANSPORT(M4) (K973418) | Assembly Required Dist., Inc. | 1997-10-09 |
| TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE (K973062) | Medidenta Intl., Inc. | 1997-10-09 |
| SNAP SWAB CULTURE COLLECTION AND TRANSPORT SYSTEM (K972726) | Medical Packaging Corp. | 1997-10-08 |
| ACCURUN 140 RUBELLA IGG POSITIVE CONTROL (K972986) | Boston Biomedica, Inc. | 1997-10-08 |
| E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION (K972569) | Nsk Nakanishi, Inc. | 1997-10-08 |
| VYKER SILICONE EPISTAXIS CATHETER V-27030, VYKER SILICONE EPISTAXIS CATHETER KIT V-2703K (K972922) | Interview Medical Technology Corp. | 1997-10-08 |
| MD100 & MM150 (K963913) | Konica Medical Corp. | 1997-10-08 |
| PRECINORM RF, PRECIPATH RF (K973629) | Boehringer Mannheim Corp. | 1997-10-07 |
| 2487 DUAL WAVELENGTH ABSORBANCE DETECTOR (K973074) | Waters Corporation | 1997-10-06 |
| MYOGLOBIN CONTROL SET (K973358) | Boehringer Mannheim Corp. | 1997-10-06 |
| MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE (K972169) | Pwa Industries Sdn. Bhd. | 1997-10-03 |
| VIDAS ROTAVIRUS (RTV) ASSAY (K972895) | Biomerieux Vitek, Inc. | 1997-10-03 |
| INNOVATOME MICROKERATOME (K973294) | Innovative Optics, Inc. | 1997-10-03 |
| REP SPE VIS-60/40 KIT (K973316) | Helena Laboratories | 1997-10-01 |
| REDYROB-CLOSED WOUND DRAINAGE SYSTEM (K972703) | B.Braun Medical, Inc. | 1997-10-01 |
| ULTRACELL SUCTION SPONGE (K972635) | Ultracell Medical Technologies, Inc. | 1997-10-01 |
| NAVIGATOR (STYLET) 2006 (K972521) | Sil-Med Corp. | 1997-10-01 |
| CONVATEC ODOR CONTROL WOUND DRESSING (K972530) | Convatec, A Division of E.R. Squibb & Sons | 1997-10-01 |
| PMT NEW BEGINNINGS GELSHAPES & AMEND (K972597) | Pmt Corp. | 1997-10-01 |
| SUNGLASSES (K973490) | Tong Yang Optical Co. | 1997-09-30 |
| SUNGLASSES (NON-PRESCRIPTION) (K973407) | Pacific Optical Co. , Ltd. | 1997-09-30 |
| XOMED T-STENT, FRONTAL SINUS STENT (K973273) | Xomed, Inc. | 1997-09-29 |
| PROSTATE SPECIFIC ANTIGEN CONTROL (K973099) | Dade Chemistry Systems, Inc. | 1997-09-29 |
| RETINOL BINDING PROTEIN RBP RID KIT (K973189) | The Binding Site, Ltd. | 1997-09-29 |
| MAS LIQUID URINALYSIS CONTROL LEVEL 1, LEVEL 2 AND LEVEL 3 (K973451) | Medical Analysis Systems, Inc. | 1997-09-29 |
| POCKET RESCUE (K970688) | Cheen Houng Ent. Co. , Ltd. | 1997-09-26 |
| NITRILE EXAMINATION GLOVES-PRE POWDERED (K970216) | Influx Pacific Sdn. Bhd. | 1997-09-26 |
| ASLI (K973473) | Texin Industrial (International) , Ltd. | 1997-09-26 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS (K973517) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-09-25 |
| FRESH CELLS WI-38 (K973212) | Diagnostic Hybrids, Inc. | 1997-09-25 |
| FRESH CELLS MV1LU (K973211) | Diagnostic Hybrids, Inc. | 1997-09-25 |
| FRESH CELLS NCI H292 (K973210) | Diagnostic Hybrids, Inc. | 1997-09-25 |
| SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY (K972761) | Sealite Sciences, Inc. | 1997-09-25 |
| FRESH CELLS VERO (K973209) | Diagnostic Hybrids, Inc. | 1997-09-25 |
| QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 AND 2, CONFORMANCEMCCLIQUICHEM UNASSAYED LIQUID CHEMISTRY CONTROL LEVELS (K973469) | Consolidated Technologies, Inc. | 1997-09-25 |
| FRESH CELLS HFF (K973214) | Diagnostic Hybrids, Inc. | 1997-09-25 |
| FRESH CELLS LLC-MK2 (K973213) | Diagnostic Hybrids, Inc. | 1997-09-25 |
| CHOLESTEROL RAPID LIQUID REAGENT (K972853) | Reagents Applications, Inc. | 1997-09-24 |
| VIOLA II DENTAL CAMERA SYSTEM (K973035) | Innovative Medical Systems, Inc. | 1997-09-24 |
| IMNET DICOM NETWORK AGENT (K972366) | Imnet Systems, Inc. | 1997-09-23 |
| EZ SPRAY (K972397) | Intertex Research, Inc. | 1997-09-23 |
| Z DEQ-II (K973266) | Electone, Inc. | 1997-09-23 |
| QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM (K972969) | Innovative Medical Technologies, Inc. | 1997-09-22 |
| DEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (K972580) | Bayer Corp. | 1997-09-22 |
| T1 LINE DENTAL HANDPIECES (K972436) | Siemens AG | 1997-09-22 |
| CONFORM NO POWDER (PROTEIN LABELING CLAIM) EXAMINATION GLOVES (K972785) | Ansell Perry | 1997-09-19 |
| RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE (K971508) | Bio-Whittaker, Inc., A Cambrex Co. | 1997-09-17 |
| NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASS (K973016) | Optimaxx Intl. | 1997-09-17 |
| SUNGLASSES (K972850) | Indoptica, S.A. | 1997-09-17 |
| COSMOPOST (K972875) | Ivoclar North America, Inc. | 1997-09-17 |
| OPPURTUNITY TRACHEOSTOMY CARE KIT (K971091) | Opportunity, Inc. | 1997-09-16 |
| OPPORTUNITY DRESSING CHANGE TRAY (K971090) | Opportunity, Inc. | 1997-09-16 |
| AUXILIARY INSTRUMENTS FOR URS (K971315) | Richard Wolf Medical Instruments Corp. | 1997-09-15 |
| WAKO NEFA LINEARITY SET (K973072) | Wako Chemicals USA, Inc. | 1997-09-12 |
| PURE ADVANTAGE NITRILE HYPOALLERGENIC SURGICAL GLOVE (K972009) | Tillotson Healthcare Corp. | 1997-09-12 |
| POWDERFREE COLORED AND FLAVORED NITRILE COPOLYMER PATIENT EXAMINATION GLOVES-MEDICAL DEVICE (K972306) | P.T. Irama Dinamika Latex | 1997-09-12 |
| DCI WATER PURIFIER (K971727) | Dental Components, Inc. | 1997-09-12 |
| BREATH-SO-FRESH TONGUE CLEANER (K972644) | Intl. Dental Design Specialists, Inc. | 1997-09-11 |
| KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL) (K972380) | Eastman Kodak Company | 1997-09-11 |
| IMPACT AIR 45 HANDPIECE FOR PERIODONTAL USE (K972376) | Glenwood, LLC | 1997-09-10 |
| IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USE (K972375) | Glenwood, LLC | 1997-09-10 |
| AMSINO SUCTION CATHETER (K973199) | Amsino Intl., Inc. | 1997-09-10 |