| DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT (K971742) | Depuy, Inc. | 1997-07-24 |
| COLORMATE III (K964590) | Chromatics Color Sciences Intl., Inc. | 1997-07-24 |
| REACH ANTIBACTERIAL TOOTHBRUSH (K971589) | Personal Products Co. | 1997-07-24 |
| PROTECTIVE RESTRAINT(MODELS #302,440,750 AND A30 X 30 BELT. (K972338) | Geriatric Products, Inc. | 1997-07-24 |
| MIRACLE-EAR DIGITAL BTE (K972344) | Miracle-Ear, Inc. | 1997-07-23 |
| STREP A OIA MAX (K962060) | Biostar, Inc. | 1997-07-23 |
| BETTER HEARING, INC. MODEL L-1 HEARING AID (K971298) | Better Hearing, Inc. | 1997-07-23 |
| MIRACLE-EAR ITE DIGITAL (K972346) | Miracle-Ear, Inc. | 1997-07-23 |
| JAZZ PP AGC-O, JAZZ PP (K972542) | Trutone | 1997-07-23 |
| TWIST PPAGC-1, TWIST PP (K972543) | Trutone | 1997-07-23 |
| DAHLBERG/MIRACLE-EAR (K972345) | Miracle-Ear, Inc. | 1997-07-23 |
| MERIDIAN DSP (K972431) | Micro-Ear Technology, Inc. | 1997-07-23 |
| PERSONALLAB AUTOMATED MICROPLATE ANALYZER (K971761) | Biochem Immunosystems (U.S.), Inc. | 1997-07-22 |
| VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE) (K972404) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1997-07-22 |
| EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5) (K972041) | Sigma Diagnostics, Inc. | 1997-07-22 |
| TOX A/B TEST (K971182) | Techlab, Inc. | 1997-07-22 |
| QUANTA LITE RUBEOLA (MEASLES) IGG (K971620) | Inova Diagnostics, Inc. | 1997-07-22 |
| ANTIBACTERIAL GUTTA PERCHA (K971641) | Dr. Howard Martin, P.A. | 1997-07-21 |
| MOMO DESIGN OR MOMO (K972416) | Momo U.S.A., Inc. | 1997-07-21 |
| BREATH ACE BREATHFRESHENER (K972131) | Beyond 21st Century, Inc. | 1997-07-18 |
| BIVALVE NASAL SPLINT (K972096) | Boston Medical Products, Inc. | 1997-07-15 |
| UNIJECT SURGICAL GLOVES (K970160) | Uniject Gloves , Ltd. | 1997-07-15 |
| N-ASSAY TIA MULTI V-NL (K964299) | Crestat Diagnostics, Inc. | 1997-07-14 |
| LATEX EXAMINATION GLOVES (K970770) | Oon Corp. Resources | 1997-07-14 |
| GANTEX MODEL NSG-75PF (K962539) | American Pro Latex, Inc. | 1997-07-14 |
| FOVS, BRILLARTE, ETC... (K972362) | Sunglass City, Inc. | 1997-07-14 |
| PROVEST-PROTECTIVE RESTRAINT (K971561) | Jemm Medical Products | 1997-07-14 |
| MYCOPLASMA IGG ELISA TEST SYSTEM (K971393) | Immunoprobe, Inc. | 1997-07-14 |
| SUNGLASSES (K971385) | Kosway Industries Co., Ltd. | 1997-07-14 |
| PURE ADVANTAGE POWDER FREE NITRILE HYPOALLERGENIC SURGICAL GLOVE (K971945) | Tillotson Healthcare Corp. | 1997-07-14 |
| ALLEN, ULTRA AND SMART SOCKETS (K971988) | Allen Medical Systems, Inc. | 1997-07-11 |
| FAR-EAST SHOE COVERS (K971191) | Far East Science & Technology Development Co., Ltd. | 1997-07-10 |
| FAR-EAST BOUFFANT CAPS (K970988) | Far East Science & Technology Development Co., Ltd. | 1997-07-10 |
| POST-STOP EPISTAXIS CATHETER (K972078) | Boston Medical Products, Inc. | 1997-07-10 |
| EPITECH ISLAND DRESSINGS (K971337) | Rynel, Ltd. Inc. | 1997-07-09 |
| POWDER-FREE DURAPRENE STERILE SYNTHETIC SURGICAL GLOVES (K971381) | Allegiance Healthcare Corp. | 1997-07-09 |
| INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE (K971079) | Interlogics, Inc. | 1997-07-09 |
| QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS (K972146) | Consolidated Technologies, Inc. | 1997-07-08 |
| DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD) (K971342) | Disk Whisk, Inc. | 1997-07-08 |
| NASAL AIRWAY SPLINT (K972092) | Boston Medical Products, Inc. | 1997-07-08 |
| DOYLE COMBO NASAL AIRWAY SPLINT (K972151) | Boston Medical Products, Inc. | 1997-07-07 |
| BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST (K971349) | Princeton BioMeditech Corp. | 1997-07-07 |
| PRECINORM TDM CONTROLS (K971060) | Boehringer Mannheim Corp. | 1997-07-07 |
| IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK (K971473) | M-Pact Worldwide Management Corp. | 1997-07-07 |
| DADE TRU-LIQUID BILIRUBIN CONTROL (K972287) | Dade Intl., Inc. | 1997-07-07 |
| PEFECT SHOT (K972019) | International Imaging Electronics | 1997-07-03 |
| UNIJECT EXAMINATION GLOVES (K970191) | Uniject Gloves , Ltd. | 1997-07-03 |
| CUSTOM NASAL SPLINT (K972082) | Boston Medical Products, Inc. | 1997-07-03 |
| SMART - FIT, PREPOWDERED NITRILE EXAMINATION GLOVES (K971666) | Sj Medical Products (M) Sdn Bhd | 1997-07-03 |
| PURE COMPANY FLUID DELIVERY SYSTEM (K971278) | Pure Co. | 1997-07-03 |
| BONE & MARROW CLLECTION SYSTEM (K971268) | Biomedical International Corp. | 1997-07-03 |
| NOVIGUARD QUICK DRY (K961044) | Dr. Novis Smith & Co., Inc. | 1997-07-03 |
| MEDISURF (K971347) | International Regulatory Consultants | 1997-07-03 |
| ARGOSY DYNAMEQ (K971699) | Argosy Electronics | 1997-07-03 |
| RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (K971605) | Resound Corp. | 1997-07-03 |
| SUNGLASSES (K971462) | D.G. Prove Co. | 1997-07-01 |
| (BRAND NAME) (K971384) | Long IN Time Ent. Co., Ltd. | 1997-07-01 |
| RESTRAINTS (VESTS AND JACKETS) (K971536) | E.M. Adams Co., Inc. | 1997-07-01 |
| TWEEZER-TYPE EPILATOR (K970338) | Igia Direct, Inc. | 1997-07-01 |
| RCT GEL ROOT CANAL THERAPY GEL (K972234) | Dentsply Intl. | 1997-06-30 |
| MASTERCAP AM 5.0/MASTERCAP RM 5.0 (K970420) | Pharmacia, Inc. | 1997-06-30 |
| PYLORISET EIA-G (68926) (K971537) | Orion Diagnostica, Div. Orion Corp. | 1997-06-27 |
| AMSCO SURGICAL TABLE (K971307) | STERIS Corporation | 1997-06-27 |
| LATEX EXAMINATION GLOVES, POWDER FREE (K970977) | Arista Medi Prima | 1997-06-27 |
| SMART - FIT, POWDERFREE NITRILE EXAMINATION GLOVES (K971665) | Sj Medical Products (M) Sdn Bhd | 1997-06-27 |
| AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM (K971103) | Tosoh Medics, Inc. | 1997-06-27 |
| SPECTACLE FRAMES (NON-PRESCRIPTION) (K972246) | Alimar Trading, Inc. | 1997-06-26 |
| EPI-MAX EPISTAXIS CATHETER (K972076) | Boston Medical Products, Inc. | 1997-06-26 |
| SYNERMED IR 200 CHEMISTRY ANALYZER (K971491) | Synermed, Inc. | 1997-06-26 |
| NICHOLS ADVANTAGE CHEMILUMINESCENCE TRI-LEVEL SPECIALTY CONTROLS (K972070) | Nichols Institute Diagnostics | 1997-06-26 |
| EPI-STOP EPISTAXIS CATHETER (K972077) | Boston Medical Products, Inc. | 1997-06-26 |
| WISE IMAGE MANAGEMENT SYSTEM (K971451) | O Tech, Inc. | 1997-06-26 |
| NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES (K971167) | Neoprobe Corp. | 1997-06-26 |
| MULTIPICS(ME-977) (K971154) | Merlin Engineering Works, Inc. | 1997-06-25 |
| SPLITSCREEN (ME-975) (K971153) | Merlin Engineering Works, Inc. | 1997-06-25 |
| SUNGLASSES (NON-PRESCRIPTION) (K972014) | Tamfort, Ltd. | 1997-06-24 |
| POWDER - FREE LATEX EXAMINATION GLOVES APPLICATION (K964826) | Kossan Latex Industries(M)Sdn Bhd | 1997-06-24 |
| ELASTYREN POWDER-FREE PATIENT EXAMINATION GLOVES (K970015) | Eci Medical Technologies, Inc. | 1997-06-24 |
| PLUSTRON ION TOOTHBRUSH SYSTEM (K971639) | Sas Group, Inc. | 1997-06-24 |
| RIVIERA SUNGLASS4ES (K972194) | Riviera Optical Co., Ltd. | 1997-06-24 |
| PROLACTIN (PRL) HORMONE MICROPLATE ELISA (K971921) | Monobind | 1997-06-24 |
| CEBE (K971644) | Suunto USA | 1997-06-24 |
| DEGANIA SILICONE SIL-K (K971482) | Degania Silicone , Ltd. | 1997-06-24 |
| ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN) (K972214) | Roche Diagnostic Systems, Inc. | 1997-06-24 |
| VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070) (K972133) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-06-24 |
| LOW PROTEIN LATEX EXAMINATION GLOVES (K970222) | Kossan Latex Industries(M)Sdn Bhd | 1997-06-24 |
| LYPHOCHEK REMEDI CONTROL (K972174) | Bio-Rad | 1997-06-24 |
| TONDI, MODELS U-03, U-2M1, U-2M4, KA-01, KA-02, KA-03, KA-03A, KA-04, KA-04A, KA-05 (K971296) | National Hearing Aid Dist., Inc. | 1997-06-20 |
| TRIGLYCERIDES, TG, OR TRIG (K971324) | Carolina Liquid Chemistries Corp. | 1997-06-20 |
| NSK PUSH-BUTTON MIDWEST REPLACEMENT TURBINE:FOR QUIETAIR AND TRADITION (K971774) | Nsk Nakanishi, Inc. | 1997-06-20 |
| PLANMECA INTRACAM (K972033) | Planmeca Oy | 1997-06-20 |
| CHOLESTEROL REAGENT (K971072) | Derma Media Lab., Inc. | 1997-06-20 |
| INDICARD TEST (K964015) | Litmus Concepts, Inc. | 1997-06-19 |
| INFECTION CONTROL CARTRIDGE (K964942) | Dentalpure Corp. | 1997-06-19 |
| GRAFT HARVESTING SAWBLADES (K971978) | Wrightmedicaltechnologyinc | 1997-06-18 |
| N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET (K971573) | Genzyme Corp. | 1997-06-18 |
| OPUS PROGESTERONE (K971725) | Behring Diagnostics, Inc. | 1997-06-18 |
| QUALITROL DHP IMMUNOASSAY CONTROL LEVELS 1,2 AND 3, CONFORMANCEE MCC-LIGAND CONTROL LEVELS 1, 2 AND 3 (K972080) | Consolidated Technologies, Inc. | 1997-06-18 |
| DANAVOX MODELS 163/162 BTE (K971032) | Gn Danavox, Inc. | 1997-06-17 |
| AUDALLION III HEARING SYSTEM (K971031) | Gn Danavox, Inc. | 1997-06-17 |