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32,815 FDA 510(k) clearances · Device class

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RecordFirmDate
MICROLITE TUBE LUMINOMETER #011-902-0000 (K890502)Dynatech Laboratories, Inc.1989-02-27
NIDEK AR-1200 (K890559)Nidek, Inc.1989-02-27
DACOS OR DACOS XL CLINICAL CHEMISTRY ANALYZER (K884378)Coulter Corp.1989-02-27
SUTTER HOSPITAL CPM (K890607)Sutter Corp.1989-02-27
CERVICAL BIOPSY FORCEPS (K890380)Kinetic Medical Products1989-02-27
ACUFEX FIXATION BUTTON (K884565)Acufex Microsurgical, Inc.1989-02-27
ENDOTHELIAL GROWTH MEDIUM (EGM) (K890701)Clonetics Corp.1989-02-24
ATS LUGOL'S IODINE SOLUTION (K890020)Alpha-Tec Systems, Inc.1989-02-24
HOLD-FAST DENTURE ADHESIVE (K884999)Iodent, Co.1989-02-24
BED, ADJUSTABLE, HOSPITAL, FOLDING, FIELD, W/O MAT (K885241)King Mfg. Co.1989-02-24
WRIGHT-GLEMSA STAIN (K890673)Sigma Diagnostics, Inc.1989-02-24
MELANOCYTE GROWTH MEDIUM (MGM) (K890700)Clonetics Corp.1989-02-24
ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET (K890674)Sigma Diagnostics, Inc.1989-02-24
17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA (K885198)Icn Biomedicals, Inc.1989-02-23
DELFIA PROGESTERONE KIT (K890428)Pharmacia, Inc.1989-02-23
DRENOVAC (K883982)Iberhospitex, S.A.1989-02-23
RESOUND HES, DIGITALLY PROGR., ITE HEARING AID (K884871)Resound Corp.1989-02-22
VITALON CHAIR MASSAGER MODEL V-CHR2 (K890643)Nexus Co. , Ltd. C/O Yama Trans Co. , Ltd.1989-02-22
SOLARETTES (K884878)Dioptics1989-02-22
CHOLESTEROL TEST ITEM NUMBER: SR1011 (K885023)Em Diagnostic Systems, Inc.1989-02-17
SPQ(TM) ANTIBODY REAGENT SET II FOR C3 (K890417)Atlantic Antibodies1989-02-17
RFA/2 RAPID FLOW ANALYZER W/COMPUTER (K890332)Alpkem Corp.1989-02-17
AXIOM ATRAUM WOUND DRAINS (K883887)Axiom, Inc.1989-02-17
JAMES REAGENT (K890625)Dms Products, Inc.1989-02-17
ALBUMIN REAGENT (K890333)Alpkem Corp.1989-02-17
BION DIRECT IDENTIFICATION CONTROL SLIDE (K890616)Bion Ent., Ltd.1989-02-17
MICROLITE CAMERA LUMINOMETER CL 1050 (0119010000) (K884782)Dynatech Laboratories, Inc.1989-02-17
HDL CHOLESTEROL REAGENT (PTA/MGCL2) (K890023)Sigma Diagnostics, Inc.1989-02-17
DRUG CONTROL SET (K884178)Gelman Sciences, Inc.1989-02-17
TECHNICON AXON(TM) SYSTEM (K885226)Technicon Instruments Corp.1989-02-17
HEMA(PRO)TEC(TION) (K885324)Medical Products Search, Inc.1989-02-17
PRO DISCS (K882630)Carr-Scarborough Microbiologicals, Inc.1989-02-16
MURINE MONOCLONAL ANTI-ADENOVIRUS IGG (K885310)Whittaker Bioproducts, Inc.1989-02-16
ALN DISCS (K882636)Carr-Scarborough Microbiologicals, Inc.1989-02-16
KODAK PORTABLE IDENTIFICATION CAMERA (K890467)Eastman Kodak Company1989-02-16
MICROSURGICAL KERATOME (K890216)Kinetic Medical Products1989-02-16
ENDOSTROBOSCOPE IV (K884933)Jedmed Instrument Co.1989-02-15
MALIS SURGICAL STOOL (K890309)Valley Forge Scientific Corp.1989-02-14
AIR DISPLACEMENT PIPETTE (K885340)Ulster Scientific, Inc.1989-02-14
MULTIWELL CULTURE PLATE INSERTS (K890542)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-02-14
FIXED-SIZE UTERINE DILATOR (K890377)Kinetic Medical Products1989-02-13
ADDIT. INDICATION FOR FYODOROV COLLAGEN CORNEAL (K884960)Bausch & Lomb Pharmaceutical, Inc.1989-02-13
IMPACTOR FOR FEMORAL HEAD (K890156)Dhason Brothers, Inc.1989-02-13
FORCEPS-ORTHOPEDIC (K890165)Dhason Brothers, Inc.1989-02-13
UTERINE CURETTE (K890384)Kinetic Medical Products1989-02-13
AUSTIN MOORE HALLOW CHISEL (K890163)Dhason Brothers, Inc.1989-02-13
NOVA DIAMOND (K885233)Microcopy, Div. Neo-Flo, Inc.1989-02-13
RETRACTOR, SELF-RETAINING (K890168)Dhason Brothers, Inc.1989-02-13
RETRACTORS (K890158)Dhason Brothers, Inc.1989-02-13
DENTAL IMPRESSION SYINGE (K890357)Innotek Dental Corp.1989-02-13
ABIOMED PERIOTEMP(TM) PROBE (K885075)Abiomed, Inc.1989-02-13
CP&S DISPOSABLE INSTANT COLD COMPRESS (K890553)Consolidated Products & Services, Inc.1989-02-13
CP&S DISPOSABLE INSTANT SUPER HOT COMPRESS (K890554)Consolidated Products & Services, Inc.1989-02-13
ADDIT. INDICATIONS FOR BIO-COR II COLLAGEN CORNEAL (K884961)Bausch & Lomb Pharmaceutical, Inc.1989-02-13
VAGINAL SPECULUM (K890375)Kinetic Medical Products1989-02-13
EXTRACTOR FOR AUSTIN MOORE FEMORAL HEAD (K890162)Dhason Brothers, Inc.1989-02-13
UMBILICAL SCISSORS (K890389)Kinetic Medical Products1989-02-13
THOMPSON TYPE RASP W/TOMMY BAR (K890161)Dhason Brothers, Inc.1989-02-13
FORCEPS (K890157)Dhason Brothers, Inc.1989-02-13
RONGUER-ORTHOPEDIC (K890166)Dhason Brothers, Inc.1989-02-13
HUDSON BRACE W/BURRS (K890164)Dhason Brothers, Inc.1989-02-13
SIT-N-BATHE SITZ BATH (K890085)Drummond Industries, Inc.1989-02-13
GOUGES FOR FEMORAL HEADS (K890160)Dhason Brothers, Inc.1989-02-13
HDL CHOLESTEROL TEST (K885265)Em Diagnostic Systems, Inc.1989-02-10
DENTAL CHAIR F1 (K884830)Fimet OY1989-02-10
IMX FOLLICLE STIMULATING HORMONE (FSH) (K890135)Abbott Laboratories1989-02-10
ABC, ABC-1X, ABC(TM) (K890482)Cell Ent., Inc.1989-02-10
SR30/SR50/SR60 AUTOMATED SEDIMENTATION RATE (K890503)Gespac, Inc.1989-02-10
SECOND ASSISTANT (K890501)3M Company1989-02-10
CLINISTAT TRIGLYCERIDES REAGENT TEST (K885134)Heraeus Kulzer, Inc.1989-02-10
DETECTABUSE DRUG CONTROLS (K890406)Eastern Laboratories, Ltd.1989-02-10
DENTAL SYRINGE APPLICATION TIP (K890064)Centrix, Inc.1989-02-10
IRON REAGENTS ITEM NUMBER: SR1017 (K890304)Em Diagnostic Systems, Inc.1989-02-10
PLASMA 40 INDUCT. COUPLED PLASMA EMMISSION SPECTRO (K884864)The Perkin-Elmer Corp.1989-02-10
MENISCUS MENDER II LOOP (K885311)Instrument Makar, Inc.1989-02-09
REPLICARE (ADDITIONAL CLAIMS) (K883849)United Medical1989-02-08
DERMASTRIP (K883660)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-02-08
(DATAGLOVE) HAND IMPAIRMENT EVALUATION SYSTEM (K884723)Greenleaf Medical Systems, Inc.1989-02-08
ZIPPIE & QUICKIE 2HP WHEELCHAIR (K890050)Motion Designs, Inc.1989-02-08
INTERA SHIELD AND INTERA UNDERGARMENT (K885185)Intera Corp.1989-02-08
DACOMED EXTERNAL MALE CONTINENCE DEVICE (K885323)Dacomed Corp.1989-02-08
ACETABULAR CUP PUSHER/IMPACTOR (K885305)Cobot Medical Corp.1989-02-08
CAPILLARY TUBE, BLOOD COLLECTION (K885138)Coeur Laboratories, Inc.1989-02-07
HIGH VOLUME PROFILER & DATA ENHANCEMENT PACKAGE (K885288)Eastman Kodak Company1989-02-07
MODIFIED INTENDED USE OF CLEANING REAGENT KIT (K890184)Hichem Diagnostics1989-02-07
OLYMPUS TRIGLYCERIDES REAGENTS #SR1021 (K885266)Em Diagnostic Systems, Inc.1989-02-07
STANBIO MAGNESIUM TEST SET, CAT. NO 0130 (K883170)Stanbio Laboratory1989-02-07
BACTIGEN(R) GROUP B STREPTOCOCCUS TEST (K885003)Armkel, LLC1989-02-07
MODIFIED INTENDED USE ON CLEANING NEUTRALIZER SOL. (K890183)Hichem Diagnostics1989-02-07
BACTIGEN(R) S. PNEUMONIAE (K884966)Armkel, LLC1989-02-07
KODAK EKTACHEM 700 ANALYZER FAMILY, SOFT V5.0 (K885289)Eastman Kodak Company1989-02-07
BACTIGEN(R) MENINGITIDIS PANEL (K884965)Armkel, LLC1989-02-07
GLOVE, SURGICAL (K884425)Med-Pak Corp.1989-02-06
GRAFT GUARD (K885136)Sorex Medical1989-02-06
A10 ULTRASCOPE RECORDER (K890142)Ems Medical, Inc.1989-02-06
SUPREME TONING SYSTEMS (K885095)Supreme Toning Systems1989-02-06
HANDLING & CUTTING DEVICE FOR IRIDIUM-192 WIRE PIN (K890191)Amersham Corp.1989-02-06
STERILE & NON-STERILE SURGEONS GLOVES (K882200)Taroko Ent., Ltd.1989-02-03
ABDOMINAL SPATULA (K890374)Kinetic Medical Products1989-02-03
PNEUMATIC DORSIFLEXOR (K890200)Medical Flotation Systems, Inc.1989-02-03
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