Atlas FDA

1989

5,030 FDA 510(k) clearances · Clearance year

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RecordFirmDate
TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDING (K885010)Coe Laboratories, 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
ULTRA 2000 (T.E.N.S.) (K884833)Maxima Intl., Inc.1989-02-13
GOLD/PALLADIUM BASED DENTAL ALLOY (K885302)Jelenko Co.1989-02-13
UTERINE TENTACULUM (K890379)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
ULTRASONIC TRANSMISSION GEL (K884503)Herbert Stanley Co.1989-02-13
AUDIOSCAN(TM) REAL EAR MEASUREMENT SYSTEM RM500 (K884046)Etymonic Design, Inc.1989-02-13
PATIENT MOVER(TM) (K890555)T.B.S., Inc.1989-02-13
MADSEN IGO1500 INSERTION GAIN OPTIMIZER (K884372)Madsen Electronics (Canada) , Ltd.1989-02-13
MODEL 27080 CALCUTRIPT ELECTROHYDRAULIC LITHR SYS (K883189)KARL STORZ Endoscopy-America, 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
UTERINE DRESSING FORCEPS (K890378)Kinetic Medical Products1989-02-13
ALTA TIBIAL/UPPER EXTREMITY METAPHYSEAL PLATE SYS (K885250)Howmedica Corp.1989-02-13
GOUGES FOR FEMORAL HEADS (K890160)Dhason Brothers, Inc.1989-02-13
AQUACISER SYSTEM (K890548)Aquaciser, Inc.1989-02-13
SUPERCAIR (K890523)Ssi Medical Services, Inc.1989-02-10
MODIFIED ANCOR & HI-FLEX UNIPOLAR ACTIVE FIX. LEAD (K885240)Tpl-Cordis, Inc.1989-02-10
AFP MODEL 262T PULSE GENERATOR (K884733)Pacesetter Systems1989-02-10
ABSORBENT GAUZE ROLL (K885143)Smith & Nephew, Inc.1989-02-10
HDL CHOLESTEROL TEST (K885265)Em Diagnostic Systems, Inc.1989-02-10
DENTAL CHAIR F1 (K884830)Fimet OY1989-02-10
CREATINE KINASE-MB TEST (CK-MK) ITEM NUMBER 65673 (K884547)Em Diagnostic Systems, Inc.1989-02-10
EMIT(R) D.A.U AMPHETAMINE CLASS LOW CALIBRATOR (K890451)Syva Co.1989-02-10
IMX FOLLICLE STIMULATING HORMONE (FSH) (K890135)Abbott Laboratories1989-02-10
IL PHOENIX, MODEL 900, CHEMISTRY/ELECTROLYTE ANALY (K884771)Instrumentation Laboratory CO1989-02-10
AME PINSITE SHIELD(TM) (K884798)American Medical Electronics, Inc.1989-02-10
ABC, ABC-1X, ABC(TM) (K890482)Cell Ent., Inc.1989-02-10
SR30/SR50/SR60 AUTOMATED SEDIMENTATION RATE (K890503)Gespac, Inc.1989-02-10
EMIT(R) D.A.U. AMPHETAMINE CLASS MEDIUM CALIBRATOR (K890452)Syva Co.1989-02-10
SURGI-CUF STERILE/NON-STERILE DISPOSABLE (K883977)Ethox Corp.1989-02-10
VENTREX COATED TUBE HIGH SENSITIVITY TSH (K885157)Ventrex Laboratories, Inc.1989-02-10
DADC '500' DRIVING CONTROL (K884899)Driving Aids Development Corp.1989-02-10
SECOND ASSISTANT (K890501)3M Company1989-02-10
BIOTROL ALBUMIN (K885094)Biotrol, USA, Inc.1989-02-10
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
STERI-OSS (K884845)Denar Corp.1989-02-10
PLASMA 40 INDUCT. COUPLED PLASMA EMMISSION SPECTRO (K884864)The Perkin-Elmer Corp.1989-02-10
HEMO-SANITAS SYRINGE (K884921)Hemo-Sanitas, Inc. C/O Greenberg Irwin & Weisinger1989-02-09
ANESTY 10 (K880744)Nihon Medix Co., Ltd.1989-02-09
POLARIX 2 AND POLARIX 2E (K884578)Dyna-Med1989-02-09
3D/DENTAL (K885322)Columbia Scientific, Inc.1989-02-09
INTERLABIAL PAD (K881384)Xtramedics, Inc.1989-02-09
CANDELA STONE BASKETS (K884738)Candela Laser Corp.1989-02-09
MENISCUS MENDER II LOOP (K885311)Instrument Makar, Inc.1989-02-09
CENTURION(TM) MIXER (K884879)Matrix Medica, Inc.1989-02-09
AXOSTIM (K883807)Singer Medical Products, Inc.1989-02-09
CERVICAL BRUSH (K884873)Statlab Medical Products, Inc.1989-02-09
REPLICARE (ADDITIONAL CLAIMS) (K883849)United Medical1989-02-08
HEOMDIALYSIS SINGLE PATIENT SYSTEM (SPS) MODEL 650 (K883111)Baxter Healthcare Corp1989-02-08
DERMASTRIP (K883660)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-02-08
(DATAGLOVE) HAND IMPAIRMENT EVALUATION SYSTEM (K884723)Greenleaf Medical Systems, Inc.1989-02-08
VIRGO (R) CMV-IGG ELISA (K883102)Electro-Nucleonics, Inc.1989-02-08
MODIFIED UNIVERSAL ACETABULAR CUP SYSTEM (UACS) (K883661)Depuy, Inc.1989-02-08
LAKE N/G FEEDING TUBE (K884127)Lake Medical Products, Inc.1989-02-08
NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI (K884789)Protek, Inc.1989-02-08
THE CARPENTIER TRANS-MITRAL VENTRICULAR VENT(TM) (K883412)Promedica Products, Inc.1989-02-08
ZIPPIE & QUICKIE 2HP WHEELCHAIR (K890050)Motion Designs, Inc.1989-02-08
CAPILLARY FLOW DIALYZERS MODELS CT110G & CT190G (K890315)Baxter Healthcare Corp1989-02-08
INTERA SHIELD AND INTERA UNDERGARMENT (K885185)Intera Corp.1989-02-08
GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER (K890111)Gambro, Inc.1989-02-08
DACOMED EXTERNAL MALE CONTINENCE DEVICE (K885323)Dacomed Corp.1989-02-08
DACA-100 (K882933)Visual Cybernetics1989-02-08
CONTINUUM KNEE SYSTEM (CKS) (K882322)Buckman Co., Inc.1989-02-08
LUMED EXPANDO-CATH, ACTIV (K884806)Luther Medical Products, Inc.1989-02-08
M.E.M. ACETABULAR CUP W/SULMESH FOR CEMENT APPLI. (K890054)Protek, Inc.1989-02-08
AMERLITE FT3 ASSAY, LAN.0007/2007 240/144 TEST KIT (K885195)Amersham Corp.1989-02-08
FLUID DRAINAGE WICK (K885232)Visitec Co.1989-02-08
ACETABULAR CUP PUSHER/IMPACTOR (K885305)Cobot Medical Corp.1989-02-08
SURGITEK (R) UROFLOW SYSTEM (K883274)Medical Engineering Corp.1989-02-08
DIFCO DIRECTOR INOCULATION SYSTEM (K890339)Difco Laboratories, Inc.1989-02-07
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
MODIFIED MODEL 1000 OPTILASE(TM) ND:YAG LASER (K890279)Trimedyne, Inc.1989-02-07
BACTIGEN(R) N. MENINGITIDIS (K885004)Armkel, LLC1989-02-07
MODIFIED LABYSYSTEMS' TOXOPLASMA GONDII IGG EIA (K890154)Labsystems, Inc.1989-02-07
OLYMPUS TRIGLYCERIDES REAGENTS #SR1021 (K885266)Em Diagnostic Systems, Inc.1989-02-07
STANBIO MAGNESIUM TEST SET, CAT. NO 0130 (K883170)Stanbio Laboratory1989-02-07
CRACK-IT CHAP SCREEN (K874389)Sakers, Inc.1989-02-07
CEDIA THEOPHYLLINE ASSAY (K884358)Microgenics Corp.1989-02-07
ORTHO* TOXOPLASMA-G ANTIBODY ELISA TEST (K883937)Ortho Diagnostic Systems, Inc.1989-02-07
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) H. INFLUENZAE TYPE B (K884967)Armkel, LLC1989-02-07
ADDIT. ALLERGENS TO INCLUDE FOODS FOR ALLERG*ENS (K885269)Dexall Biomedical Labs, Inc.1989-02-07
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Track 1989 automatically

Every clearance here is in the API, with alerts when new ones post.