Atlas FDA

1987

4,160 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SYVA ETS SYSTEM (K863245)Syva Co.1987-03-13
AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS (K870025)American Research Products Co.1987-03-13
PROGRESS PLUS SELECTIVE CHEMISTRY ANALYZER (K870777)Kone Instruments, Inc.1987-03-13
SHBG IRMA KIT (K861679)Farmos Group , Ltd.1987-03-13
SUNGLASSES (K864543)Image of Hawaii1987-03-13
TDXR CANNABINOIDS (K864751)Abbott Laboratories1987-03-13
INSTAJECT (K870474)Pavel Jordan & Associates, Inc.1987-03-13
HEARING AID TEST SYSTEM MODEL HAT 1000 (K870229)Madsen Electronics (Canada) , Ltd.1987-03-13
EMG ELECTRODES AND EXTENSION CORDS (K870795)Nihon Kohden America, Inc.1987-03-13
ESI-1002 SYSTEM AND DC100S/C50M-P TRANSDUCER (K870964)Elscint, Inc.1987-03-13
BACPAC (TM), MODEL 6500 (K864968)Medical Devices, Inc.1987-03-13
UBIMAGIWEL(TM)HCG QUANTITATIVE AND QUALITATIVE (K864174)United Biotech, Inc.1987-03-13
PLATFORM MATTRESS W/DISPOSABLE BEDPAN BAG (K870166)George C. Kuhn1987-03-13
DAHLBERG MODEL UV TRIMLINE IN-THE-EAR HEARING AID (K870691)Dahlberg Electronics, Inc.1987-03-13
INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT (K870828)Intersect Systems, Inc.1987-03-13
FAST URIC ACID (K870632)Sclavo, Inc.1987-03-13
#014460-120 3-WAY & #014461-120 4-WAY STOPCOCK (K870324)Clinical Connections, Inc.1987-03-13
THYROID STIMULATING HORMONE (TSH IRMA) RIA KIT (K865071)Immuchem Corp.1987-03-13
DEPEND UNDERPAD (K870522)Kimberly-Clark Corp.1987-03-13
CO2 REAGENT SET (K864313)Hf Scientific, Inc.1987-03-13
INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT (K870827)Intersect Systems, Inc.1987-03-13
COAT-A-COUNT IRMA HCG KIT AND ITS COMPONENTS (K870106)Diagnostic Products Corp.1987-03-13
SCHULTZ PHALANGEAL COMPONENT DRIVER (K870847)Warsaw Orthopedic, Inc.1987-03-13
SCHULTZ METACARPAL COMPONENT DRIVER (K870848)Warsaw Orthopedic, Inc.1987-03-13
SCHULTZ PROSTHESIS COMPONENT INSERTER EXTRACTOR (K870844)Warsaw Orthopedic, Inc.1987-03-13
EPISON, ALERTING SYSTEM FOR EPILEPTICS (K862766)Zygo Industries, Inc.1987-03-13
S&W ELECTRODE TYPES 888, 844, 988 AND 944 (K864586)S & W Medico Teknik1987-03-13
RAICHEM(TM) PHOSPHORUS REAGENT, RAPID ENDPOINT (K870776)Reagents Applications, Inc.1987-03-13
EZ COMPLEMENT REAGENTS, 78N2212 (K870351)Diamedix Corp.1987-03-13
FAST GLUCOSE (K870631)Sclavo, Inc.1987-03-13
THE SCREENER GSI 55 ABR SCREENER (K870030)Grason-Stadler, Inc.1987-03-13
RING UPM TOTAL HIP REPLACEMENT (K864515)Downs Surgical , Ltd.1987-03-13
PREGELLED DISPOSABLE ELECTRODE, SILVER-SILVER (K865011)Labeltape Meditect, Inc.1987-03-13
BECKMAN EPSILON(TM) LIPASE TEST KIT (K864438)Beckman Instruments, Inc.1987-03-12
APO B., IMMUNOTURBIDIMETRIC ASSAY (K864228)Intl. Diagnostic Laboratories, Ltd.1987-03-12
AFFINITY(TM) HTSH IMMUNIT(TM) (K865081)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-03-12
ANA TEST KIT (K864668)Val Tech Diagnostics, Inc.1987-03-12
TOTAL/IGE THEOPHYLLINE CONTROL SERA (K870151)3M Company1987-03-12
OXY-THERM (K870832)M.D. Intl., Inc.1987-03-12
INFRALUX HEAT LAMP (K864714)Infralux International, Inc.1987-03-12
IQ FREE T4 IMMUNOASSAY (K864658)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-03-12
FERRITIN MAB SOLID PHASE COMPONENT SYSTEM (K870570)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-03-12
SOUNDTEK MODEL UT-4700 (K864766)Soundtek, Inc.1987-03-12
RICKETTSIAL IGG AND IGM IFA KIT (K864110)Hillcrest Biologicals1987-03-12
BENZODIAZEPINE ENZYME IMMUNOASSAY KIT (K863877)General Diagnostics1987-03-12
NIBP NON-INVAS. BLOOD PRESS. CART. MODEL 88 35 340 (K864737)Siemens Medical Solutions USA, Inc.1987-03-12
AFFINITY(TM) SYSTEM (K865105)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-03-12
MODIFIED IMAGEN(TM) CHLAMYDIA TEST (K864539)Boots-Celltech Diagnostics, Inc.1987-03-12
AUSTENAL ACUPAC 20 DENTURE BASE MATERIAL (K863630)Austenal Dental, Inc.1987-03-11
HEARING AID, UNITRON MODEL UM60 (K870503)Unitron Industries, Inc.1987-03-11
MODEL 78534C MONITOR/TERMINAL W/OPTIONS A03 (K870380)Hewlett-Packard Co.1987-03-11
TORQUEDRIVER WRENCH (K870053)Jerome Medical1987-03-11
PONTALLOR 4 DENTAL ALLOY (K870024)Degussa Dental, Inc.1987-03-11
MODEL MS-II MINISTIM (K870338)Life-Tech Intl., Inc.1987-03-11
TRACETS 2000/ELECTRODES (K863674)Lectec Corp.1987-03-11
WARSAW ORTHOPEDIC POINTED REAMER (K870845)Warsaw Orthopedic, Inc.1987-03-11
SPACELABS MODEL 90419 PULSE OXIMETER MODULE (K864279)Spacelabs, Inc.1987-03-11
MODEL 350 WIRELESS CROS/CROS LOW OUTPUT HEAR. AID (K870435)Telex Communications, Inc.1987-03-11
MODEL 350 WIRELESS BICROS/MULTICROS HEARING AIDS (K870434)Telex Communications, Inc.1987-03-11
ESCORT EC CUSTOM IN-THE-EAR HEARING AID (K870350)Hearing Tech, Inc.1987-03-11
ERA-20 (K853194)Biotronik Sales, Inc.1987-03-11
DIMENSION-WBG (K863223)Dimension Diagnostics1987-03-10
DIASONICS SPA 3.5 MHZ, 30MM PROBE (K864812)Diasonics, Inc.1987-03-10
EXTERNAL Y VALVE 5C4198 (K870145)Travenol Laboratories, S.A.1987-03-10
VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044 (K870259)Leeco Diagnostics, Inc.1987-03-10
LIFESOUND(TM) ESOPHAGEAL STETHOSCOPE W/THERMISTOR (K864858)Biomedical Concepts, Inc.1987-03-10
SEGURA DRETLER BASKET (K864874)Van-Tec, Inc.1987-03-10
VAN-TEC OPEN ENDED CONE TIP URETERAL CATHETER (K870694)Van-Tec, Inc.1987-03-10
DISPOS GEL EXTERNAL PACING ELECTRODE/LOW IMPEDANCE (K864985)Medac, Inc.1987-03-10
TEFLON BIOPSY CATHETER W/TIP ANGLE (K870734)Van-Tec, Inc.1987-03-10
OCEAN SCIENTIFIC VDRL TEST (K864731)Ocean Scientific, Inc.1987-03-10
VAN-TEC C-FLEX SUPRAPUBIC BALLOON CATHETER SET (K870556)Van-Tec, Inc.1987-03-10
DIASONICS SPA 5.O 27MM PROBE (K864758)Diasonics, Inc.1987-03-10
CARDIOFAX-V ECG-834OA (K865032)Nihon Kohden America, Inc.1987-03-10
VAN-TEC URETHRAL DILATATION SYSTEM (K870695)Van-Tec, Inc.1987-03-10
TANDEM(R)-M FSH IMMUNOENZYMETRIC ASSAY (K870520)Hybritech, Inc.1987-03-10
CARDIOFAX-V ECG-8240A (K865030)Nihon Kohden America, Inc.1987-03-10
BICARBONATE MIXING SYSTEM (K864942)Morris Tool , Ltd.1987-03-10
DIRECTIGEN MENINGITIS COMBO TEST & (B) STREP TEST (K870155)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-03-10
VAN-TEC ONE STEP URETERAL DILATATION CATHETER (K870697)Van-Tec, Inc.1987-03-10
WILLIAMS FLEXIBLE CYSTOSCOPIC INJECTION NEEDLE (K865086)Van-Tec, Inc.1987-03-10
EASY-TEST CREATINE KINASE-MB (CK-MB) #16615 (K870462)Em Diagnostic Systems, Inc.1987-03-10
VAN-TEC PEDIATRIC SUPRAPUBIC CATHETER SET (K870555)Van-Tec, Inc.1987-03-10
TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAY (K865057)Hybritech, Inc.1987-03-10
CARDIOMAX-II (K861543)Columbus Instruments Intl. Corp.1987-03-10
TERUMO DENTAL NEEDLES (K864970)Terumo Medical Corp.1987-03-10
RAT LIVER NUCLEI TEST SYSTEM (K870732)Val Tech Diagnostics, Inc.1987-03-10
PHOENIX-C ANESTHESIA MACHINE (K864644)American Anesthesia, Inc.1987-03-09
DYNEX III TRANSCUTANEOUS ELECTRICAL NERVE STIMULA. (K864956)La Jolla Technology, Inc.1987-03-09
CO2 LASER BRONCHOSCOPE SET (K870063)Tti Medical1987-03-09
ACROMED WALLIE-HEINIG CURETTES (K870778)Buckman Co., Inc.1987-03-09
DRIVER-BENDER-EXTRACTOR, BONE PIN (K870668)Military Engineering, Inc.1987-03-09
RADIATION ONCOLOGY COMPUTER SYS TREATMENT PLANNING (K862643)Pacific Physics, Inc.1987-03-09
VARIOUS TYES OF SURGICAL GARMENTS (K870617)Greene International Corp.1987-03-09
ELECTROSURGICAL MENISCUS CUTTER (EMC) MOD. AMC-100 (K870269)American Bentley1987-03-09
ACROMED WALLIE-HEINIG TROCHAR (K870779)Buckman Co., Inc.1987-03-09
HOOD BIFURCATED T-TUBE (K864533)Hood Laboratories1987-03-09
AMUKIN-50% FOR CAPD Y-SET (K862928)Amuchina Intl., Inc.1987-03-09
BAUMAN CPR/RESPIRATOR (K864308)General Medical Products, Inc.1987-03-09
VARIOUS TYPES OF SURGICAL GARMENTS (K870618)Kin Yuh Hung Co., Ltd.1987-03-09
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Track 1987 automatically

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