Atlas FDA

1984

4,397 FDA 510(k) clearances · Clearance year

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RecordFirmDate
RHYS-DAVIES EXSANGUINATOR (K842963)Woodville Polymer Engineering, Ltd.1984-08-17
MIN. ESSENTIAL MED. W/L-GLUTAMINE, RIB (K842775)Sigma Chemical Co.1984-08-17
HOSPITAL'S-SPEC (K842014)Merex Co.1984-08-17
FSH RIA (K842444)Syncor Intl. Corp.1984-08-17
TECHNICARE 248 SL & 260SL (K841817)Technicare Corp.1984-08-17
TECHNICON RA-1000 SYS, DIRECT BILIRUBIN (K842809)Technicon Instruments Corp.1984-08-17
AIMED SCALP VEIN SET VARIOUS (K842255)Tech-Cons Ltd., Intl.1984-08-17
BLOOD GAS FLUSH SOL. & FLUSH AGENT 1302 (K842519)Rna Medical Corp.1984-08-17
SKIN SCRUB TRAY STERILE SKIN SCRUB KIT (K842490)Biological & Environmental Control Laboratories1984-08-17
DELAFIELD HEMATOXYLIN STAIN (K842740)E K Ind., Inc.1984-08-17
PHYSIOLOGICAL ANALYZER CM-710 (K842782)Cybermedic, Inc.1984-08-17
FINE NEEDLE ASPIRATION DEVICE (K841275)Gyneco, Inc.1984-08-17
MICROPOROUS HYPOALLERGENIC (K840946)Gainor Medical1984-08-17
MATRIS INSTRU. VIDEO IMAGER 1010- (K842494)Matrix Instruments1984-08-17
PAP STAIN EA-50 (K842738)E K Ind., Inc.1984-08-17
MATRIX VIDEO IMAGER 1020 COMPACT CAMER (K842495)Matrix Instruments1984-08-17
LUSTER, DENTAL POLISHING PASTE (K842403)Scientific Pharmaceuticals, Inc.1984-08-17
AMES TDA PHENOBARBITAL TEST (K842592)Miles Laboratories, Inc.1984-08-17
PAP STAIN, OG-6 (K842736)E K Ind., Inc.1984-08-17
GRASSHOPPER - RETRACTOR (K842992)Norton Texas Medical Products1984-08-17
SPX GENERATOR (K842348)General Electric Co.1984-08-17
TRIPLE SUGAR IRON (K842850)Anarobe Systems1984-08-17
ETI TENS BELT (K843119)Electro Therapeutic Devices, Inc.1984-08-17
DISPOS. & SPONGE FORCEPS PEAN ARTERY (K843074)Greene International Corp.1984-08-17
ACCESS. TO INTERAVACULAR ADMIN. SET (K842657)Tanner Corp.1984-08-17
BOUNDARY SINGLE-USE OR GOWN (K842958)Procter & Gamble Mfg. Co.1984-08-17
FOX POST NASAL BALLOON CATHETER (K841040)Inmed Corp.1984-08-17
OSMOTIC PRESSURE AUTO & STAT OM-6010 (K842750)Kyoto Diagnostics, Inc.1984-08-17
SEWON DENTAL FLOSS FOLDER (K842846)Sewon Industry1984-08-17
SILIMED BREAST FORM (K842765)Sil-Med Corp.1984-08-17
ACA CONJUGATED BILIRUBIN ANALYTICAL (K842385)E.I. Dupont DE Nemours & Co., Inc.1984-08-17
DENTI-D RUBBER DAM (K842844)Fema Corp.1984-08-17
MICRO-TEMP PUMPS & MICRO-TEMP PADS (K843146)Seabrook Medical Systems, Inc.1984-08-17
VINYL EXAM GLOVES, NON-STERILE (K843016)Abco Dealers, Inc.1984-08-17
FLU MET 2 (K842088)Venusa , Ltd.1984-08-17
CLEAR PLASTIC-HYPOALLERGENIC (K840949)Gainor Medical1984-08-17
CLOTH-HYPOALLERGENIC (K840947)Gainor Medical1984-08-17
ARGYLE ENTERITE ENTERAL FEEDING PUMP (K842421)Sherwood Medical Co.1984-08-17
OMNI-TRACT SURGICAL RETRACTOR SYS (K842762)Minnesota Scientific, Inc.1984-08-17
MAXIFILL TRANSFER SET (K842345)Lyphomed, Inc.1984-08-17
COAT-A-COUNT DHEA RIA KIT (K842606)Diagnostic Products Corp.1984-08-17
MUELLER HINTON BROTH (K842854)Anarobe Systems1984-08-17
CURITY I.V. START KIT (K842898)The Kendal Co.1984-08-17
DISPOSABLE SKIN MARKING PEN (K843116)E.M. Adams1984-08-17
LITHIUM REAGENT (K841847)Reagent Laboratory, Inc.1984-08-17
AMER. EDWARDS LAB FLEXISCOPE OBTURATOR (K842323)American Edwards Laboratories1984-08-17
CDX80 (K842536)Cdx Corp.1984-08-17
SHILEY VENOUS RESERVOIR (K842337)Shiley, Inc.1984-08-17
CHOLESTEROL ASSSAY KIT (K842160)Diagnostic Chemicals, Ltd. (Usa)1984-08-17
TDX DIGITOXIN (K842280)Abbott Laboratories1984-08-16
IMMPULSE DIGOXIN ASSAY REAGENTS (K842571)Aktis Corp.1984-08-16
HICHEM ION 2/4 SERUM RANGE CALIBRATOR (K842449)Hi Chem, Inc.1984-08-16
CORTI-COTE CORTISOL SOLID PHASE RADIO (K842365)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-08-16
ACCU-CULT FECAL OCCULT BLOOD TEST (K840904)Applied Medical Devices, Inc.1984-08-16
PICOSCAL BLOOD CELL COUNTER PS-4 (K842140)Diagnostic Technology, Inc.1984-08-16
BOEHRINGER MANNHEIM DIAG. BLOOD GLUCOSE (K842393)Boehringer Mannheim Corp.1984-08-16
STREPTEX DIRECT A ZL14 (K842827)Wellcome Diagnostics1984-08-16
DATA MGMT. SYSTEM (K842500)Gilford1984-08-16
HICHEM ION 2/4 URINE RANGE CALIBRATOR (K842450)Hi Chem, Inc.1984-08-16
ACA ACETAMINOPHEN ANALYTICAL TEST PACK (K842548)E.I. Dupont DE Nemours & Co., Inc.1984-08-16
EPSILON DIGOXIN TEST KIT (K842655)Beckman Instruments, Inc.1984-08-16
AMER. BIO-SCIENCE LAB CORTISOL REAGENT (K842455)American Bio-Science Laboratories1984-08-16
CREATININE ASSAY KIT-KINETIC OR ENDPOINT (K842159)Diagnostic Chemicals, Ltd. (Usa)1984-08-16
ACA ACETAMINOPHEN CALIBRATOR (K842549)E.I. Dupont DE Nemours & Co., Inc.1984-08-16
HOLLOW FIBER DIALYZERS (K840845)Travenol Laboratories, S.A.1984-08-16
AXIOM STABLE II URIC ACID TEST (K842442)Axiom, Inc.1984-08-16
WAKO LDH CII TEST (K842452)Wako Chemicals USA, Inc.1984-08-15
GAUZE & LAB SPONGES STERILE & NON (K842572)Ulti-Med Intl., Inc.1984-08-15
ACA BENZODIAZEPINES SCREEN TEST PK (K842387)E.I. Dupont DE Nemours & Co., Inc.1984-08-15
THE SUTURER (K842912)Vlm Surgical, Inc.1984-08-15
SITE SIMCOE STYLE I/A HANDPIECE (K842458)Chiron Vision Corp.1984-08-15
ESOPHAGEAL STETHOSCOPE (K842865)Inmed Corp.1984-08-15
OXYGEN CONCENTRATOR (K842753)Bv Medical Equipment Co.1984-08-15
SIDE CUTTING SERRATED BLADE (K841980)Stainless Mfg., Inc.1984-08-15
PORTABLE ACUIOMETER (K842567)Randwal Instrument Co., Inc.1984-08-15
SITE GILLS STYLE I/A HANDPIECE (K842459)Chiron Vision Corp.1984-08-15
TDX REA CHOLESTEROL (K842320)Abbott Laboratories1984-08-15
GIEMSA STAIN (K842742)E K Ind., Inc.1984-08-15
ACU-DERM TRANSPARENT IV DRESSING (K842064)Acme United Corp.1984-08-15
AMERI. MEDICAL OPTICS ARGON LASER PHOTO (K842251)American Medical Optics1984-08-15
AMER. MEDICAL OPTICS ARGON/KRYPTON LASE (K842250)American Medical Optics1984-08-15
GILL HEMATOXYLIN STAIN (K842741)E K Ind., Inc.1984-08-15
DR. GOULD HAND PACK SUSTOM STERIL (K842405)Pro-Lab, Inc.1984-08-15
ACU220 CRYO UNIT (K841294)Keller Instruments, Inc.1984-08-15
CLINITEK 200 SEMI-AUTOMATED URINALYSIS (K842237)Miles Laboratories, Inc.1984-08-15
COLOR OPTIC CORNEAL EYE SHIELD (K840414)Diversations, Inc.1984-08-15
STREPTEX ZL01 (K842828)Wellcome Diagnostics1984-08-15
ACTH NORMAL RANGE (K842249)Diagnostic Systems Laboratories, Inc.1984-08-15
PATIENT BREATHING CIRCUIT (K843036)Infrasonics Corp.1984-08-15
QUAZAR ESOPHAGEAL STETHOSCOPE (K841574)Axiom Medical, Inc.1984-08-15
ACA BARBITURATES SCREEN/BENZODIAZEPIN (K842386)E.I. Dupont DE Nemours & Co., Inc.1984-08-15
SUNBED (K842787)Sun Health Systems1984-08-15
MED. 199 CATALOG M3769 W/EARLE'S SALT (K843043)Sigma Chemical Co.1984-08-14
HEMOCLIP LIGATING CLIPS MED/SML (K841547)Edward Weck, Inc.1984-08-14
VIVONEX TUNG STEN TIP TUBE (K842841)Norwich Eaton Pharmaceuticals, Inc.1984-08-14
HEMOCLIP LIGATING CLIPS M/LARGE (K841548)Edward Weck, Inc.1984-08-14
ULTRASONIC COOL SPRAY HUMIDIFIER (K842275)Sunbeam Corp.1984-08-14
HOOK PUNCH FORCEPS FOR ARTHROSCOPY (K842819)Medtech Industries, Inc.1984-08-14
HEMOCLIP AUTOMATIC CLIPS MEDIUM (K841549)Edward Weck, Inc.1984-08-14
FIRST RESPONSE EMERG. MEDICSL - BURNS (K841898)Reed Products, Inc.1984-08-14
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Every clearance here is in the API, with alerts when new ones post.