Atlas FDA

1984

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

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RecordFirmDate
ELVI 675 DIGITRON (K843296)Logos Scientific, Inc.1984-09-13
ROCHE STANDARDS FOR URIC ACID (K843112)Roche Diagnostic Systems, Inc.1984-09-13
JINOTTI OXYGEN/SUCTION CATHETER (K841425)Research Medical, Inc.1984-09-13
SYSTEMATE 2GT - 67207 (K843268)Em Diagnostic Systems, Inc.1984-09-13
SYSTEMATE ALKALINE PHOSPHATASE-67203 (K843270)Em Diagnostic Systems, Inc.1984-09-13
SYSTEMATE URIC ACID, HEM 67220 (K843325)Em Diagnostic Systems, Inc.1984-09-13
DEKA SOLUTION ADMIN. SET DK 302-A (K843054)Deka Research & Development Corp.1984-09-13
AXIOM STABLE II TRIGLYCERIDES TEST (K842443)Axiom, Inc.1984-09-13
CENTURIAN HYDRAULIC STRETCHER (K843439)American Sterilizer Co.1984-09-13
INFANT APNEA BED STIMULATOR AA-010 (K842607)Alpha Medical Systems1984-09-13
SYSTEMATE LDH, 67210 (K843269)Em Diagnostic Systems, Inc.1984-09-13
ID ZINE LD ISOENZYME CONTROL ABNORM (K843265)Beckman Instruments, Inc.1984-09-13
RADIONICS MINI & STANDARD SHUNT VALVE (K843132)Radionics, Inc.1984-09-12
PATIENT GUIDED KNEE EXERCISER (K843493)Richards Medical Co., Inc.1984-09-12
ACETIC ACID 2% V/V (K842937)E K Ind., Inc.1984-09-12
CAPILLARY FLOW DIALYZERS (K840937)Travenol Laboratories, S.A.1984-09-12
PM 2000 DENTAL UNIT (K842357)Planmeca USA, Inc.1984-09-12
SUCROSEP THYROID STIMULATING HORMONE (K842593)Boots-Celltech Diagnostics, Inc.1984-09-12
STRATUS QUINIDINE FLUOROMETRIC ENZYME (K843237)American Dade1984-09-12
ACETIC ACID, 3% V/V (K842936)E K Ind., Inc.1984-09-12
HASTINGS BIPOLAR ENDOPROSTHESIS (K842344)Johnson & Johnson Professionals, Inc.1984-09-12
EMIT 700 CALIBRATOR A (K843163)Syva Co.1984-09-12
DECOLORIZING FLUIC, ACID-ALCOHOL 3% (K842934)E K Ind., Inc.1984-09-12
BRITISH SPINAL FUSION SET (K842698)Downs Surgical , Ltd.1984-09-12
OXALATE URINE CONTROLS NORMAL & ELEVAT (K842366)Sigma Chemical Co.1984-09-12
APPLELISA CHLAMYDIA TRACHOMATIS ANTI (K843120)Apple Diagnostic Products1984-09-12
ACETIC ACID, 5% V/V (K842935)E K Ind., Inc.1984-09-12
AMIKACIN ANALYTICAL TEST PACK ACA (K843211)E.I. Dupont DE Nemours & Co., Inc.1984-09-12
HEMOPERFUSION PROCEDURE W/REDY 2000 (K842513)Organon Teknika Corp.1984-09-12
RADIOMETRIC BLOOD CULTURE VIALS, AEROBE (K842874)American Micro Scan1984-09-12
BASILDON-GARDNER SPINAL FRAME (K842700)Downs Surgical , Ltd.1984-09-12
KAPP SPINAL BUTTON (K843368)Kapp Surgical Instrument, Inc.1984-09-12
DIFFERENTIAL DIAG. OCCLUSAL APPLIANCE (K842788)Brimms, Inc.1984-09-11
FORMALIN-ACETO-ALCOHOL FIXATIVE (K842731)E K Ind., Inc.1984-09-11
AXIPAC II (K834539)Teknar, Inc.1984-09-11
LIGHT GREEN SF 1% (K842927)E K Ind., Inc.1984-09-11
PAP STAIN EA-65 (K842735)E K Ind., Inc.1984-09-11
SUDAN IV HERXHEIMER (K842916)E K Ind., Inc.1984-09-11
PAP STAIN, EA-36 (K842739)E K Ind., Inc.1984-09-11
ACUFEX ARTHROSCOPE (K843208)Acufex Microsurgical, Inc.1984-09-11
INDOLE SPOT TEST KIT 270-25 (K843316)Applied Polytechnology, Inc.1984-09-11
MUCI-CARMINE STAIN, MAYER'S FORMULA (K842925)E K Ind., Inc.1984-09-11
CARBOL-FUCHSIN, ZIEHL-NEEDSEN (K842933)E K Ind., Inc.1984-09-11
METHYLENE BLUE STAIN, LOEFFLER (K842926)E K Ind., Inc.1984-09-11
HOLTER SCREENING MONITOR HS-221 (K842462)Advantage Medical Systems, Inc.1984-09-11
FLUID ADMINISTRATION LINE W/SPIKE 14-923 (K842858)Norton Performance Plastics Corp.1984-09-11
PICRIC ACID 1% W/V (K842923)E K Ind., Inc.1984-09-11
SCHIFF REAGENT FUCHSIN-SULFUROUS ACID (K842919)E K Ind., Inc.1984-09-11
SCOTTS TAP WATER SUBSTITUTE (K842918)E K Ind., Inc.1984-09-11
STAIN, METHYLENE BLUE-EOSIN (K842785)Reagent Laboratory, Inc.1984-09-11
JENNER BLOOD STAIN (K842928)E K Ind., Inc.1984-09-11
DIA T1, T2 & T3 (K842286)Diatech, Inc.1984-09-11
BUFFERED SALINE (K842722)E K Ind., Inc.1984-09-11
GIARDIA GUARD (K842052)Gelman Sciences, Inc.1984-09-11
ANGIOSYSTEMS STANDARD ARTERIOGRAM & CARD (K843261)Angiosystems, Inc.1984-09-11
SABA-COOMBS MINI EXTERNAL FIXATOR (K842343)Zimmer, Inc.1984-09-11
FUKUDA DENSHI FX-302 AUTO/THREE CHAN (K833594)Brentwood Instruments, Inc.1984-09-11
GRAM STAIN (K843050)Reagent Laboratory, Inc.1984-09-11
GOMORI'S TRICHROME STAIN (K842930)E K Ind., Inc.1984-09-11
CURITY SUPRAPUBIC DRAINAGE SYSTEM (K842899)The Kendal Co.1984-09-10
OSTOMY OR UROSTOMY ABDOMINAL BELT OS (K842119)Atlas Surgical Belt Co., Inc.1984-09-10
URETHRAL CATHETERIZATION TRAY (K842866)Inmed Corp.1984-09-10
PROTOMED/TOWIC NASOGASTRIC TUBE DRAINAGE BAG (K841986)Protomed Corp.1984-09-10
FORMACLEAR- & MULTIPLE (K842131)Rna Medical Corp.1984-09-10
AIMED FOLEY CATHETER VARIOUS SIZES (K842228)Tech-Cons Ltd., Intl.1984-09-10
ELVI 146 SEROSCAN (K842313)Logos Scientific, Inc.1984-09-10
SICKLING HEMOGLOBIN CONTROLS, NORMAL (K842152)Isolab, Inc.1984-09-09
SALICYLATE TEST (K843180)Sclavo, Inc.1984-09-07
CARDI-CK EIA TEST KIT CK-MB ISOENZYME (K843007)Intl. Immunoassay Laboratories, Inc.1984-09-07
TOTAL BILIRUBIN TEST (K843178)Sclavo, Inc.1984-09-07
REES & ECKER DILUTION FLUID (K842921)E K Ind., Inc.1984-09-07
DIATROL BLOOD GLUCOSE TEST SYS (K842684)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-09-07
AMIZYME-TOXOPLASMA GONDII KIT (K842528)Amico Lab, Inc.1984-09-07
CMV LATEX AGGLUTINATION TEST KIT (K841520)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-09-07
TOP HYPODERMIC SYRINGE PISTON (K843414)Top Surgical Manufacturers Co.1984-09-07
SCHIFF REAGENT, PAS STAIN (K842917)E K Ind., Inc.1984-09-07
MOBILE OPERATING TABLE HEIDELBERGS 1130 (K843134)Stierlen-Maquet AG1984-09-07
WRIGHT STAIN FIXATIVE (K842913)E K Ind., Inc.1984-09-07
TERUMO SENSIBEAD EIA THYROID UPTAKE KIT (K842694)Terumo Medical Corp.1984-09-07
MOLINEA UNDERPADS (K843402)Paul Hartmann Corp.1984-09-07
CODE-A-WELL 350 MICROTITRATION STRIPS (K842848)Plastic Injectors, Inc.1984-09-07
T-TYPE IV EXTENSION SET (K843249)Strato Medical Corp.1984-09-07
APCO FISSURE SEALER & BONDING AGENT (K843098)Scientific Pharmaceuticals, Inc.1984-09-07
CARNOY'S SOLUTION (K842737)E K Ind., Inc.1984-09-07
AUGMENTIN 30 MCG SENSITIVITY DISKS (K843172)Difco Laboratories, Inc.1984-09-07
EVER-BOND V GLASS LONOMER RESTORATIVE (K843072)Kerr Corporation (Danbury)1984-09-07
HOME NUTRIBAG MIXING CONTAINER 1000ML (K842628)Medical & Pharmaceutical Supplies, Inc.1984-09-07
ORANGE G, 1% (K842924)E K Ind., Inc.1984-09-07
AMERICAN MEDICAL OPTICS IMAGING SYS (K842127)American Medical Optics1984-09-07
HAYEM DILUTING FLUID (K842929)E K Ind., Inc.1984-09-07
PICRIC ACID SATURATED SOLUTION (K842922)E K Ind., Inc.1984-09-07
K-BASS LO FREQUENCY HEARING AID (K843144)Etymotic Research1984-09-07
ALBUMIN ASSAY KIT (K843104)Diagnostic Chemicals, Ltd. (Usa)1984-09-07
STERILE SOLUTION BOWL (K843115)E.M. Adams1984-09-07
WRIGHT STAIN BUFFER (K842914)E K Ind., Inc.1984-09-07
RADIOEAR M430 PP (K841934)Radioear Corp.1984-09-07
GUIDE TO THE KNEE (K843121)Dyonics, Inc.1984-09-07
ACA BARBITURATES SCREEN ANALY TEST PACK (K842783)E.I. Dupont DE Nemours & Co., Inc.1984-09-07
DIFFERENTIATION DISKS BILE ESCULIN (K843364)Difco Laboratories, Inc.1984-09-07
CREATININE TEST (K843179)Sclavo, Inc.1984-09-07
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Track 1984 automatically

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