Atlas FDA

1981

3,287 FDA 510(k) clearances · Clearance year

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RecordFirmDate
KALLESTAD ANTISERA TO TOBRAMYCIN (K812415)Kallestad Laboratories, Inc.1981-09-09
UNSCENTED MENSTRUAL PADS (K812402)Procter & Gamble Mfg. Co.1981-09-09
PLEURAL DRAINAGE SYSTEM #PDS-4300 (K812224)Bentley Laboratories, Inc.1981-09-09
GOLD(AU 195) GAMMA CAMERA CHECK(FLOOD) (K812236)Amersham Corp.1981-09-09
DIGITRON ELECTRONIC THERMOMETERS - 4700 (K812387)Ercona Corp.1981-09-09
GUINEA PIG BLOOD IN ALSEVER'S, CIT., DEF (K812372)Dutchland Laboratories, Inc.1981-09-09
GOLD(AU 195) SPOT MARKER SOURCES (K812235)Amersham Corp.1981-09-09
BLOOD UREA NITROGEN(BUN-UV) (K812417)Reagents Applications, Inc.1981-09-09
BUTTERFLY NEEDLE ASSEMBLY (K812404)Nu Tech Medical Systems1981-09-09
CORDISNHYPERION HEMOGLOBIN A1 TEST SYS (K812242)Cordis Corp.1981-09-09
TERUFUSION INFUSION PUMP MODEL STC-502 (K812339)Terumo Medical Corp.1981-09-09
URIC ACID REAGENT SET (K812430)Pointe Scientific, Inc.,1981-09-09
PRISMA-FIL COMPULES (K812277)Caulk Co., Div. Dentsply1981-09-08
NEWBORN CALF SERUM - STERILE (K812384)Dutchland Laboratories, Inc.1981-09-08
PROPOSED CONTROLS FOR DOSIMETRIC RELEASE (K812068)Hexcel Medical1981-09-08
DYNA- MO (K811629)Philips Medical Systems (Cleveland), Inc.1981-09-08
LEGIONELLA INDIRECT FLUOR. ANTIBODY (K812007)Centers for Disease Control and Prevention1981-09-08
NATAL CALF (BOVINE) SERUM - STERILE (K812385)Dutchland Laboratories, Inc.1981-09-08
MEDISYSTEMS FISTULA NEEDLE (K811838)Medisystems Corp.1981-09-08
LEGIONELLA DIRECT FLUORESCENT ANTIBODY (K812006)Centers for Disease Control and Prevention1981-09-08
HEMOLYSIN (K812371)Dutchland Laboratories, Inc.1981-09-08
DONOR HORSE SERUM - STERILE (K812381)Dutchland Laboratories, Inc.1981-09-08
NOVAMETRIX PHYSIOLOGICAL MONITOR #910 (K811893)Novametrix Medical Systems, Inc.1981-09-08
GUINEA PIG COMPLEMENT REGULAR (K812370)Dutchland Laboratories, Inc.1981-09-08
CYCLES REUSABLE MENSTRUAL PADS (K812333)Cycles1981-09-08
GINGI-PLAIN CORDS & BRAIDS (K812120)Belport Co., Inc.1981-09-08
PHOTOLITE AOLITE TINTOMATIC LENS (K812051)American Optical Corp.1981-09-08
CASTLE TEC-TEST BIOLOGICAL INDICATOR (K812272)Sybron Corp.1981-09-08
J & S IRON SATURATING REAGENT (K811942)Thyroid Diagnostics, Inc.1981-09-08
MULTI-PURPOSE DENTAL SYRINGE (K811831)Centrix, Inc.1981-09-08
CALF (BOVINE) SERUM - STERILE (K812383)Dutchland Laboratories, Inc.1981-09-08
MRI GENTAMICIN RIA KIT (K812394)Microanalytic Research, Inc.1981-09-08
UROFLOWMETER (K811925)C.R. Bard, Inc.1981-09-08
FETAL BOVINE SERUM - STERILE (K812386)Dutchland Laboratories, Inc.1981-09-08
VISIO-FIL (K812169)Espe GmbH (Us)1981-09-08
ZEE ELECTRODE-GEL (K812284)Zee Medical Products Co., Inc.1981-09-08
MODEL SIX BEAM SYSTEM (K811848)Braintech, Inc.1981-09-08
MEDISYSTEM NEGATIVE PRESSURE (K811839)Medisystems Corp.1981-09-08
SCRIPPSYSTEM NEPHELOMETRIC ANTISERA KIT (K812328)Scripps-Miles, Inc.1981-09-08
MONTG. ESOPHAGEAL -SALIVARY BYPASS- TUBE (K812305)Boston Medical Products, Inc.1981-09-08
RABBIT SERUM - STERILE (K812380)Dutchland Laboratories, Inc.1981-09-08
SCOPE MASTER (K811270)Synemed, Inc.1981-09-08
GUINEA PIG SERUM - STERILE (K812379)Dutchland Laboratories, Inc.1981-09-08
DONOR CALF (BOVINE-SERUM) - STERILE (K812382)Dutchland Laboratories, Inc.1981-09-08
SHILEY FENESTRATED LOW PRESS. CUFFED (K812302)Shiley, Inc.1981-09-08
GUINEA PIG COMPLEMENT VIRUS ANTIBODY (K812369)Dutchland Laboratories, Inc.1981-09-08
ACRIDINE ORANGE STAIN (K812212)Carr-Scarborough Microbiologicals, Inc.1981-09-01
GLUCOSE-HK SYSTEM PACK TEST (K812303)Boehringer Mannheim Corp.1981-09-01
UREA NITROGEN (BUN) (K812341)Pointe Scientific, Inc.,1981-09-01
B-NEOCEPT (K812334)Organon, Inc.1981-09-01
HELENA HBF QUIPLATE CONTROL (K812226)Helena Laboratories1981-09-01
REAGENT STRIPS FOR URINALYSIS (K811342)Miles Laboratories, Inc.1981-09-01
ZETA-SERA D (K812329)Amf Biological and Diagnostics Co.1981-09-01
GELMAN IG-FIX KIT (K812253)Gelman Sciences, Inc.1981-09-01
AURAMINE O MYCROBACTERIAL STAIN SET (K812274)Carr-Scarborough Microbiologicals, Inc.1981-09-01
VENTREX DATA REDUCTION & QUAL. CONTR. SY (K812357)Ventrex Laboratories, Inc.1981-09-01
TANDEM PAP KIT - (PARTS I & II) (K811959)Hybritech, Inc.1981-09-01
LIPO-SEP CHOLESTEROL AUDIT SYSTEM (K812318)Isolab, Inc.1981-09-01
SANDARE URIC ACID PROCEDURE (K812313)Sandare Chemical Co., Inc.1981-09-01
ANTITHROMBIN III SCREEN KIT (K812215)Pacific Hemostasis1981-09-01
CRITHIDNA ANTI-DNA TEST KIT (K812314)Antibodies, Inc.1981-09-01
KAPPA & LAMBDA BENCE JONES CONTROLS (K812327)Kallestad Laboratories, Inc.1981-09-01
CELESTIN DILATOR (K812289)Inmed Corp.1981-09-01
HERPES VIRUS HOMINIS ANTIBODY TEST SYS. (K812085)Zeus Scientific, Inc.1981-09-01
ACCURATE I (K812261)Organon, Inc.1981-08-31
CONTACT LENS CLEANER (K812172)Alcon Laboratories1981-08-31
SMITH'S SYSTEMIC FUNGAL MEDIUM (K812187)American Scientific Products1981-08-31
S-610 SHUNT ADAPTOR SET (K811851)Dravon Medical, Inc.1981-08-31
K-MED SILICONE SUMP DRAIN (K812026)K-Med, Inc.1981-08-31
PERMAGUM (K812116)Espe-Premier Sales Co.1981-08-31
LACTO-PHENOL ANILINE BLUE MOUNTING FLUID (K812192)American Scientific Products1981-08-31
CONVEEN URISHEATH & CONVEEN URILINER (K812294)Telcam Medical Devices, Inc.1981-08-31
MEDTRONIC SPECTRAX (K812153)Medtronic Vascular1981-08-31
GAMBRO LUNDIA PLATE HIGH FLUX DIALYZER (K811944)Gambro, Inc.1981-08-31
ENXYMATIC CREATININE TEST (K812095)Boehringer Mannheim Corp.1981-08-31
GAMMA GLUTAMY TRANSPEPTIDASE (K812296)Pointe Scientific, Inc.,1981-08-31
COCCIDIOIDES IMMUNODIFFUSION SYSTEM (K812190)American Scientific Products1981-08-31
NIMETIC-DISPERS (K812119)Espe-Premier Sales Co.1981-08-31
CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI (K812188)American Scientific Products1981-08-31
THE AMP 80/2 PEDIATRIC CYCLER SYSTEM (K811986)American Medical Products, Inc.1981-08-31
MODEL 78850 OXYGEN MONITOR (K812167)Hewlett-Packard Co.1981-08-31
ACR ENZYMATIC GLUCOSE OXIDASE (K812258)Harleco1981-08-31
O.N.A.T. (K812102)Latex Medical Devices, Inc.1981-08-31
LANCER BUN RATE REAGENT KIT (K812308)Sherwood Medical Co.1981-08-31
NEOLOOPS (K810890)Medical Marketing Systems1981-08-31
MICROSURGICAL BLADE (K812160)Vxtra Corp.1981-08-31
CARL ZEISS INN MYRINGOTOMY TUBE LINE (K811698)James L. Geraci & Associates, Inc.1981-08-31
CENTRICHEM CHOLESTEROL REAGENT & CALIBRA (K812293)Baker Diagnostics1981-08-31
DACRON PLEDGET SUTURE BUTTRESS (K812254)ETHICON, Inc.1981-08-31
KOH MOUNTING FLUID (K812193)American Scientific Products1981-08-31
CORDIS DUCOR PERCUT. TRANS. ANGIO. CATH. (K812168)Cordis Corp.1981-08-31
VASPAR SEALENT (K812191)American Scientific Products1981-08-31
CENTRAL STATION MONITOR (K812271)Datascope Corp.1981-08-31
POLAROID RADIOGRAPHIC FILM CASSETTE (K812089)Polaroid Corp.1981-08-31
INTRAVASCULAR CATHETER (K812159)Pioneer Viggo, Inc.1981-08-31
BARNES-HIND WEEKLY CLEANER (K812135)Barnes-Hind, Inc.1981-08-31
K-MED SILICONE SUMP DRAIN W/ SHEATH (K812025)K-Med, Inc.1981-08-31
IMMUNODIFFUSION BAND INTENSIFYING FLUID (K812194)American Scientific Products1981-08-31
BORES* DEPTH GAUGE (K812069)Santa Barbara Medco, Inc.1981-08-31
FUN-UV SYSTEM PACK TEST (K812290)Boehringer Mannheim Corp.1981-08-31
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Every clearance here is in the API, with alerts when new ones post.