Atlas FDA

1984

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

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RecordFirmDate
FLO-GARD 4000 VOLUMETRIC INFUSION (K840644)Travenol Laboratories, S.A.1984-03-23
COAT-A-COUNT ESTRADIOL KIT (K840051)Diagnostic Products Corp.1984-03-23
HEMOGLOBIN REAGENT SET (K841057)Medical Specialties, Inc.1984-03-23
MOBILIZER (K840551)Lossing Orthopedic, Inc.1984-03-23
EILE-ESCULIN AZIDE AGAR (K841132)Anaerobe Systems1984-03-23
MAGIC 125I DIGOXIN RADIOIMMUNOASSAY (K840461)Corning Medical & Scientific1984-03-23
HARRINGTON-TYPE INSTRU-SCOLIOSIS (K840423)Link America, Inc.1984-03-23
TRIGLYCERIDE/CHOLESTEROL AQUEOUS (K840219)Preventive Diagnostics Corp.1984-03-23
NEISSERIA MENINGITIDIS GR. A (K840510)Scientific Device Laboratory, Inc.1984-03-23
TRYPTICASE SOY AGAR W/5% SHEEP BLOOD (K841130)Anaerobe Systems1984-03-23
DIFFERENTIATION DISKS ALA (K840896)Difco Laboratories, Inc.1984-03-23
BLOOD CONCENTRATOR 140 (K840543)Gambro, Inc.1984-03-23
KINETIC LDH, A< BLUE 610 METHOD (K840006)American Monitor Corp.1984-03-23
DETERMIN. OF SALICYLATE IN SERUM/PLAST (K840243)Sigma Chemical Co.1984-03-23
MICRODASE (K840819)Remel Co.1984-03-23
MICROMEDIC LH & FSH RIA KIT (K840188)Micromedic Systems1984-03-23
TOTAL CHOLESTEROL REAGENT SET (K840189)Preventive Diagnostics Corp.1984-03-23
OHIO 3000 INFANT WARMER SYSTEM (K840857)Ohio Medical Products1984-03-23
AMICON DIAFILTER 40. HEMOFILTER (K840449)Medical Device Consultants, Inc.1984-03-23
FSH QUIK RIA KIT (K840230)Pacific Biotech, Inc.1984-03-23
STREPTOCOCCUS GR. D (K840511)Scientific Device Laboratory, Inc.1984-03-23
TOBRAMYCIN REAGENT (K832763)Biosan Laboratories, Inc.1984-03-23
ELECTRODE PLACEMENT SLEEVE (K840591)Bio-Stimu Trend Corp.1984-03-23
TISSUE CULTURE REFEEDING MEDIUM (K834113)Bartels Immunodiagnostic Supplies, Inc.1984-03-23
ELECTRODE PLACEMENT LUMBAR SHORTS (K840592)Bio-Stimu Trend Corp.1984-03-23
CSPI PREMIUM SURGICAL ASPIRATOR (K841242)Custom Surgical Products, Inc.1984-03-23
EMIT ST SERUM ETHYL ALCOHOL ASSAY (K840400)Syva Co.1984-03-23
PROTECTA COAT SPONGES (K840156)Alimed, Inc.1984-03-23
NEISSERIA MENINGITIDIS CONTROL (K840514)Scientific Device Laboratory, Inc.1984-03-23
CULTROL-ANTIBIOTIC/ANTIMYCOTIC SOLUT (K834115)Bartels Immunodiagnostic Supplies, Inc.1984-03-23
ACE COLOR TEST (K833933)Hana Biologics, Inc.1984-03-23
PRESERV BUFFERED GLYCEROL SALINE (K840991)Preventive Diagnostics Corp.1984-03-23
CHEM-STAT ANALYZER (K840340)Ocean Scientific, Inc.1984-03-23
XYLOSE LYSINE DESOXYCHOLATE AGAR (K841131)Anaerobe Systems1984-03-23
FLUSH SOLUTION CONCENTRATE-BLOOD GAS (K840300)Bionostics, Inc.1984-03-23
ECHO MM1000 (K834447)Mesa Medical, Inc.1984-03-23
STREPTOCOCCUS PNEUMONIAE CONTROL (K840512)Scientific Device Laboratory, Inc.1984-03-23
NEISSERIA MENINGITIDIS GR. C (K840508)Scientific Device Laboratory, Inc.1984-03-23
TREONIC C30 (K840823)Vickers America Medical Corp.1984-03-23
UROLIX-3 UROLOGICAL TABLE (K840227)Medicor USA , Ltd.1984-03-23
PHOTO-THERAPY EYE PROTECTOR (K840894)A & A Medical Supplies Co.1984-03-23
CRISA (K840135)X-Ray Tube Corp.1984-03-23
UNI-FAST ANALYZER SYSTEM (K840129)Sclavo, Inc.1984-03-23
ADVANTAGE (K840120)Gilford1984-03-23
PRESERV TRANSPORT & CULTURE PACK (K840968)Preventive Diagnostics Corp.1984-03-23
PBC SYRINGE IRRIGATING (K834256)Philadelphia Biologics Center1984-03-23
OHIO 3300 INFANT WARMER SYSTEM (K840858)Ohio Medical Products1984-03-23
CRP SLIDE TEST KIT (K840699)Difco Laboratories, Inc.1984-03-23
CLOSTRIDIUM DIFFICILE AGAR DEEP & (K840889)Remel Co.1984-03-23
ORTHO BI-LEVEL RECEPTOR CONTROL (K834064)Ortho Diagnostic Systems, Inc.1984-03-23
OHIO HEAT REFLECTING PATCH (K840967)Ohio Medical Products1984-03-23
PRESERV CARY BLAIR TRANSPORT PACK (K840990)Preventive Diagnostics Corp.1984-03-23
STREPTOCOCCUS GR. B CONTROL (K840513)Scientific Device Laboratory, Inc.1984-03-23
QUINIDINE CALIBRATOR (K840597)E.I. Dupont DE Nemours & Co., Inc.1984-03-23
PBS W/MG+2 & CA+2 (K834136)Bartels Immunodiagnostic Supplies, Inc.1984-03-22
EMIT ST SERUM PHENCYCLIDINE ASSAY (K840199)Syva Co.1984-03-22
MCCOY CELLS (K834119)Bartels Immunodiagnostic Supplies, Inc.1984-03-22
BSM 2000 DIALYSIS MACHINE (K840062)Organon Teknika Corp.1984-03-22
SECURE W/35MM DIAM, SHEATH/ADHESIVE (K840704)Warne Surgical Products, Ltd.1984-03-22
VERO CELLS (K834124)Bartels Immunodiagnostic Supplies, Inc.1984-03-22
SECURE W/30MM DIAM, SHEATH & ADHESIVE (K840703)Warne Surgical Products, Ltd.1984-03-22
WEE BAG O'MERCURY (K840004)Surgi-Quip Inc.U1984-03-22
CARDIAC OUTPUT SIGNAL ACQUISTION (K833914)Hewlett-Packard Co.1984-03-22
JAKOBI SURGICAL INSTRUMENTS #3 17/18/19 (K834191)Imm Enterprises , Ltd.1984-03-22
DISPOSABLE CUVETTE ARRAY (K840231)Consumable Lab Supplies1984-03-22
SECURE W/25MM DIAM. SHEATH & ADHESIVE (K840702)Warne Surgical Products, Ltd.1984-03-22
SEVOMED COMPACT MONITOR SMK 154- (K832095)Litton Medical Electronics1984-03-22
SERVOMED COMPACT MONITOR SMK 155-7/101 (K832025)Litton Medical Electronics1984-03-22
SERENITY CONTOURED ABSORBENT SHIELDS (K840679)Johnson & Johnson Consumer Products, Inc.1984-03-22
NEEDLE CATHETER JEJUNOSTOMY REPAIR KIT (K840936)Biosearch Medical Products, Inc.1984-03-22
MODEL TTPM TIME TEMP. PRESSURE MONITOR (K832897)Electromedics, Inc.1984-03-22
C-ARM CEILING CRANE FT-2 (K840225)Medicor USA , Ltd.1984-03-22
DIGITAL PROCESSING SYSTEM (K840052)Adac Laboratories1984-03-22
MRC-5 CELLS (K834126)Bartels Immunodiagnostic Supplies, Inc.1984-03-22
BILIARY INDWELLING STENT (K834351)Hobbs Medical, Inc.1984-03-22
LLC-MK2-RHESUS MONKEY KIDNEY CELLS (K834120)Bartels Immunodiagnostic Supplies, Inc.1984-03-22
HEMODYNAMIC PLUG-IN MODULE 78551A (K833913)Hewlett-Packard Co.1984-03-22
DESERET INFANT CENTRAL VENOUS CATHE- (K840116)Parke-Davis Co.1984-03-22
PATIENT MONITOR #404 (K831319)Analogic Corp.1984-03-22
URETERAL DOUBLE PIGTAIL STENT (K834401)Hobbs Medical, Inc.1984-03-22
EMIT ST URINE METHAQUALONE ASSAY (K840164)Syva Co.1984-03-22
WI-38 HUMAN LUNG CELLS (K834123)Bartels Immunodiagnostic Supplies, Inc.1984-03-22
JAKOBI SURG. INSTRUMENTS #3 21/22/24 (K834192)Imm Enterprises , Ltd.1984-03-22
SPEECH TEACHER (K840112)Joseph A. Resnick1984-03-22
EKTACHEM CLINICAL CHEM. SLIDES (K840151)Eastman Kodak Company1984-03-22
HUMAN FIBROBLASTIC CELLS-HUMAN NEWBORN (K834117)Bartels Immunodiagnostic Supplies, Inc.1984-03-22
3-DAY BIOINDICATOR RELEASE FOR STERIL (K833831)Shiley, Inc.1984-03-21
HEMO-KART (K841179)Micro Encapsulation Tech.1984-03-20
PROBES, VARIOUS (K841003)Premier Dental Products Co.1984-03-20
ALU-KART (K841178)Micro Encapsulation Tech.1984-03-20
DIA-KART (K841180)Micro Encapsulation Tech.1984-03-20
STERILE DISPOSABLE SPINAL NEEDLES (K834407)Hydro-Med Products, Inc.1984-03-19
EMIT ST URINE ETHYL ALCOHOL ASSAY (K840171)Syva Co.1984-03-19
CONTROL COVER GOWN (K840229)Kimberly-Clark Corp.1984-03-19
CURIETRON (K840127)Syncor Intl. Corp.1984-03-19
PLAYTEX SLENDER REGULAR TAMPONS (K841154)Playtex, Inc.1984-03-19
SANI CATCH BA (K833814)Concord Laboratories, Inc.1984-03-19
MODIFIED HPS HIP PROSTHESIS (K833599)Depuy, Inc.1984-03-19
VERIFY PREGNANCY TEST KIT (K840602)O.T.C. Diagnostics, Inc.1984-03-19
EMIT ST SERUM BARBITURATE ASSAY (K840194)Syva Co.1984-03-19
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Every clearance here is in the API, with alerts when new ones post.