Atlas FDA

1984

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

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RecordFirmDate
ASTRA SYSTEMS AMYLASE REAGENT KIT (K843529)Beckman Instruments, Inc.1984-10-11
DIAGEM DIGITAL BLOOD GLUCOSE MONITOR (K841648)Forward Medical Supplies1984-10-11
PROVIDER BAG SPIKE W/12 MICROBORE EXTEN (K843463)Pancretec, Inc.1984-10-11
C-TERMINAL/MID-MOLECULE PARATHYROID - (K843685)Nichols Institute Diagnostics1984-10-11
GREEN CROSS URINARY DRAINAGE BAG (K843117)Tech-Cons Ltd., Intl.1984-10-11
RENIN RADIOIMMUNOASSAY TEST KIT (K842966)Serono Diagnostics, Inc.1984-10-11
GAUDERER GASTROSTOMY BUTTON (K843392)American V. Mueller1984-10-11
DK*300 VOLUMETRIC INFUSION CONTROLLER (K843254)Deka Research & Development Corp.1984-10-11
TUGS-TRANSPORTABLE UNIV. GRADIENT SUCT (K843081)Creative Medical Laboratories, Inc.1984-10-11
BIOTIS MYCOLOGICAL MEDIA & SLANT (K843766)Otisville Biotech, Inc.1984-10-10
BIOTIS EMB AGAR HOLT-HARRIS (K843763)Otisville Biotech, Inc.1984-10-10
BIOTIS SCHAEDLER AGAR & BROTH (K843764)Otisville Biotech, Inc.1984-10-10
BIOTIS EMB-LEVINE AGAR (K843762)Otisville Biotech, Inc.1984-10-10
BIOTIS KLIGLER IRON AGAR (K843768)Otisville Biotech, Inc.1984-10-10
ECONO MATE (K843715)Mountain Medical Equipment, Inc.1984-10-10
INFANT MONITOR 16900 (K843546)Healthdyne, Inc.1984-10-10
BIOTIS SEVEN H 11 AGAR (K843771)Otisville Biotech, Inc.1984-10-10
MICROPENCIL (K842596)Surgical Safety1984-10-10
BIOTIS LOWENSTEIN-JENSEN MEDIA (K843769)Otisville Biotech, Inc.1984-10-10
BIOTIS MYCOBIOTIC AGAR (K843765)Otisville Biotech, Inc.1984-10-10
BIOTIS LYSINE IRON AGAR (K843770)Otisville Biotech, Inc.1984-10-10
BIOTIS UREA AGAR (K843767)Otisville Biotech, Inc.1984-10-10
BIOTIS BIGGY AGAR & BIGGY SLANT (K843761)Otisville Biotech, Inc.1984-10-10
MICROELECTRODE (K842595)Surgical Safety1984-10-10
BIOTIS MARTIN LEWIS AGAR (K843817)Otisville Biotech, Inc.1984-10-10
48 HOUR SET CHANGES (K842399)Tri-Med, Inc.1984-10-09
I.V. TRANSFER SPIKE (K842678)Lyphomed, Inc.1984-10-09
MED. SUPPORT STOCKING-VENOFIT LASTOFLEX (K842708)Kundt + Co. AG1984-10-09
MASTER-CHEK BOWIE-DICK TYPE TEST (K843182)Arvey Corp.1984-10-09
VISITEC FLIERINGA-LEGRAND FIXATION RING (K843195)Visitec Co.1984-10-05
EMIT D.A.U. COCAINE ASSAY (K843556)Syva Co.1984-10-05
VISITEC EYE SPECULUM (K843196)Visitec Co.1984-10-05
VISITEC EYE SHIELD (K843197)Visitec Co.1984-10-05
CILCO DIAMOND KNIFE (K843447)Cilco, Inc.1984-10-05
LIQUID CHROMATOGRAPHY COLUMNS;ION EXCH (K842909)Supelco, Inc.1984-10-05
CANON AUTOREF R-10 (K841861)Canon USA, Inc.1984-10-05
AMER. SURGICAL CORP. EXTRA PLUS PAK (K841738)American Surgical Co., Inc.1984-10-05
SANITARY PANTY W/PADS & DESIGNED (K843015)Hygienics Industries, Inc.1984-10-05
TRIA LENS SET (K843095)Optek Medico Co., Ltd.1984-10-05
STANDARDS & ACCESSORIES FOR NOVA INSTRU (K842873)Diagnostic Chemicals, Ltd. (Usa)1984-10-05
CANON 60 FUNDUS CAMERA CF-60U (K843021)Canon USA, Inc.1984-10-05
HUMAN SERUM CARDIOACTIVE DRUG CONTROL (K843679)Quantimetrix Corp.1984-10-05
BOEHRINGER MANNHEIM DIAGNOSTICS ADAM (K843283)Boehringer Mannheim Corp.1984-10-05
SCLAVO CHLORIDE TEST (K843740)Sclavo, Inc.1984-10-05
ROCHE REAGENT FOR ALT (K843111)Roche Diagnostic Systems, Inc.1984-10-05
VICO MICRO SURGICAL INSTRUMENTS (K843592)Visitec Co.1984-10-05
CATAREX VITRECUTTER I/A DISPOS. CUT (K840063)Calliope Corp.1984-10-05
VISION TESTER (K843042)Stereo Optical Co., Inc.1984-10-05
FRAME SPECTACLE (K843123)Vision Industries Corp.1984-10-05
ISO-DATA CENTRIFUGES 1-A, 101, 2D, ETC. (K843434)Iso-Data, Inc.1984-10-05
PERSPECTIVE CHEMICAL ANALYZER (K843610)American Monitor Corp.1984-10-05
BREATHABLE MINI-SHIELD-PRIVATE LABEL (K843602)I.C.D. Industries, Inc.1984-10-05
EMIT 700 METHAQUALONE ASSAY (K843605)Syva Co.1984-10-05
MICROSCOPE MITTS SUPPORT TRAY COVER (K842859)Chiron Vision Corp.1984-10-05
RING SUPPORTED TREPHINE FOR CORNEA TRANS (K843048)Precision Instruments, Inc.1984-10-05
RIANEN ANIT-DOUBLE STRANDED DEOXYRIBON (K843347)E.I. Dupont DE Nemours & Co., Inc.1984-10-05
SAFE & SOFT PANTY SHIELDS (K842838)Ipco Corp.1984-10-05
NIDEK DIGITAL KERATOMETER (K842892)Nidek, Inc.1984-10-05
CONCEPT FIBER OPTIC CANALICULUS INTUBA (K843491)Concept, Inc.1984-10-05
EMIT 700 CANNABINOID CONTROL SET (K843419)Syva Co.1984-10-05
KOVA TROL I,II, III HUMAN URINE-DRIED (K843565)Icl Scientific1984-10-05
ORTHO* RSV ANTIGEN ELISA TEST SYS (K842047)Ortho Diagnostic Systems, Inc.1984-10-05
FIAX HAPTOGLOBIN TEST KIT (K843570)Intl. Diagnostic Technology1984-10-05
ULTRAMARK 4 ULTRASOUND SYS (K842376)Advanced Technology Laboratories, Inc.1984-10-05
CORNING IMMUNOFIXATION SYS (K843614)Corning Medical & Scientific1984-10-05
CORNEAL LIGHT SHIELD (K840834)Gabl, Inc.1984-10-05
CATAREX/ULTRASONICS KIT (K840181)Calliope Corp.1984-10-05
MAXI-MISER HUMIDIFIER INSERT 1030 (K842795)Nova-Ventrx1984-10-04
ELECTRO-NERVE STIMULATOR HL (K841184)Biomedical Life Systems, Inc.1984-10-04
TUBE-STAT (K843490)Concept, Inc.1984-10-04
MEDIFLEX DRAINAGE BAG (K843126)Mediflex Intl.1984-10-04
BUNN 3001 OXYGEN CONCENTRATOR (K843811)The John Bunn Co.1984-10-04
CURITY SILICONE NEPHROSTOMY CATHETER (K842840)The Kendal Co.1984-10-04
LINDER NASOPHARYNGEAL AIRWAY (K843524)Polamedco, Inc.1984-10-04
SEXTON CYSTOTOMY URINE PUMP (K843158)Holter-Hausner Intl.1984-10-04
BALLOON DILATION CATHETER (K843501)Advanced Cardiovascular Systems, Inc.1984-10-04
WAREXIN RECOMMENDED ALTERNATIVE DIALYZ (K843520)Mesa Medical, Inc.1984-10-04
COTTON TIPPED APPLICATORS, SINGLE (K843720)Abco Dealers, Inc.1984-10-04
ENCORE HCG REAGENT (K843407)Hybritech, Inc.1984-10-04
PNEUPAC INSTANT ACTION VENTILATOR/RESUS (K843737)Pneupac , Ltd.1984-10-04
OHMEDA MODEL 5200 CO2 MONITOR (K843599)Ohmeda Medical1984-10-04
SPACELABS ICR ARRHYTHMIA MASTER I HOLTER (K842640)Spacelabs, Inc.1984-10-04
NEW ALLERG. COATED MICROFILTER WELL STRI (K843302)Diagnostic Reagent Tech.1984-10-04
OHMEDA RM311 RESPIROMETER (K843799)Ohmeda Medical1984-10-04
SERVOMED OXYMONITO SMK 363 (K842497)Litton Datamedix1984-10-04
VIDEO URODYNAMICS SYS 1906B-Y & 1906C-Y (K843198)Life-Tech Intl., Inc.1984-10-04
MAXI-MISER HUMIDIFIER INSERT 1020 & 1021 (K842794)Nova-Ventrx1984-10-04
OHMEDA RM121 RESPIROMETER (K843800)Ohmeda Medical1984-10-04
GUIDELINES FOR PEDIATRIC ANESTHESIA (K842610)Critical Care Micro Computing1984-10-04
MODELS 78551A 78552A (K841256)Hewlett-Packard Co.1984-10-02
DILATOR/SHEATH SET (K842632)American Edwards Laboratories1984-10-02
48 HOUR BIOLOGICAL INDICATORS SPORSTRIP (K841709)Skyland Scientific Services, Inc.1984-10-02
NEOMYCIN BLOOD AGAR (K843492)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-10-02
ND-YAG LASER FOR UROLOGICAL SURGERY (K843293)Endo Lase, Inc.1984-10-02
AMER. EDWARDS LAB DIAFLEX URETERAL DILA (K842639)American Edwards Laboratories1984-10-02
CATH-TECH CHOLANGIOGRAPHY CATHETER (K842147)Catheter Technology Corp.1984-10-02
GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6 (K843427)Accra Laboratories, Inc.1984-10-02
HEART RATE/RESPIRATION SIMULATOR 8310 (K841363)Aequitron Medical, Inc.1984-10-02
HARRIS HEMATOXYLIN, MERCURY FREE, ACID (K843425)Accra Laboratories, Inc.1984-10-02
HEMODIAL CONCENTRATE MIXING APPARATUS (K842225)Lmf Medical Research & Manufacturing, Inc.1984-10-02
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Track 1984 automatically

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