Atlas FDA

1992

3,665 FDA 510(k) clearances · Clearance year

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RecordFirmDate
MARATHON 6K GENERAL-PURPOSE CENTRIFUGE (K915825)Fisher Scientific Co., LLC1992-03-11
IL TEST(TM) UREA NITROGEN (K914877)Instrumentation Laboratory CO1992-03-11
DISPOSABLE CAUTERY ABRASIVE PAD (K915064)American Medical Mfg., Inc.1992-03-11
LH GEN III SELF-TEST/CONCEIVE (K920160)Quidel Corp.1992-03-11
NEUROFAX EEG 5532 (K915096)Nihon Kohden America, Inc.1992-03-11
SYN ELISA MICRO ALBUMIN (K920216)Elias U.S.A., Inc.1992-03-11
SYSTEM 90 AND SYSTEM 90T (K913847)Datascope Corp.1992-03-11
DENTACOLOR(R) CRE-ACTIVE (K914456)Heraeus Kulzer, Inc.1992-03-11
IMPRAFLO POSTOPERATIVE AUTOTRANSFUSION DEVICE (K915577)Impra, Inc.1992-03-11
BIOMODULAR SHOULDER HUMERAL HEAD W/ IONGUARD (K915596)Biomet, Inc.1992-03-11
MILES LIPASE SERA-PAK METHOD (K920337)Heraeus Kulzer, Inc.1992-03-11
IMMULITE HLH (K920411)Cirrus Diagnostics, Inc.1992-03-11
IL TEST IMMUNOGLOBULIN M (IGM) (K920008)Instrumentation Laboratory CO1992-03-11
IL TEST DAT CAL/CONTROL SET D/E (K920419)Instrumentation Laboratory CO1992-03-11
SHARPLAN MODELS 100 SERIES C02 LASERS/ACCESSORIES (K914455)Sharplan Lasers, Inc.1992-03-11
YASARGIL ANEURYSM CLIPS, MODIFICATION (K913765)Aesculap, Inc.1992-03-11
BIPOLAR ENDOSTASIS PROBE, BEST (TM) (K915408)Medical Devices, Inc.1992-03-11
OSTEO COMPRESSION HIP SCREW (K920037)Osteo AG1992-03-11
TRACE MAGNESIUM - ARSENAZO REAGENT (K920603)Trace America, Inc.1992-03-11
ISOTYPES HUMAN IGG SUBCLASS EIA KIT (K920370)Isotypes, Inc.1992-03-11
IONGUARD TITANIUM MODULAR HEADS (K915548)Biomet, Inc.1992-03-10
RICH-MAR MODEL 510 ULTRASOUND (K915557)Rich-Mar Corp.1992-03-10
LAPAROSCOPY SCISSORS (K915544)C.R. Bard, Inc.1992-03-09
NEZHAT/DORSEY HYDRO DISSECTION PUMP & ACCESSORIES (K913944)American Surgical Instruments Corp.1992-03-09
VOYAGR SERIES OF DEFLECTABLE DIAGOSTIC EP CATHETER (K915640)Arrhythmia Technologies, Inc.1992-03-09
GYMMAN (K920099)Lumiscope Co., Inc.1992-03-09
CORDIS STRAIGHT VENTRICULAR CATHETER (K914995)Cordis Corp.1992-03-09
ASEPTIC DENTAL TECH. TOTAL TREATMENT SYSTEM (K914562)Aseptic Dental Technologies, Inc.1992-03-09
DIAGNOSTIC EP CATHETER (K915563)Arrhythmia Technologies, Inc.1992-03-09
ROOT CANAL FILLING CEMENT (K914325)Confi-Dental Products Co.1992-03-09
MER BAG (K915810)Merced Medical, Inc.1992-03-09
CHEMO PRIMING PIN(TM) (K914924)Block Medical, Inc.1992-03-06
RANGEROLLER (MODIFIED) (K920325)Excel Mobility Products, Inc.1992-03-06
MEDILENS-CS CORNEAL SHIELD (K915861)Chiron Ophthalmics1992-03-06
LAPAROSCOPIC CHOLANGIOGRAM CATHETER KIT (K915506)United States Endoscopy Group, Inc.1992-03-06
OMNITRON GYN APPLICATOR SYSTEM (K913908)Omnitron Intl., Inc.1992-03-06
VORTECH 3M NETWORK PRINTING (K914834)Vortech Data, Inc.1992-03-06
CONBIO MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM (K915497)Continuum Biomedical, Inc.1992-03-06
FLO-GARD 8000 HALF-SET (K915499)Baxter Healthcare Corp1992-03-06
MIRAGE COMPLETE KIT AND MIRAGE ABC KIT (K915511)Mirage Dental Systems1992-03-06
KONICA DIRECT DIGITIZER KD-1000 (K920558)Konica Corp.1992-03-06
HEAD COIL GEOMETRIC DISTOR SPEC FOR VISTA HPQ SYST (K920199)Philips Medical Systems (Cleveland), Inc.1992-03-06
SAECG CARDIOGRAPH MODEL M1754A (K913997)Hewlett-Packard Co.1992-03-06
JAIN BLOOD SHIELD (K913896)Jain Surgical Equipment, Inc.1992-03-06
ENDOTRACHEAL SUCTIONTUBE (K913876)Willowtech1992-03-06
GAMBRO LUNDIA ALPHA HEMODIALYZERS (K915504)C.G.H. Medical, Inc.1992-03-06
SUCTION CONTROL FOOTSWITCH WITH SPEED CONTROL (K913401)Smith & Nephew Dyonics, Inc.1992-03-06
NON-WEIGHTED POLYURETHANE ENTERAL FEEDING TUBE (K914375)Sherwood Medical Co.1992-03-06
TAMPON, UNTREATED (K912941)Hygieia Healthcare , Ltd.1992-03-06
SPECTACLE FRAMES (K920123)Po-Le Optiks1992-03-06
MOBILE MRP-7000 (K920159)Hitachi Medical Systems America, Inc.1992-03-05
ARTECH ARDENT IV - TYPE CLYLINDER IMPLANT (K911735)Artech Corp.1992-03-05
MODEL 310GE-64: WHOLE VOLUME NECK COIL (K914209)Medical Advances, Inc.1992-03-05
SINGLE USE LEE ELECTRODE (K912046)Aspen Labs1992-03-05
RUBELLA IGG ELISA TEST (K915893)Gull Laboratories, Inc.1992-03-04
VIDAS CHLAMYDIA ASSAY, MODIFICATION (K915884)Vitek Systems, Inc.1992-03-04
COAGULATION ARPR,CAT.NO.5185 (K914949)Helena Laboratories1992-03-04
FIBRINOGEN CONTROL (K915462)Sigma Diagnostics, Inc.1992-03-04
ELISA CMV IGM (K914789)Sclavo, Inc.1992-03-04
PIONEER PRO-PUMP (K914220)Pioneer Medical, Inc.1992-03-04
CLOSTRIDIUM DIFFICILE TOX-A-TEST (K914902)Techlab, Inc.1992-03-04
PERFECTA PDA TOTAL HIP SYSTEM (K915795)Orthomet, Inc.1992-03-04
OPTICAL CATHETER INTRODUCER SETS, MODIFICATION (K914315)Medical Dynamics, Inc.1992-03-04
SARNS RETROGRADE CANNULA (K915193)3M Health Care, Sarns1992-03-04
URINE A CALIBRATOR (K920208)Diagnostic Reagents, Inc.1992-03-04
NGM NIBP MODULE (K911645)Datex Division Instrumentarium Corp.1992-03-04
TOXO IGG ELISA TEST (MODIFIED) (K915891)Gull Laboratories, Inc.1992-03-04
PANCRETEC PROVIDER(R) MODEL 5500 INFUS PUMP, MODIF (K913931)Abbott Laboratories1992-03-04
PIONEER PRO-PUMP DUAL CONTROL (K914241)Pioneer Medical, Inc.1992-03-04
GEMSCOM SERIES 3000 (K914889)General Devices1992-03-04
OPTI-LENS CONTACT LENS CASE (K920064)Ryder Intl. Corp.1992-03-04
DAIG ELECTROPHYSIOLOGY CATHETER W/INFUSION LUMEN (K914278)Daig Corp.1992-03-04
ENZYGNOST TOXOPLASMOSIS/IGM (K913505)Behring Diagnostics, Inc.1992-03-04
INTRAOSSEOUS ACCESS NEEDLE (K915409)Cook, Inc.1992-03-04
FIRST CHOICE (K912580)Polymer Technology Corp.1992-03-04
MILES ASPARTATE AMINOTRANSFERASE SERA-PAK METHOD (K920336)Heraeus Kulzer, Inc.1992-03-04
GAP IGG H.PYLORI MODIFIED (K915185)Biomerica, Inc.1992-03-04
NGM FRAME (K911644)Datex Division Instrumentarium Corp.1992-03-04
MEDIX BIOTECH HGHENZYME IMMUNOASSAY TEST KIT (K920299)Medix Biotech, Inc.1992-03-04
DISPOSABLE INTROSSEOUS INFUSION NEEDLES (K913258)Cook, Inc.1992-03-04
KALLESTAD ROTAVIRUS MICROPLATE (K915137)Bio-Rad Laboratories, Inc.1992-03-04
MEDICAL SUNLAMP FOR PHOTOTHERAPY (K915426)American Sunlight, Inc.1992-03-04
BLADDERSCAN BVI 2500 (K915436)Diagnostic Ultrasound Corp.1992-03-03
VERA PDS & VERA PDI (K915249)Aalba Dent, Inc.1992-03-02
KERALLOY-D CAPS (K915654)Wilde-USA, Inc.1992-03-02
PROLENE POLYPROPYLENE MESH PLUG W/ ONLAY PATCH (K915774)ETHICON, Inc.1992-03-02
IMMOBILE (K915565)Tnt Moborg Intl. , Ltd.1992-03-02
QUICKIE P100 (K920180)Sunrise Medical Quickie Designs, Inc.1992-03-02
AUTOMIX DENTAL AMALGAMATOR (K915847)Kerr Corporation (Danbury)1992-03-02
ABBOTT QUICKSTART AMYLASE, #5AXX (K920583)Em Diagnostic Systems, Inc.1992-03-02
AMERLITE MAB FT4 ASSAY (K920247)Eastman Kodak Company1992-03-02
CONTINUOUS PASSIVE MOTION MODALITY ACCESSORY (K920270)Sports Medical Synergy1992-03-02
OPHTIMPLANT (K915630)Oculo Plastik, Inc.1992-03-02
VITAPAN ACRYLIC DENTURE TEETH (K914476)Vident1992-03-02
ACTH IRMA KIT II MITSUBISHI YUKA (K915727)Mitsubishi Yuka America, Inc.1992-03-02
MAGNI-CAM (K920069)Innoventions, Inc.1992-03-02
INTERLOCKING TIBIAL NAILING SYSTEM (K915435)Stryker Corp.1992-03-02
CEDIA DIGOXIN ASSAY (MODIFICATION) (K920214)Microgenics Corp.1992-03-02
MINI-MILL (K914035)Biomedical Composites, Ltd.1992-03-02
OPTICAL VALVULOTOME (K914385)Intramed Laboratories, Inc.1992-03-02
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Every clearance here is in the API, with alerts when new ones post.