Find 510K Clearence requests from to with applicant of device name containing

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510(k) Number/Type
Applicant
Device
Advisory Committe
Date Received
Decision Date
More Info
K161689 OSSTEM IMPLANT Co., Ltd. OSSTEM Implant System - Abutment Dental 2016-06-20 2017-05-22
K161370 Medtronic Neurosurgery Durepair Dura Regeneration Matrix Neurology 2016-05-17 2016-11-02
K161327 SYNTEC SCIENTIFIC CORPORATION SYNTEC HUMERAL NAIL SYSTEM Orthopedic 2016-05-12 2017-06-08
K161277 BRIGHTWATER MEDICAL ConvertX Nephroureteral Stent System Gastroenterology, Urology 2016-05-06 2016-11-22
K161246 EWOO SOFT CO., LTD. Ez3D-i / E3 Radiology 2016-05-03 2016-05-31
K161216 IMMUNALYSIS CORPORATION Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators Clinical Toxicology 2016-04-29 2017-06-14
K161127 LIFE SPINE INC. The Small PLATEAU (PLATEAU-C) Spacer System Orthopedic 2016-04-21 2016-12-22
K160941 Brosmed Medical Co., Ltd. Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter Cardiovascular 2016-04-04 2016-12-13
K160847 ROCKWELL MEDICAL Rockwell Medical CitraPure Acid Concetrate Gastroenterology, Urology 2016-03-28 2016-10-20
K012291 THE BINDING SITE, LTD. HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA Immunology 2001-07-20 2001-08-20

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