Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
151969–151992 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 21, 1984
WRINKLE CHAPEAU BLACKY
K842502 · HIS
Circle Rubber Corp.
Obstetrics & Gynecology · 87d
Cleared Sep 21, 1984
STANBIO QUICK-TELL MONOCLONAL INDIRECT
K842544 · JHJ
Stanbio Laboratory
Chemistry · 81d
Cleared Sep 21, 1984
ACE/FISHER EXTERNAL FIXATOR
K842768 · KTT
Buckman Co., Inc.
Orthopedic · 67d
Cleared Sep 21, 1984
DRABKIN REAGENT
K842931 · KAG
E K Ind., Inc.
Hematology · 58d
Cleared Sep 21, 1984
AXCAN UTERINE SUCCION INJECTOR
K842943 · HIG
Axcan Scientific Corp.
Obstetrics & Gynecology · 58d
Cleared Sep 21, 1984
ANGIO SYS STERILE FIELD COVER
K843257
Angiosystems, Inc.
General & Plastic Surgery · 32d
Cleared Sep 21, 1984
ANGIO SYS BRACHIAL ANGIO DRAPE
K843258
Angiosystems, Inc.
General & Plastic Surgery · 32d
Cleared Sep 21, 1984
ANGIO SYS FLUOROSCOPE DRAPE
K843259
Angiosystems, Inc.
General & Plastic Surgery · 32d
Cleared Sep 21, 1984
ANGIOSYS FEMORAL ANGIOGRAPHY DRAPE
K843260 · KKX
Angiosystems, Inc.
General Hospital · 32d
Cleared Sep 21, 1984
MINICAPS
K843361 · GIO
Medical Technomics, Ltd.
Hematology · 24d
Cleared Sep 21, 1984
RINGCAPS
K843362 · GIO
Medical Technomics, Ltd.
Hematology · 24d
Cleared Sep 21, 1984
PHARMA-PLAST PETRI DISH
K843483 · LIB
Zimmar Consulting , Ltd.
Microbiology · 15d
Cleared Sep 21, 1984
PRECISION DISPENSER
K843606 · JQW
Medical Technomics, Ltd.
Chemistry · 8d
Cleared Sep 21, 1984
LABOPETTOR
K843607 · JQW
Medical Technomics, Ltd.
Chemistry · 8d
Cleared Sep 20, 1984
SELF-ALIGNING ACETABULAR COMPONENT
K831792 · JDL
Endomedics, Inc.
Orthopedic · 475d
Cleared Sep 20, 1984
AUSTIN ENDOLYMPH DISPERSMENT SHUNT
K834094 · ESZ
Treace Medical, Inc.
Ear, Nose, Throat · 297d
Cleared Sep 20, 1984
SERVOMED MEDIVISION SCOPE SMV-235
K840209 · DXJ
Litton Medical Electronics
Cardiovascular · 245d
Cleared Sep 20, 1984
MEDILASER-S MEL-444-S
K840739 · GEX
Mochida Pharmaceutical Co., Ltd.
General & Plastic Surgery · 212d
Cleared Sep 20, 1984
SERVOMED OXCARDIORE SPIROGRAPH 324/111
K840832 · DRT
Litton Medical Electronics
Cardiovascular · 209d
Cleared Sep 20, 1984
FRONT RADIUS CUTTER
K841620 · HTX
Plastafil, Inc.
Orthopedic · 154d
Cleared Sep 20, 1984
BACK RADIUS CUTTER
K841621 · HTX
Plastafil, Inc.
Orthopedic · 154d
Cleared Sep 20, 1984
UNILET LANCET
K842517 · FML
Ulster Scientific, Inc.
General Hospital · 72d
Cleared Sep 20, 1984
AMIZYME-ANA TEST KIT
K842532 · LJM
Amico Lab, Inc.
Immunology · 84d
Cleared Sep 20, 1984
AMIZYME-ANDNA TEST KIT
K842533 · LJM
Amico Lab, Inc.
Immunology · 84d