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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
143569–143592 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 01, 1986
MP-070-M RADIOAEROSOL KIT
K862795 · IYT
Medipart Jerry Alexander
Radiology · 9d
Cleared Aug 01, 1986
MULTI-CHANNEL MICROPIPETTES
K862802 · JTC
Dynatech Laboratories, Inc.
Hematology · 10d
Cleared Aug 01, 1986
ITT INTERGRATED TABLE AND TUBESTAND
K862826 · IXQ
Garrels X-Ray Products, Inc.
Radiology · 7d
Cleared Aug 01, 1986
FCW TUBE STAND
K862827 · IYB
Garrels X-Ray Products, Inc.
Radiology · 7d
Cleared Aug 01, 1986
BSX BUCKY-STAND
K862828 · IXY
Garrels X-Ray Products, Inc.
Radiology · 7d
Cleared Jul 31, 1986
COMET COSMIC 203/218
K861527
Fuyo U.S.A. Co., Ltd.
General & Plastic Surgery · 98d
Cleared Jul 31, 1986
NIKKISO INFUSION PUMP MODEL PFA-02
K861539 · FRN
International Medical Products, Inc.
General Hospital · 98d
Cleared Jul 31, 1986
VAGINAL CHAMBER PELLETHANE-MEDICAL GRADE 2363
K861858 · HIR
Peritone Research, Ltd.
Gastroenterology & Urology · 78d
Cleared Jul 31, 1986
645OB SECTOR/LINEAR ULTRASOUND SCANNER
K861931 · HEM
Ge Medical Systems Information...
Obstetrics & Gynecology · 72d
Cleared Jul 31, 1986
BLOOD PLATELET ASSAY METHOD & APPARATUS
K862302 · JOZ
Bellhouse Medical, Inc.
Hematology · 44d
Cleared Jul 31, 1986
MILEX KEGEL PERINEAL EXERCISER
K862410 · HIR
Milex Products, Inc.
Gastroenterology & Urology · 36d
Cleared Jul 31, 1986
BT CATH (INTRAVASCULAR CATHETER)
K862480 · FOZ
Baron Technologies, Inc.
General Hospital · 31d
Cleared Jul 31, 1986
LUER LOCK ADAPTER/NUT
K862653 · FPA
Mallinckrodt Critical Care
General Hospital · 17d
Cleared Jul 31, 1986
PRISMA METAL OPAQUERS
K862660 · EBC
Dentsply Intl.
Dental · 17d
Cleared Jul 31, 1986
COBALT, 29.5% CHROMIUM ALLOY DENTAL BAKE-ON ALLOY
K862667 · EJH
Austenal Dental, Inc.
Dental · 17d
Cleared Jul 31, 1986
RIONET HEARING AID HB-35PT
K862670 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 17d
Cleared Jul 31, 1986
FLUOR-ETCH GEL ETCHANT
K862695 · EBC
Teledyne, Inc.
Dental · 16d
Cleared Jul 31, 1986
EUGENOL USP
K862745 · EMB
E&D Dental Manufacturing Co.
Dental · 10d
Cleared Jul 31, 1986
HEARING AID, UNITRON MODEL UF11
K862760 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 9d
Cleared Jul 30, 1986
SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE
K860689 · DSK
Spacelabs, Inc.
Cardiovascular · 155d
Cleared Jul 30, 1986
PS SYSTEM WITH SD-200 DOPPLER
K861358 · ITX
Johnson & Johnson Professionals, Inc.
Radiology · 111d
Cleared Jul 30, 1986
ACUSON L558 TRANSDUCER
K861579 · JOP
Acuson Computed Sonography
Cardiovascular · 93d
Cleared Jul 30, 1986
ACUSON S519 TRANSDUCER
K861596 · JOP
Acuson Computed Sonography
Cardiovascular · 92d
Cleared Jul 30, 1986
LAURIER SANTARY NAPKIN (MODIFICATION)
K862269 · HHD
Kao Corp.
Obstetrics & Gynecology · 47d