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
164617–164640 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 21, 1981
SECURE
K810959 · DYH
Sci-Pharm, Inc.
Dental · 13d
Cleared Apr 21, 1981
DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT
K810966 · DNL
E. R. Squibb & Sons, Inc.
Toxicology · 13d
Cleared Apr 17, 1981
GOT ISOENZYME ASSAY EIKEN KIT
K802447 · CIT
Syn-Kit, Inc.
Chemistry · 191d
Cleared Apr 17, 1981
PULLEN POCKET SCOPE
K802818 · IBJ
P.A. Research Corp.
Microbiology · 161d
Cleared Apr 17, 1981
DIGITAL DIAGNOSTIC ULTRASOUND DEVICE
K810038 · IYO
Rohe Scientific Corp.
Radiology · 98d
Cleared Apr 17, 1981
DAC-CEL HCG
K810215 · JHI
Burroughs Wellcome Co.
Chemistry · 80d
Cleared Apr 17, 1981
BARNES-HIND ROSE BENGAL OPHTHALMIC STR.
K810285 · KYC
Barnes-Hind, Inc.
Ophthalmic · 74d
Cleared Apr 17, 1981
STERI-VERS
K810311 · LDS
The Hilrad Co.
General Hospital · 71d
Cleared Apr 17, 1981
SHILEY S-100A (ADULT) BLOOD OXYGENATOR
K810470 · DTZ
Shiley, Inc.
Cardiovascular · 53d
Cleared Apr 17, 1981
SONTEK ANGIOGRAPHIC CATHETER
K810508 · DQO
Sontek Corp.
Cardiovascular · 52d
Cleared Apr 17, 1981
DISPOSABLE 22MM. FLEXIBLE ADAPTOR
K810621 · BZA
Intec Medical, Inc.
Anesthesiology · 39d
Cleared Apr 17, 1981
POLARISED LIGHT GRONIOMETER
K810640 · KQX
Cairco , Ltd.
Neurology · 38d
Cleared Apr 17, 1981
GILUCOCHEK REFLECTANCE METER
K810665 · JJQ
Lifescan, Inc.
Chemistry · 37d
Cleared Apr 17, 1981
MS-303-OXYGEN REGULATOR SHIELD
K810679 · CAN
Instrumentation Industries, Inc.
Anesthesiology · 35d
Cleared Apr 17, 1981
ENDOTRACHEAL TUBE HOLDER
K810737 · CBH
Aircare Systems
Anesthesiology · 30d
Cleared Apr 17, 1981
5 MHZ TRANSDUCER
K810749 · ITX
General Electric Co.
Radiology · 28d
Cleared Apr 17, 1981
SURGICAL TUBE HOLDER
K810788 · FZX
The Urology Group
General & Plastic Surgery · 25d
Cleared Apr 17, 1981
AMICON ULTRAFILTRATION MEMBRANES CMII
K810810 · DHX
Amicon, Inc.
Chemistry · 24d
Cleared Apr 17, 1981
DRAINING-WOUND MGMT. SYSTEM
K810812 · EXB
Johnson & Johnson Professionals, Inc.
Chemistry · 24d
Cleared Apr 17, 1981
ERIKA EXTENSION SETS
K810823 · FJK
Erika, Inc.
Gastroenterology & Urology · 24d
Cleared Apr 17, 1981
ERIKA HEPARIN INFUSION ADAPTOR
K810824 · FJK
Erika, Inc.
Gastroenterology & Urology · 24d
Cleared Apr 17, 1981
SWEEN UNIVERSAL BED RAIL PADS
K810846 · FNJ
Sween Corp.
General Hospital · 21d
Cleared Apr 17, 1981
CORDIS BIOPSY FORCEPS
K810849 · DWZ
Cordis Corp.
Cardiovascular · 18d
Cleared Apr 17, 1981
KANGAROO NASOGASTRIC FEEDING TUBE
K810854 · KNT
Chesebrough-Pond'S U.S.A. Co.
Gastroenterology & Urology · 18d