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
163489–163512 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 20, 1981
EMIT-ST CANNABINOID CALIBRATOR
K812197 · DLJ
Syva Co.
Toxicology · 17d
Cleared Aug 20, 1981
CUDDLE CAP
K812216 · LDQ
Darcy, Inc.
General & Plastic Surgery · 15d
Cleared Aug 20, 1981
INTRAVENOUS ADMINISTRATION SET
K812231 · FPA
Cordis Corp.
General Hospital · 9d
Cleared Aug 20, 1981
COAT-A-COUNT T3 RIA KIT
K812246 · CDP
Diagnostic Products Corp.
Chemistry · 9d
Cleared Aug 20, 1981
CONDOM-52.XX
K812250 · KNX
Manfred Sauer Corp.
Gastroenterology & Urology · 9d
Cleared Aug 20, 1981
DISPOSABLE URINE GAB-70.XX
K812251 · KNX
Manfred Sauer Corp.
Gastroenterology & Urology · 9d
Cleared Aug 20, 1981
LATEX LEG BAG-57.XX
K812252 · KNX
Manfred Sauer Corp.
Gastroenterology & Urology · 9d
Cleared Aug 20, 1981
ETHICON LACRIMAL STENT
K812255 · HNL
Ethicon, Inc.
Ophthalmic · 8d
Cleared Aug 18, 1981
AFTERLOADING CATHETER SET
K811279
Mick Radio-Nuclear Instruments, Inc.
General & Plastic Surgery · 102d
Cleared Aug 18, 1981
ARTICULATED ARM B-SCANNER
K811426 · IYO
General Electric Co.
Radiology · 88d
Cleared Aug 18, 1981
HEMASPINNER
K811534 · GKJ
Geometric Data, Div. Smithkline Corp.
Hematology · 78d
Cleared Aug 18, 1981
NEEDLE GUIDE ATTACHMENT
K811931 · IYO
Technicare Corp.
Radiology · 43d
Cleared Aug 18, 1981
ATT-1 DENTAL COMPOSITE RESTORATIVE SYS
K811979 · EBF
American Midwest
Dental · 36d
Cleared Aug 18, 1981
SHARPS SAFE
K811997 · MMK
Instra-Metics, Inc.
General Hospital · 35d
Cleared Aug 18, 1981
MEVATRON 67E
K812032 · IYE
Siemens Medical Laboratories, Inc.
Radiology · 29d
Cleared Aug 18, 1981
IDS RAPIDS NH SYSTEMS
K812048 · JSX
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 29d
Cleared Aug 18, 1981
SILASTIC HEMI WRIST IMPLANT H.P. (RAD.)
K812053 · KXE
Dow Corning Corp. Healthcare...
Orthopedic · 28d
Cleared Aug 18, 1981
SR-1V DATA PRINTER
K812063 · HKO
American Optical Corp.
Ophthalmic · 28d
Cleared Aug 18, 1981
BORES* ADJUSTABLE BLADE HOLDER
K812070 · GDZ
Santa Barbara Medco, Inc.
General & Plastic Surgery · 28d
Cleared Aug 18, 1981
HELENA SICKLE-THAL QUIK COLUMN METHOD
K812077 · JPD
Helena Laboratories
Hematology · 27d
Cleared Aug 18, 1981
KOI LACREMAL HOOK & DILATOR
K812097 · HNW
Koi, Inc.
Ophthalmic · 25d
Cleared Aug 18, 1981
MINI NICHOLES
K812098 · CAH
Healthcare Ind.
General Hospital · 25d
Cleared Aug 18, 1981
BAK-ON SP PORCELAIN ALLOY
K812101 · EJS
Johnson & Johnson Professionals, Inc.
Dental · 25d
Cleared Aug 18, 1981
RECON 1
K812128 · CAX
Precision Metering, Inc.
Anesthesiology · 22d