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

Filters: Cleared only ×
176,076 results
170953–170976 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 1978
UREA NITROGEN TEST
K781899 · CDL
Wako Intl., Inc.
Chemistry · 37d
Cleared Dec 20, 1978
ANALYZER, AUTOMED CENTRIFUGAL
K781900 · JJG
Autogenic Systems
Chemistry · 37d
Cleared Dec 20, 1978
HUMAN II LENS
K781927 · HQG
Spectra-Shield, Inc.
Ophthalmic · 34d
Cleared Dec 20, 1978
NU-GLAZE
K781935 · ELL
Deringer-Ney, Inc.
Dental · 30d
Cleared Dec 20, 1978
COLUMN TEST, HEMOGLOBIN A
K781948 · LCP
Bio-Rad
Hematology · 29d
Cleared Dec 20, 1978
DIJI-DENT
K781962 · EFW
J&J Technologies, Inc.
Dental · 29d
Cleared Dec 20, 1978
APPLICATOR, LEE IMPRESSION
K781977 · EID
Lee Pharmaceuticals
Dental · 23d
Cleared Dec 20, 1978
SURGAIRTOME TWO
K781979 · HSZ
American Sterilizer Co.
Orthopedic · 23d
Cleared Dec 20, 1978
RADIATION ONCOLOGY SYSTEM
K782005 · KPQ
Adac Laboratories
Radiology · 16d
Cleared Dec 20, 1978
HYSTERECTOMY T DRAIN
K782027 · JOL
Davol, Inc.
General Hospital · 15d
Cleared Dec 20, 1978
ROUND SILICONE DRAIN
K782028 · GCY
Davol, Inc.
General & Plastic Surgery · 15d
Cleared Dec 20, 1978
PROCESSING SYSTEM, A2 IMAGE
K782047 · IYX
Medtronic Vascular
Radiology · 12d
Cleared Dec 20, 1978
MULTIFORMAT FILM CASSETTE TRANSPORT
K782060 · IYO
Mediscan, Inc.
Radiology · 12d
Cleared Dec 20, 1978
CATHETER, DIGITAL POSITRAL II
K782082 · DQO
C.R. Bard, Inc.
Cardiovascular · 6d
Cleared Dec 20, 1978
CLAMP, DISPOSABLE
K782090 · HXD
Concord Laboratories, Inc.
General & Plastic Surgery · 6d
Cleared Dec 19, 1978
ADAPTER KIT
K781864 · DTD
Daig Corp.
Cardiovascular · 43d
Cleared Dec 19, 1978
ELECTRODES, OFFSET AND DX
K781963 · DRX
Graphic Controls Corp.
Cardiovascular · 27d
Cleared Dec 18, 1978
ALARM UNIT, BATTERY OPERATED
K781158 · BZQ
Thompson Respiration Products, Inc.
Anesthesiology · 166d
Cleared Dec 15, 1978
SUPER-SORBER
K780938 · EYQ
Home Healthcare Products, Inc.
Gastroenterology & Urology · 190d
Cleared Dec 15, 1978
AQUA-GEL
K781032 · EXQ
Murray, Salk, Inc.
Gastroenterology & Urology · 179d
Cleared Dec 15, 1978
TUBE, LEATHERMAN/IMBRUCE
K781665 · GBA
National Catheter Co. Div. Mallinckrodt
General & Plastic Surgery · 78d
Cleared Dec 15, 1978
DIALYZER, PARALLEL FLOW DISPOSABLE
K781795 · FJG
Medical, Inc.
Gastroenterology & Urology · 51d
Cleared Dec 15, 1978
SPIROMETER, INCENTIVE CATALOG # 1750
K781831 · BWF
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 46d
Cleared Dec 15, 1978
UNDERPADS, HIGH ABSORBANT POLYMER
K781877 · KMF
Bridgewater Mfg. Corp.
General & Plastic Surgery · 39d