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
171217–171240 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 03, 1978
REAGENT SET, U.V. ENZMATIC KINETIC, SGOT
K781725 · CIT
Medical Analysis Systems, Inc.
Chemistry · 23d
Cleared Nov 03, 1978
REAGENT SET, SGPT SERUM GLUTAMIC
K781726 · CKA
Medical Analysis Systems, Inc.
Chemistry · 23d
Cleared Nov 03, 1978
DISC, COLOPLAST PRE-OP STOMA
K781736 · EXA
C.R. Bard, Inc.
Gastroenterology & Urology · 22d
Cleared Nov 03, 1978
SCANNER, CT 0450
K781752 · JAK
Pfizer Medical Systems, Inc.
Radiology · 16d
Cleared Nov 03, 1978
TOMOGSCANNER 2
K781753 · KPS
Tomogscanner OK , Ltd.
Radiology · 17d
Cleared Nov 03, 1978
FRAME, UNIVERSAL DAY
K781793 · JEC
B.G. Orthopedic Corp.
Orthopedic · 9d
Cleared Nov 03, 1978
TINNITUS MASKER
K781798 · KLW
Starkey Laboratories, Inc.
Ear, Nose, Throat · 11d
Cleared Nov 03, 1978
MAXI-CHAIR
K781801 · HME
Surgical Mechanical Research, Inc.
Ophthalmic · 11d
Cleared Nov 03, 1978
RECORDER, HOLTER ELECTROCARDIOGRAM
K781843 · DSH
Hovik Corp.
Cardiovascular · 2d
Cleared Nov 03, 1978
LATEX, IN-HOUSE COMPOUNDED
K781847 · KGO
Arbrook Mfg. Corp.
General Hospital · 1d
Cleared Nov 01, 1978
LUBE-LOK
K781695 · CBH
Olympic Medical Corp.
Anesthesiology · 22d
Cleared Oct 31, 1978
PREGELLED DISPOSABLE E.K.G. ELECTRODE
K781430 · DRX
Vermont Medical, Inc.
Cardiovascular · 71d
Cleared Oct 31, 1978
EEG LEAD ASSEMBLY
K781494 · GXY
Graphic Controls Corp.
Neurology · 64d
Cleared Oct 31, 1978
MISTY-OX PREFILLED HUMIDIFIER, DISP.
K781600 · BTT
Davco
Anesthesiology · 43d
Cleared Oct 30, 1978
VARIABLE STIFFNESS WIRE GUIDE
K781393 · DQX
Cook, Inc.
Cardiovascular · 81d
Cleared Oct 27, 1978
STRAIN GAUGE PLETHYSMOGRAPH
K781352 · DSB
Medimatic
Cardiovascular · 81d
Cleared Oct 27, 1978
CASTLE MODEL 3146 GAS AERATOR
K781484 · FLI
Castle Co.
General Hospital · 60d
Cleared Oct 27, 1978
HEMO-W SYSTEM
K781628 · GKL
Coulter Electronics, Inc.
Hematology · 32d
Cleared Oct 27, 1978
SERI-SEP SERUM/PLASMA ISLOLATOR
K781629 · JKA
Wako Intl., Inc.
Chemistry · 32d
Cleared Oct 27, 1978
AUTODILUTER 2
K781645 · JQW
Dynatech Laboratories, Inc.
Chemistry · 32d
Cleared Oct 27, 1978
SRD-2
K781646 · JQW
Dynatech Laboratories, Inc.
Chemistry · 32d
Cleared Oct 27, 1978
RIA KIT, LH
K781685 · CEP
Amersham Corp.
Chemistry · 23d
Cleared Oct 27, 1978
L-CYSTEINE HYDROCHLORIDE
K781690 · JHS
Fisher Scientific Co., LLC
Chemistry · 23d
Cleared Oct 27, 1978
PRESSURE, LOW/HIGH MODEL C1070
K781697 · CAP
Timeter Instrument Corp.
Anesthesiology · 17d