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
151081–151104 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 1984
GENERAL SURGICAL FILES
K844145 · GEO
Med-Tool, Inc.
General & Plastic Surgery · 28d
Cleared Nov 20, 1984
TOGGLE LOCKING PLIERS-STRAIGHT JAW, CURVED JAW
K844146 · HTC
Med-Tool, Inc.
General & Plastic Surgery · 28d
Cleared Nov 20, 1984
WIRE TWISTERS
K844147
Med-Tool, Inc.
General & Plastic Surgery · 28d
Cleared Nov 20, 1984
PIN CUTTER
K844148
Med-Tool, Inc.
General & Plastic Surgery · 28d
Cleared Nov 20, 1984
AMYLASE REAGENT CS-726
K844168 · CJA
Fisher Scientific Co., LLC
Chemistry · 26d
Cleared Nov 20, 1984
B-1000
K844226 · BZG
Biotrine Corp.
Anesthesiology · 19d
Cleared Nov 20, 1984
CHLORIDE STANDARD
K844235 · JIS
Shaban Mfg. Co.
Chemistry · 19d
Cleared Nov 20, 1984
ALKALINE PHOSPHATASE REAGENT SET
K844237 · CIO
Livonia Diagnostics, Inc.
Chemistry · 19d
Cleared Nov 20, 1984
SPIROMETRICS 2451 & SMI I
K844333 · BZG
Spirometrics, Inc.
Anesthesiology · 13d
Cleared Nov 19, 1984
MEDO MEDOMER MBF-100 II
K841235 · JOW
Medo U.S.A., Inc.
Cardiovascular · 242d
Cleared Nov 19, 1984
BAILEY LENS SHOOTER
K841730 · KYB
Intermedics Intraocular, Inc.
Ophthalmic · 208d
Cleared Nov 19, 1984
J4 MYO-MONITOR
K842223 · NUW
Myo-Tronics Research, Inc.
Dental · 167d
Cleared Nov 19, 1984
BNS 40
K842224 · NUW
Myo-Tronics Research, Inc.
Dental · 167d
Cleared Nov 19, 1984
UNILOC
K842465 · KWL
American Ortomed Corp.
Orthopedic · 147d
Cleared Nov 19, 1984
DOCUMENTOR
K842715 · DSI
Life Technology
Cardiovascular · 130d
Cleared Nov 19, 1984
FACTOR IX DEFICIENT PLASMA, B9D -
K843215 · GGP
Sigma Chemical Co.
Hematology · 96d
Cleared Nov 19, 1984
FACTOR X DEFICIENT PLASMA, BLOD HUMAN
K843310 · GGP
Sigma Chemical Co.
Hematology · 88d
Cleared Nov 19, 1984
LENSKEEPER LENS CARRYING CASE
K843342 · HPX
Allergan Pharmaceuticals, Inc.
Ophthalmic · 84d
Cleared Nov 19, 1984
EPISCLERAL VENOUS PRESSURE
K843354 · HKX
Eyetech, LLC
Ophthalmic · 84d
Cleared Nov 19, 1984
HEART-AID MODEL 80
K843358 · DRO
Cardiac Resucitator Corp.
Cardiovascular · 84d
Cleared Nov 19, 1984
FACTOR XI DEFICIENT PLASMA B11D
K843438 · GGP
Sigma Chemical Co.
Hematology · 76d
Cleared Nov 19, 1984
FACTOR XII DEFICIENT PLASMA B12D
K843451 · GGP
Sigma Chemical Co.
Hematology · 75d
Cleared Nov 19, 1984
PHARMA-PLAST OXYGEN CATHETER
K843466 · BZB
Zimmar Consulting , Ltd.
Anesthesiology · 74d
Cleared Nov 19, 1984
PHARMA-PLAST NASAL OXYGEN CANNULA
K843467 · CAT
Zimmar Consulting , Ltd.
Anesthesiology · 74d