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
156769–156792 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 1983
BAILEY ASPIRATOR/IRRIGATOR
K831584 · HQE
Medical Instrument Development...
Ophthalmic · 87d
Cleared Aug 12, 1983
MAXI SHIELDS
K831593 · HHD
Weyerhaeuser Co.
Obstetrics & Gynecology · 87d
Cleared Aug 12, 1983
INSPETOSCOPE
K831614 · ERA
Terayco Intl., Ltd.
Ear, Nose, Throat · 85d
Cleared Aug 12, 1983
GASTROSTOMY FEEDING SET
K831631 · KNT
Plasco, Inc.
Gastroenterology & Urology · 84d
Cleared Aug 12, 1983
FOGARTY-CHIN PERIPHERAL INTRAOPERATIVE
K831659 · LIT
American Edwards Laboratories
Cardiovascular · 81d
Cleared Aug 12, 1983
SUPRAMID EXTRA SURGICAL MESH
K831723 · FTM
S. Jackson, Inc.
General & Plastic Surgery · 73d
Cleared Aug 12, 1983
CHIN (MENTOPLASTY) IMPLANTS
K831724 · FWP
S. Jackson, Inc.
General & Plastic Surgery · 73d
Cleared Aug 12, 1983
QUARTER GLOBE CAPS
K831727 · FTM
S. Jackson, Inc.
General & Plastic Surgery · 73d
Cleared Aug 12, 1983
INTRACARDIA SUCKERS
K831759 · DWF
Research Industries Corp.
Cardiovascular · 72d
Cleared Aug 12, 1983
SIMPLICITY PLUS
K831761 · FRN
Critikon Company, LLC
General Hospital · 72d
Cleared Aug 12, 1983
VARIOUS CARDIOVASCULAR SURGICAL DEVICE
K831769 · DWF
Research Industries Corp.
Cardiovascular · 72d
Cleared Aug 12, 1983
AQUALIZER MOUTHPIECE
K831793 · KMY
Martin D. Lerman
Dental · 70d
Cleared Aug 12, 1983
AXIOM FEEDING GASTRO TUBE
K831823 · KNT
Axiom Medical, Inc.
Gastroenterology & Urology · 66d
Cleared Aug 12, 1983
FEEDING TUBE PLACEMENT STYLET
K831840 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 66d
Cleared Aug 12, 1983
PRESSURE MONITORING IV BOTTLE CAP
K831867 · DRS
Alto Development Corp.
Cardiovascular · 63d
Cleared Aug 12, 1983
ALLERGENETICS FLUORO-FAST READER
K831870 · JZT
Axonics, Inc.
Chemistry · 63d
Cleared Aug 12, 1983
BONE SCREW
K831873 · HWC
W.L. Gore & Associates, Inc.
Orthopedic · 60d
Cleared Aug 12, 1983
LIPASE REAGENT SET
K831874 · JGX
Sterling Biochemical, Inc.
Chemistry · 60d
Cleared Aug 12, 1983
HEARING AID UNITRON #UE8-D
K831883 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 60d
Cleared Aug 12, 1983
BETA I PROGRAMMABLE INFUSION PUMP
K831897 · FRN
Orange Medical Instruments, Inc.
General Hospital · 59d
Cleared Aug 12, 1983
ELECATH BALTHERM TLC THERMAL DILUTION
K831945 · DYG
Electro-Catheter Corp.
Cardiovascular · 57d
Cleared Aug 12, 1983
CRYOMEDICS NEUROSTAT
K831963 · GXH
Spembly Medical , Ltd.
Neurology · 56d
Cleared Aug 12, 1983
POWER OPTIC
K831976 · EAY
Ritter Co.
Dental · 53d
Cleared Aug 12, 1983
INFUTROL 7000 INFUSION PUMP
K832008 · FRN
Valleylab, Inc.
General Hospital · 50d