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
157081–157104 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 18, 1983
EXTERNAL INCONTINENCE CATHETER TAKE-HOME
K832109 · KNX
Plasco, Inc.
Gastroenterology & Urology · 19d
Cleared Jul 18, 1983
DACOMED SNAP-GAUGE
K832121 · LIL
Dacomed Corp.
Gastroenterology & Urology · 18d
Cleared Jul 14, 1983
GENERAL SURGICAL INSTRUMENTS
K831805 · GEN
Aim Corp.
General & Plastic Surgery · 38d
Cleared Jul 12, 1983
SYSTEM 80 FACEPLATE-IN-THE-EAR #F1
K822411 · EIB
Western Advanced Technology, Inc.
Dental · 336d
Cleared Jul 12, 1983
MICROVEL DOUBLE VELOUR SUPPORTED 100
K822633 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 315d
Cleared Jul 12, 1983
PORTABLE MONITORING & SCREENING SPIROM.
K822689 · BZK
Boehringer Laboratories
Anesthesiology · 312d
Cleared Jul 12, 1983
BROOKS SCLEROTHERAPY CUFF
K823475 · KNT
Inmed Corp.
Gastroenterology & Urology · 232d
Cleared Jul 12, 1983
NICOLET EMG SATELLITE
K830702 · IKN
Nicolet Biomedical Instruments
Neurology · 127d
Cleared Jul 12, 1983
PERSONAL AMPLIFIER MODULE
K830790 · ESD
Electone, Inc.
Ear, Nose, Throat · 120d
Cleared Jul 12, 1983
WEBER/STIIHMER FEMORAL HEAD PROSTHESIS
K830948 · JDI
Allo Pro Corp.
Orthopedic · 110d
Cleared Jul 12, 1983
DAP II BIOPSY GUIDE
K830999 · HAW
Rapid Machine & Tool Corp.
Neurology · 105d
Cleared Jul 12, 1983
LAMOREUX-OSI ELECTROGONIOMETER
K831040 · KQX
Orthopedic Systems, Inc.
Neurology · 103d
Cleared Jul 12, 1983
BARD INTRAMEDULLARY PLUG
K831128 · JDK
C.R. Bard, Inc.
Orthopedic · 97d
Cleared Jul 12, 1983
COMMAND ULTRA II
K831216 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 89d
Cleared Jul 12, 1983
INTERFERENCE MEDULLARY FIT -IMF-HIP
K831314 · JDI
Depuy, Inc.
Orthopedic · 81d
Cleared Jul 12, 1983
TRU-CUT BIOPSY/ASPIRA-NEEDLE 2N2709
K831392 · GAA
Travenol Laboratories, S.A.
General & Plastic Surgery · 74d
Cleared Jul 12, 1983
AS 30/TCP MODULE
K831460 · KLK
Narco Scientific
Anesthesiology · 67d
Cleared Jul 12, 1983
THORACIC GAUGE #TG-60 -VACUUM REGULATOR
K831505 · KDP
Sorensen Research
General Hospital · 62d
Cleared Jul 12, 1983
OCULAR IRRIGATING CANNULA
K831532 · HMX
Dey Laboratories, Inc.
Ophthalmic · 60d
Cleared Jul 12, 1983
ORTHOPEDIC SURGICAL GLOVE
K831564 · FMC
Ansell, Inc.
General Hospital · 57d
Cleared Jul 12, 1983
DROP RATE COUNTER #340
K831596 · FLN
Imed Corp.
General Hospital · 56d
Cleared Jul 12, 1983
INTRADISCAL THERAPY NEEDLE
K831610 · FMI
Bd Becton Dickinson Vacutainer...
General Hospital · 54d
Cleared Jul 12, 1983
SONIC MIST ULTRASONIC HUMIDIFIER
K831646 · KFZ
Douglas Products
Anesthesiology · 54d
Cleared Jul 12, 1983
SIALOGRAPHY NEEDLE
K831666
Vertex Medical Corp.
General & Plastic Surgery · 50d