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
32545–32568 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared CT Mar 18, 2016
CorPath 200 System
K152999 · DXX
Corindus, Inc.
Cardiovascular · 157d
Cleared Mar 18, 2016
SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine...
K153646 · DIO
Safecare Biotech (Hangzhou) Co., Ltd.
Toxicology · 88d
Cleared Mar 18, 2016
Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug...
K153693 · LAF
Immunalysis Corporation
Toxicology · 86d
Cleared Mar 18, 2016
Tuxedo Digital Dental Sensor
K153710 · MQB
Led Dental, Inc.
Radiology · 85d
Cleared Mar 18, 2016
CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test
K153741 · LDJ
Hangzhou Clongene Biotech Co., Ltd.
Toxicology · 81d
Cleared Mar 18, 2016
NILE Alternative Fixation Spinal System
K160208 · OWI
K2m, Inc.
Orthopedic · 50d
Cleared Mar 18, 2016
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip
K160454 · FZP
AtriCure, Inc.
General & Plastic Surgery · 29d
Cleared Mar 18, 2016
Optetrak Advanced Patella
K160484 · JWH
Exactech, Inc.
Orthopedic · 25d
Cleared Mar 18, 2016
Quanta System Surgical Laser fibers
K160513 · GEX
Quanta System Spa
General & Plastic Surgery · 23d
Cleared Mar 18, 2016
FibroScan 530 Compact
K160524 · IYO
Echosens
Radiology · 22d
Cleared Mar 17, 2016
MetaNeb 4 System
K151689 · NHJ
Hill-Rom Services Pte, Ltd.
Anesthesiology · 268d
Cleared CT Mar 17, 2016
Specular Microscope CEM- 530
K151706 · NQE
Nidek Co., Ltd.
Ophthalmic · 267d
Cleared Mar 17, 2016
Sungshim Insulin Pen Needle
K152334 · FMI
Sung Shim Medicare Co., Ltd.
General Hospital · 211d
Cleared Mar 17, 2016
Endo Keeper
K152598 · OTJ
Nelis
General & Plastic Surgery · 188d
Cleared Mar 17, 2016
CONQUEST FN
K152686 · JDO
Smith & Nephew
Orthopedic · 181d
Cleared Mar 17, 2016
Apollo System
K152699 · GWG
Penumbra, Inc.
Neurology · 178d
Cleared Mar 17, 2016
Jiayuan Nitrile Powder Free Patient Examination Gloves, Blue Color
K152705 · LZA
Jiayuan Medical Products Co., Ltd.
General Hospital · 178d
Cleared Mar 17, 2016
Minghao Nitrile Powder Free Patient Examination Gloves, Blue Color
K152707 · LZA
Minghao Medical Products Co., Ltd.
General Hospital · 178d
Cleared Mar 17, 2016
Giraffe OmniBed Carestation CS1
K152814 · FMZ
Ohmeda Medical, A Division of...
General Hospital · 171d
Cleared Mar 17, 2016
LiDCOunity Monitor
K152935 · DXG
Lidco, Ltd.
Cardiovascular · 164d
Cleared Mar 17, 2016
Axeo 3 Patient Monitor
K153079 · MWI
Axeo Medical Technologies, LLC
Cardiovascular · 146d
Cleared Mar 17, 2016
NuVasive® TLX Interbody System
K153627 · MAX
Nu Vasive, Incorporated
Orthopedic · 90d
Cleared Mar 17, 2016
OVENT
K160234 · LRK
Oventus Manufacturing Pty, Ltd.
Dental · 45d
Cleared Mar 17, 2016
Rezum System
K160417 · KNS
Nxthera, Inc.
Gastroenterology & Urology · 30d