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

Filters: General Hospital ×
17,825 results
2065–2088 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jan 15, 2021
Non-contact Electronic Forehead Infrared Thermometer
K201582 · FLL
Zhongshan Jinli Electronic Weighing?...
General Hospital · 218d
Cleared Jan 15, 2021
Infrared Thermometer
K201579 · FLL
Shenzhen Xunwei Industrial Co., Ltd.
General Hospital · 218d
Cleared Jan 13, 2021
Procedure face mask (Model: KKF-2A)
K202314 · FXX
Han Zhaoqing Sporting Goods Company...
General Hospital · 149d
Cleared Jan 13, 2021
Polyisoprene Powder Free, Black Colour Surgical Gloves
K192933 · KGO
Emerson & Co. Srl
General Hospital · 454d
Cleared Jan 12, 2021
Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile)
K202843 · FXX
B.J.ZH.F.PANTHER MEDICAL EQUIPMENT...
General Hospital · 109d
Cleared Jan 12, 2021
Disposable Medical Surgical Mask
K201625 · FXX
Tianjin Saiyuan Technology Co., Ltd.
General Hospital · 211d
Cleared Jan 11, 2021
Medical Surgical Mask-Model MP002-5, MP002-6
K202577 · FXX
Jiangmen Sure&Me Medical Product Co.,...
General Hospital · 125d
Cleared Jan 08, 2021
Celerity 20 Steam Biological Indicator for IUSS
K202721 · FRC
STERIS Corporation
General Hospital · 113d
Cleared Jan 07, 2021
Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested...
K202622 · LZA
O&M Halyard, Inc.
General Hospital · 119d
Cleared Jan 07, 2021
Instylla Delivery Kit
K202544 · FMF
Instylla, Inc.
General Hospital · 127d
Cleared Jan 06, 2021
Medical Surgical Gowns
K202844 · FYA
Beijing Biosis Healing Biolog Ical...
General Hospital · 103d
Cleared Jan 06, 2021
Medical Surgical Masks-Non Sterile
K202594 · FXX
Shandong T&F Nonwoven Co., Ltd.
General Hospital · 120d
Cleared Jan 06, 2021
Disposable Surgical Face Mask
K202491 · FXX
Jiangsu Newvalue Medical Products...
General Hospital · 128d
Cleared Jan 05, 2021
iHealth Clinical Digital Thermometer
K202791 · FLL
Andon Health Co, Ltd.
General Hospital · 105d
Cleared Jan 05, 2021
NeutrArt
K201872 · FPA
Asset Medikal Tasarim As.
General Hospital · 182d
Cleared Jan 05, 2021
Non-contact Infrared Body Thermometer, model:HTD8823US
K200159 · FLL
Hetaida Technology Co., Ltd.
General Hospital · 349d
Cleared Jan 05, 2021
Insulin Syringe
K193273 · FMF
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 406d
Cleared Jan 04, 2021
Disposable Medical Face Masks
K202719 · FXX
Jiangxi Sanxin Medtec Co., Ltd.
General Hospital · 109d
Cleared Dec 31, 2020
Surgical Gown (Sterile), Surgical Gown (Non-sterile)
K202706 · FYA
B.J.ZH.F.PANTHER MEDICAL EQUIPMENT...
General Hospital · 106d
Cleared Dec 31, 2020
Promisemed Covered Safety Pen Needle
K202681 · FMI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 107d
Cleared Dec 31, 2020
Nordiwell Medical Face Mask
K202615 · FXX
Changzhou Combat Protective Equipment...
General Hospital · 113d
Cleared Dec 30, 2020
Remunity Pump for Remodulin (treprostinil) Injection
K202690 · QJY
Deka Research and Development
General Hospital · 106d
Cleared Dec 30, 2020
CrossRoads Tray System
K202268 · KCT
Crossroads Extremity Systems, LLC
General Hospital · 141d
Cleared Dec 30, 2020
JianYu Surgical Mask
K201754 · FXX
Jiangsu Jianyu Health Medical Co., Ltd.
General Hospital · 184d