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
1969–1992 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 19, 2021
Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis...
K202081 · LZA
Shen Wei (Usa), Inc.
General Hospital · 235d
Cleared Mar 19, 2021
Sovereign America Surgical Face Mask
K201095 · FXX
Homtex, Inc.
General Hospital · 329d
Cleared Mar 18, 2021
Spin Care Disposable Protective Mask
K201624 · FXX
Spintech, LLC
General Hospital · 276d
Cleared Mar 17, 2021
Biodegradable Powder Free Nitrile Examination Glove, Green-White and...
K202082 · LZA
Shen Wei (Usa), Inc.
General Hospital · 233d
Cleared Mar 16, 2021
MIPLNI YK-244 Disposable Surgical Mask
K210487 · FXX
Hunan Yuankang Biological Technology...
General Hospital · 25d
Cleared Mar 16, 2021
Biodegradable Powder Free Nitrile Examination Glove, Low Dermatitis,Potential...
K202086 · LZA
Shen Wei (Usa), Inc.
General Hospital · 232d
Cleared Mar 15, 2021
Single-Use Surgical Mask
K201924 · FXX
Qiqihar Hengxin Medical Supplies, Ltd.
General Hospital · 248d
Cleared Mar 15, 2021
Medical Surgical Mask
K201698 · FXX
Hangzhou Mycode Bio-Medicine Co., Ltd.
General Hospital · 266d
Cleared Mar 12, 2021
AIC disposable medical mask
K203775 · FXX
The Aleen International Corporation
General Hospital · 74d
Cleared Mar 12, 2021
Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603
K203707 · FLL
Shenzhen Zhengkang Technology Co., Ltd.
General Hospital · 84d
Cleared Mar 12, 2021
Vinyl Examination Gloves(Yellow)
K203666 · LYZ
Lutai Medical Technology Co., Ltd.
General Hospital · 86d
Cleared Mar 12, 2021
Groshong NXT PICC Catheter
K201452 · LJS
C.R. Bard, Inc.
General Hospital · 284d
Cleared Mar 10, 2021
Surgical Face Mask
K202548 · FXX
Wanxinda (Guangzhou) Technology...
General Hospital · 189d
Cleared Mar 10, 2021
Surgical Mask
K202411 · FXX
Allmed Medical Products Co., Ltd.
General Hospital · 201d
Cleared Mar 10, 2021
Surgical Face Mask
K202161 · FXX
Hunan Eexi Technology & Service Co.,...
General Hospital · 219d
Cleared Mar 09, 2021
Nordiwell Surgical Face Mask
K210181 · FXX
Changzhou Combat Protective Equipment...
General Hospital · 46d
Cleared Mar 09, 2021
Neodent EasyGuide Kit Cases
K203618 · KCT
Jjgc Industria E Comercio DE...
General Hospital · 88d
Cleared Mar 09, 2021
Disposable Medical Face Mask
K202710 · FXX
Wanxinda (Guangzhou) Technology...
General Hospital · 174d
Cleared Mar 09, 2021
Body Infrared Thermometer HT-820D
K202591 · FLL
Dongguan Xintai Instrument Co., Ltd.
General Hospital · 182d
Cleared Mar 09, 2021
Surgical Mask
K202409 · FXX
Allmed Medical Products Co., Ltd.
General Hospital · 200d
Cleared Mar 09, 2021
Surgical Face Mask
K202205 · FXX
Jiangsu Micsafe Medical Technology...
General Hospital · 216d
Cleared Mar 09, 2021
Infrared Thermometer
K201508 · FLL
Dongguan Prestige Sporting Goods Co.,...
General Hospital · 277d
Cleared Mar 08, 2021
iHealth Wireless No-Touch Forehead Thermometer
K202753 · FLL
Andon Health Co, Ltd.
General Hospital · 168d
Cleared Mar 08, 2021
Disposable Medical Face Mask
K202439 · FXX
Hunan Eexi Technology & Service Co.,...
General Hospital · 195d