FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,791 results
1945–1968 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Mar 07, 2021
Single-use medical face mask
K201974 · FXX
Guangdong Horigen Mother & Baby...
General Hospital · 235d
Cleared Mar 05, 2021
Surgical Mask
K203425 · FXX
Bdc Dental Corporation , Ltd.
General Hospital · 105d
Cleared Mar 05, 2021
Biodegradable Thermoplastic Elastomer Examination (TPE) Glove
K202078 · LZA
Shen Wei (Usa), Inc.
General Hospital · 221d
Cleared Mar 05, 2021
Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and...
K202076 · LZA
Shen Wei (Usa), Inc.
General Hospital · 221d
Cleared Mar 04, 2021
Surgical Face Mask
K210225 · FXX
Feng Chun Yuan Medical Equipment...
General Hospital · 35d
Cleared Mar 04, 2021
BD Intraosseous Infusion System
K203193 · MHC
Bard Access Systems,...
General Hospital · 127d
Cleared Mar 04, 2021
Disposable medical mask
K202137 · FXX
U-Play Products Corporation
General Hospital · 216d
Cleared Mar 03, 2021
3M Attest Rapid Readout Biological Indicator, 1295
K210277 · FRC
3M Company
General Hospital · 30d
Cleared Mar 03, 2021
EOGas 4 Endo-SteriTest RRBI
K202879 · FRC
Andersen Sterilizers, Inc.
General Hospital · 156d
Cleared Mar 03, 2021
Medical mask (Model: KKF-1A)
K202316 · FXX
Han Zhaoqing Sporting Goods Company...
General Hospital · 198d