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
2017–2040 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 01, 2021
Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves
K203483 · KGO
Guilin Hbm Health Protections, Inc.
General Hospital · 66d
Cleared Jan 29, 2021
Protective Face Mask for Medical Use
K202358 · FXX
Hunan Heng Chang Pharmaceutical Co.,...
General Hospital · 163d
Cleared Jan 29, 2021
Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation...
K202310 · FYC
Wildcat Ppe, LLC
General Hospital · 168d
Cleared Jan 28, 2021
Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide
K203223 · NZA
Steris
General Hospital · 87d
Cleared Jan 28, 2021
Standard Sterilizable Tray
K202524 · KCT
Implant Direct Sybron Manufacturing, LLC
General Hospital · 149d
Cleared Jan 25, 2021
Non-Contact Forehead Thermometer (Models UT306H & UT308H)
K203747 · FLL
Uni-Trend Technology (China) Co., Ltd.
General Hospital · 34d
Cleared Jan 25, 2021
BD Hypodermic Syringe
K203453 · FMF
Becton, Dickinson and Company
General Hospital · 63d
Cleared Jan 22, 2021
Non-Contact Forehead Thermometer (UT30H)
K203656 · FLL
Uni-Trend Technology (China) Co., Ltd.
General Hospital · 38d
Cleared Jan 22, 2021
Surgical Mask
K202640 · FXX
Jiangsu Medpure Biological Technology...
General Hospital · 133d
Cleared Jan 21, 2021
AEROCURE-MD
K203189 · FRA
Aerobiotix, Inc.
General Hospital · 86d
Cleared Jan 21, 2021
Surgical Face Mask
K202904 · FXX
Jiangxi Feilikang Medical Technology...
General Hospital · 114d
Cleared Jan 21, 2021
Precision Delivery Infusion Set
K202672 · FPA
Quest Medical, Inc.
General Hospital · 128d
Cleared Jan 21, 2021
Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask
K202595 · FXX
Premier Guard USA, LLC
General Hospital · 135d
Cleared Jan 15, 2021
Medical Protective Mask
K202107 · FXX
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 170d
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