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
1825–1848 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 07, 2021
Surgical Face Mask (Ear loops and Tie-on)
K210433 · FXX
Wuhan Dymex Healthcare Co., Ltd.
General Hospital · 115d
Cleared Jun 07, 2021
Disposable Surgical Mask
K210372 · FXX
Dongguan Shin YI Healthcare Products...
General Hospital · 119d
Cleared Jun 07, 2021
Disposable Surgical Mask
K202580 · FXX
Qingdao Likangyuan Medical Device...
General Hospital · 272d
Cleared Jun 04, 2021
Nitrile Patient Examination Gloves
K211028 · LZA
Huayuan Medical Technology(Shangqiu)...
General Hospital · 59d
Cleared Jun 04, 2021
Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)
K210014 · FLL
Guandong Genial Technology Co., Limited
General Hospital · 151d
Cleared Jun 04, 2021
Surgical face mask
K203704 · FXX
Juntech(Jiaxing)Healthcare Materials...
General Hospital · 168d
Cleared Jun 04, 2021
Disposable medical mask
K203388 · FXX
Everwin Toys (Dongguan)., Ltd.
General Hospital · 198d
Cleared Jun 03, 2021
Allmed Surgical Face Masks (Ear loops)
K202128 · FXX
Allmed Medical Products Co., Ltd.
General Hospital · 307d
Cleared Jun 02, 2021
ASM-301 Level 3 Surgical Mask
K211440 · FXX
American Surgical Mask Company, LLC
General Hospital · 23d
Cleared Jun 02, 2021
Disposable Surgical Face Mask
K210429 · FXX
Jiangxi Heying Pharmaceutical Co., Ltd.
General Hospital · 110d
Cleared Jun 02, 2021
Disposable Medical mask
K210150 · FXX
Hubei Wanli Protective Products Co.,...
General Hospital · 132d
Cleared Jun 02, 2021
Surgical Face Mask
K203190 · FXX
Rfx+Care Manufactoring Co., Ltd.
General Hospital · 218d
Cleared Jun 02, 2021
BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter...
K200891 · FOZ
Becton, Dickinson and Company
General Hospital · 425d
Cleared May 28, 2021
Infant Phototherapy Equipment
K210289 · LBI
Bistos Co., Ltd.
General Hospital · 115d
Cleared May 27, 2021
ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content...
K202765 · KGO
Careplus (M) Sdn Bhd
General Hospital · 248d
Not Cleared May 27, 2021
SafeBreak Vascular
DEN190043 · QOI
Site Saver, Inc. D/B/A Lineus Medical
General Hospital · 617d
Cleared May 26, 2021
Disposable Synthetic Examination Gloves
K210520 · LYZ
Shandong Shengshixincheng Medical...
General Hospital · 92d
Cleared May 25, 2021
AirMax Procedure Mask
K211275 · FXX
Premiumestore, LLC
General Hospital · 28d
Cleared May 20, 2021
YUWELL infrared ear thermometer: YHT101, YHT200
K203583 · FLL
Jiangsu Yuyue Medical Equipment&...
General Hospital · 163d
Cleared May 20, 2021
Surgical Isolation Gown
K203415 · FYC
Yanbian Pacific Textile Co., Ltd.
General Hospital · 182d
Cleared May 20, 2021
Procedure Mask, Surgical Mask
K202899 · FXX
Kenpax International Limited
General Hospital · 233d
Cleared May 19, 2021
Steam-Dot Process Indicator
K210553 · JOJ
Propper Manufacturing Co., Inc.
General Hospital · 83d
Cleared May 19, 2021
Turbett Instrument Pod
K202593 · FRG
Turbett Surgical, Inc.
General Hospital · 253d
Cleared May 19, 2021
Disposable Latex Powder Free Examination Gloves (Non-sterile)
K201576 · LYY
Pt. Universal Gloves
General Hospital · 342d