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
1969–1992 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 02, 2021
Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)
K202356 · LZA
Kanglongda Vietnam Protection...
General Hospital · 195d
Cleared Mar 02, 2021
IFM Surgical Mask Model SM3
K202214 · FXX
Fssc, LLC
General Hospital · 208d
Cleared Mar 02, 2021
Surgical Mask-Model Number: Ear Loop, Flat-Pleated
K201852 · FXX
Huizhou Foryou Medical Devices Co., Ltd.
General Hospital · 239d
Cleared Mar 02, 2021
Arisure Closed System Drug Transfer Device (CSTD)
K201422 · ONB
Yukon Medical, LLC
General Hospital · 277d
Cleared Mar 01, 2021
Nitrile Examination Gloves (Blue, Violet Blue, White)
K202402 · LZA
Jiangsu Tianshuo Medical Products...
General Hospital · 192d
Cleared Mar 01, 2021
Getinge GSS610N Series Steam Sterilizer
K201927 · FLE
Maquet GmbH
General Hospital · 234d
Cleared Mar 01, 2021
Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes
K201533 · KCT
Avinent Implant System S.L.U.
General Hospital · 266d
Cleared Feb 26, 2021
Disposable Vinyl Examination Gloves
K203439 · LYZ
Shandong Zhushi Pharmaceutical Group...
General Hospital · 95d
Cleared Feb 26, 2021
Medical infrared forehead thermometer
K202111 · FLL
Hunan Honggao Electronic Technolofy...
General Hospital · 211d
Cleared Feb 25, 2021
Surgical Masks
K203524 · FXX
Bain Medical Equipment (Guangzhou)...
General Hospital · 86d
Cleared Feb 25, 2021
Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C
K203332 · FLL
Hetaida Technology Co., Ltd.
General Hospital · 105d
Cleared Feb 25, 2021
Infrared Forehead Thermometer
K202420 · FLL
Conmo Electronic Company Limited
General Hospital · 185d
Cleared Feb 25, 2021
Disposable Surgical Mask/Fluid Resistant Procedure Mask
K202240 · FXX
Lhm Medical Technology (Hong Kong)...
General Hospital · 199d
Cleared Feb 25, 2021
KARL STORZ UDEL Sterilization Trays
K201945 · KCT
KARL STORZ Endoscopy-America, Inc.
General Hospital · 227d
Cleared Feb 25, 2021
TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE,...
K201142 · ONB
Simplivia Healthcare , Ltd.
General Hospital · 302d
Cleared Feb 24, 2021
Nitrile Powder Free Examination Glove, Blue Tested for Use with 32...
K202003 · LZA
Gmp Medicare Sdn. Bhd.
General Hospital · 219d
Cleared Feb 23, 2021
Molekule Air Mini, Molekule Air Mini +
K202339 · FRA
Molekule, Inc.
General Hospital · 190d
Cleared Feb 23, 2021
Velano ExT Extension Set
K200439 · FPA
Velano Vascular
General Hospital · 365d
Cleared Feb 22, 2021
Phyziofit Medical Surgical Mask
K201868 · FXX
Wellpower Sporting Goods Co., Ltd.
General Hospital · 230d
Cleared Feb 19, 2021
MiniLoad Syringe
K202432 · FMF
Ocuject, LLC
General Hospital · 178d
Cleared Feb 19, 2021
Safety Blood Collection Sets for Single Use
K202188 · JKA
Anhui Hongyu Wuzhou Medical...
General Hospital · 199d
Cleared Feb 19, 2021
iMask Disposable Surgical Face Mask
K201182 · FXX
Pac-Dent, Inc.
General Hospital · 294d
Cleared Feb 18, 2021
Surgical Face Mask (non-sterile)
K203426 · FXX
Nantong Taiweishi Medical Technology...
General Hospital · 90d
Cleared Feb 18, 2021
Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60
K202687 · FLL
Shenzhen Lepu Intelligent Medical...
General Hospital · 156d