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
1393–1416 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jan 18, 2022
Medical Face Mask
K210679 · FXX
Wuxi Yushou Medical Appliances Co., Ltd.
General Hospital · 316d
Cleared Jan 18, 2022
CHIRANA Insulin Syringes
K201044 · FMF
Chirana T. Injecta
General Hospital · 637d
Cleared Jan 17, 2022
Medical Face Mask
K212994 · FXX
Guangzhou Quantum Laser Intelligent...
General Hospital · 119d
Cleared Jan 16, 2022
Kangbeier Surgical Mask (Model: KBR-1001)
K213920 · FXX
Xinxiang Kangbeier Medical Technology...
General Hospital · 32d
Cleared Jan 16, 2022
Disposable Medical Face Mask
K211833 · FXX
Zhejiang the Purples Protective...
General Hospital · 216d
Cleared Jan 15, 2022
Disposable Nitrile Powder Free Examination Gloves (Non-sterile)
K211360 · LZA
Pt. Universal Gloves
General Hospital · 257d
Cleared Jan 14, 2022
SCOPE BUDDY PLUS Endoscope Flushing Aid
K213833 · FEB
Medivators, Inc.
General Hospital · 36d
Cleared Jan 14, 2022
Surgical Mask
K212997 · FXX
Guangdong Zhizhen Biological Medical...
General Hospital · 116d
Cleared Jan 14, 2022
Surgical Face Mask
K212913 · FXX
Jiangxi Ganlong Pharmaceutical Co., Ltd.
General Hospital · 123d
Cleared Jan 13, 2022
Stronghold Group Nitrile Examination Glove, Powder Free
K213859 · LZA
Stronghold Group, LLC
General Hospital · 34d
Cleared Jan 12, 2022
Surgical gowns
K212718 · FYA
Xiantao Dingcheng Non-Woven Product...
General Hospital · 138d
Cleared Jan 11, 2022
Medical Examination Gloves
K213168 · LZA
Shandong Huiwosheng Health Technology...
General Hospital · 105d
Cleared Jan 11, 2022
Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs)
K212735 · LZA
Xingyu Medical Tech Co., Ltd.
General Hospital · 134d
Cleared Jan 11, 2022
Disposable Surgical Gown
K212591 · FYA
Suzhou Janee Medical Technology Co.,...
General Hospital · 148d
Cleared Jan 10, 2022
Sheng Jing Tang Surgical Mask
K211260 · FXX
Liaoning Shengjingtang Biotechnology...
General Hospital · 259d
Cleared Jan 09, 2022
Powder free nitrile examination glove- black, non sterile
K212801 · LZA
Hong Seng Gloves Sdn Bhd
General Hospital · 129d
Cleared Jan 09, 2022
Powder Free Nitrile Examination Gloves, Blue Chemotest
K211666 · LZA
Careglove Global Sdn. Bhd.
General Hospital · 222d
Cleared Jan 07, 2022
CELERITY HP Chemical Indicator
K213262 · QKM
STERIS Corporation
General Hospital · 99d
Cleared Jan 07, 2022
DropSafe Safety Pen Needles
K211716 · FMI
Htl Strefa SA
General Hospital · 218d
Cleared Jan 07, 2022
Infrared Thermometer
K210564 · FLL
Alicn Medical (Shenzhen), Inc.
General Hospital · 316d
Cleared Jan 06, 2022
Penta Glove
K212847 · LZA
Pentavest Holdings Sdn Bhd
General Hospital · 121d
Cleared Jan 05, 2022
Vinyl Exam Gloves
K213019 · LYZ
Hebei Astro Medical Supply Co., Ltd.
General Hospital · 107d
Cleared Jan 04, 2022
T-Edge 10, T-Edge 11
K213080 · FLE
Tuttnauer , Ltd.
General Hospital · 103d
Cleared Jan 04, 2022
Disposable Medical Surgical Mask
K212375 · FXX
Jiangxi Bestgrand Health Technology...
General Hospital · 158d