Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: General Hospital ×
17,825 results
1369–1392 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 24, 2022
Sterile Syringe with Safety Needle for Single Use, Sterile Syringe with...
K212949 · MEG
Henan Nursecare Biotechnology Co., Ltd.
General Hospital · 161d
Cleared Feb 24, 2022
Bodygard SFS Surgical Gown Level 3
K202845 · FYA
Feliks Plastik Laminasyon VE Ambalaj...
General Hospital · 517d
Cleared Feb 22, 2022
Enbio S
K213991 · FLE
Enbio Group AG
General Hospital · 63d
Cleared Feb 21, 2022
Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use...
K213548 · LZA
Mercator Medical (Thailand), Ltd.
General Hospital · 105d
Cleared Feb 21, 2022
TMG Nitrile Powder Free Examination Glove
K213500 · LZA
Thai Medical Glove Co., Ltd.
General Hospital · 112d
Cleared Feb 21, 2022
EndoArmor™ + Surgical Gown
K203548 · FYA
Boston Scientific Corporation
General Hospital · 444d
Cleared Feb 20, 2022
Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange
K220232 · LZA
Megine Industries Sdn Bhd
General Hospital · 24d
Cleared Feb 20, 2022
Medical Surgical Mask
K213724 · FXX
Hunan Zhenheyikang Medical Instrument...
General Hospital · 86d
Cleared Feb 19, 2022
Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For...
K214110 · LZA
Mah Sing Healthcare Sdn. Bhd.
General Hospital · 52d
Cleared Feb 19, 2022
Disposable Medical Nitrile Examination Gloves
K213912 · LZA
Jiangsu Maolin Medical Technology...
General Hospital · 66d
Cleared Feb 19, 2022
Medical nitrile examination gloves (Model: SH001)
K213600 · LZA
Jiangxi Sanhao Medical Instruments...
General Hospital · 96d
Cleared Feb 19, 2022
EONS Nitrile Examination Gloves Powder Free
K213286 · LZA
Eons Gloves (Thailand) Co., Ltd.
General Hospital · 141d
Cleared Feb 19, 2022
Powder Free Nitrile Examination Gloves (White, Blue and Black)
K212998 · LZA
Alcatron Gloves Factory
General Hospital · 152d
Cleared Feb 19, 2022
Surgical Face Mask
K212863 · FXX
Taiwan Comfort Champ Manufacturing...
General Hospital · 164d
Cleared Feb 19, 2022
Heartland Health Surgical Mask
K212366 · FXX
Heartland Health Products
General Hospital · 204d
Cleared Feb 18, 2022
Nitrile Examination Gloves (Model: ZMG1351)
K213688 · LZA
Wuhan Zonsen Medical Products Co., Ltd.
General Hospital · 87d
Cleared Feb 18, 2022
Vinyl/Nitrile Blend Exam Glove
K213634 · LYZ
Dezhou Hengchang Medical Technology...
General Hospital · 93d
Cleared Feb 18, 2022
Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use...
K213440 · LZA
Luliang Hongruida Health Protection...
General Hospital · 116d
Cleared Feb 18, 2022
Powder Free Nitrile Examination Gloves, Blue,Test For Use With Chemotherapy...
K213306 · LZA
Zibo Sinocare Plastic Products Co., Ltd.
General Hospital · 137d
Cleared Feb 18, 2022
Ear Thermometer, Model ET001
K213079 · FLL
Guangzhou Berrcom Medical Device Co.,...
General Hospital · 148d
Cleared Feb 17, 2022
Vinyl Examination Gloves
K213625 · LYZ
Dezhou Hengchang Medical Technology...
General Hospital · 92d
Cleared Feb 17, 2022
Powder Free Blue Nitrile Examination Gloves
K213107 · LZA
Novid Ppe Sdn. Bhd.
General Hospital · 146d
Cleared Feb 17, 2022
Bluezone Model RX-450 Air Purifier
K212824 · FRA
Bluezone Products, Inc.
General Hospital · 167d
Cleared Feb 17, 2022
Amazing+
K212586 · LZA
Amazing Rubber Products Pvt, Ltd.
General Hospital · 185d