FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
13777–13800 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 21, 2022
EndoArmor™ + Surgical Gown
K203548 · FYA
Boston Scientific Corporation
General Hospital · 444d
Cleared Feb 21, 2022
TMG Nitrile Powder Free Examination Glove
K213500 · LZA
Thai Medical Glove Co., Ltd.
General Hospital · 112d
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 20, 2022
Medical Surgical Mask
K213724 · FXX
Hunan Zhenheyikang Medical Instrument...
General Hospital · 86d
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 19, 2022
Heartland Health Surgical Mask
K212366 · FXX
Heartland Health Products
General Hospital · 204d
Cleared Feb 19, 2022
Surgical Face Mask
K212863 · FXX
Taiwan Comfort Champ Manufacturing...
General Hospital · 164d
Cleared Feb 19, 2022
Air Pressure Foot Massager
K212935 · IRP
Xiamen Simo Electronic Co., Ltd.
Physical Medicine · 157d
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
Well-Life TENS/EMS/Heating Stimulator
K213091 · NUH
Well-Life Healthcare Limited
Neurology · 148d
Cleared Feb 19, 2022
EONS Nitrile Examination Gloves Powder Free
K213286 · LZA
Eons Gloves (Thailand) Co., Ltd.
General Hospital · 141d
Cleared Feb 19, 2022
Medical nitrile examination gloves (Model: SH001)
K213600 · LZA
Jiangxi Sanhao Medical Instruments...
General Hospital · 96d
Cleared Feb 19, 2022
Disposable Medical Nitrile Examination Gloves
K213912 · LZA
Jiangsu Maolin Medical Technology...
General Hospital · 66d
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 18, 2022
Traufix osteosynthesis, osteotomy, and arthrodesis devices
K201510 · HRS
Fixier S.A. DE C.V.
Orthopedic · 623d
Cleared Feb 18, 2022
Acetaminophen
K202644 · LDP
Sekisui Diagnostics P.E.I., Inc.
Toxicology · 525d
Cleared Feb 18, 2022
Pocket Ultrasound System
K211746 · IYN
Guangdong Youkey Medical Co., Ltd.
Radiology · 256d
Cleared Feb 18, 2022
Multitom Rax with True2scale Body Scan Option
K212212 · OWB
Siemens Medical Solutions
Radiology · 218d
Cleared Feb 18, 2022
SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test...
K212447 · LCX
Hangzhou Sejoy Electronics &...
Chemistry · 197d
Cleared Feb 18, 2022
True Tulip, True M.I.S.
K212627 · NKB
Innovative Surgical Designs, Inc.
Orthopedic · 183d
Cleared Feb 18, 2022
ExamVue Duo
K213057 · KPR
Jpi Healthcare Co, Ltd.
Radiology · 149d
Cleared Feb 18, 2022
Ear Thermometer, Model ET001
K213079 · FLL
Guangzhou Berrcom Medical Device Co.,...
General Hospital · 148d
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
Viz ANEURYSM, Viz ANX
K213319 · QFM
Viz. Ai, Inc.
Radiology · 137d