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
1345–1368 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Feb 17, 2022
Safety Pen Needle
K210864 · FMI
Sandstone Medical (Suzhou), Inc.
General Hospital · 331d
Cleared Feb 15, 2022
Sterile Auto-Disable Syringes with/without Needle for Single Use
K210229 · MEG
Zhejiang Kangkang Medical-Devices...
General Hospital · 383d
Cleared Feb 14, 2022
Vinyl Powder Free Examination Glove
K212011 · LYZ
Top Glove Vietnam Company Limited
General Hospital · 231d
Cleared Feb 11, 2022
B. Braun Introcan Safety 2 IV Catheter
K213664 · FOZ
B.Braun Medical, Inc.
General Hospital · 81d
Cleared Feb 11, 2022
Surgical Face Mask
K213617 · FXX
Megasoft (China) Co., Ltd.
General Hospital · 88d
Cleared Feb 10, 2022
Instylla Delivery Kit
K213632 · FMF
Instylla, Inc.
General Hospital · 85d
Cleared Feb 08, 2022
O'Star Nitrile Examination Gloves Powder Free
K213058 · LZA
Star Investment and Trade Joint Stock...
General Hospital · 139d
Cleared Feb 04, 2022
BD Vacutainer UltraTouch Push Button Blood Collection Set
K212724 · JKA
Becton, Dickinson and Company
General Hospital · 161d
Cleared Jan 28, 2022
Disposable Medical Nitrile Examination Gloves- Tested for Use With...
K213325 · LZC
Anhui Xinyisheng Medical Technology...
General Hospital · 115d
Cleared Jan 28, 2022
Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and...
K213142 · LZA
Shen Wei (Usa), Inc.
General Hospital · 123d