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
2113–2136 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 29, 2020
Curos Jet Disinfecting Cap
K200299 · QBP
3M Company
General Hospital · 266d
Cleared Oct 28, 2020
Sterile High-pressure Angiographic Syringes for single-use
K201395 · DXT
Youwo (Guangzhou) Medical Device Co.,...
General Hospital · 154d
Cleared Oct 26, 2020
Medline Glide-On 3G Vinyl Examination Gloves (Tested for use with...
K202179 · LYZ
Medline Industries, Inc.
General Hospital · 83d
Cleared Oct 26, 2020
Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use...
K200150 · LZA
Medline Industries, Inc.
General Hospital · 278d
Cleared Oct 23, 2020
Infrared ear and forehead thermometer, model YI-100
K201843 · FLL
Wenzhou Yosun Medical Technology Co.,Ltd
General Hospital · 109d
Cleared Oct 23, 2020
MaxZero Extension Sets with Needle-Free Connector(s)
K193088 · FPA
Carefusion, Inc.
General Hospital · 352d
Cleared Oct 21, 2020
S.I.N. Instrument Kits
K201688 · KCT
S.I.N. ? Sistema DE Implante Nacional...
General Hospital · 121d
Cleared Oct 21, 2020
Vial2Bag Advanced 20mm Admixture Device
K201415 · LHI
West Pharmaceutical Services Az, Inc.
General Hospital · 145d
Cleared Oct 16, 2020
Disposable Vinyl Glove
K202010 · LYZ
Better Health Medical Products Co., Ltd.
General Hospital · 87d
Cleared Oct 16, 2020
ARTHROTAP
K201816 · FMF
Accuro Technologies, Inc.
General Hospital · 107d
Cleared Oct 15, 2020
Droplet Pen Needle 30G & 33G
K202340 · FMI
Htl-Strefa S.A
General Hospital · 59d
Cleared Oct 11, 2020
Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free...
K200633 · LZC
0 & M Halyard, Inc.
General Hospital · 215d
Cleared Oct 08, 2020
Steripath Micro Blood Collection System
K200661 · FPA
Magnolia Medical Technologies, Inc.
General Hospital · 210d
Cleared Oct 07, 2020
Livocare Surgical Mask
K201380 · FXX
Andon Health Co, Ltd.
General Hospital · 134d
Cleared Oct 07, 2020
Infrared Thermometer
K200802 · FLL
Shenzhen Urion Technology Co., Ltd.
General Hospital · 194d
Cleared Oct 05, 2020
Neonatal Phototherapy System
K200031 · LBI
Avalon Biomedical (Shenzhen) Limited
General Hospital · 272d
Cleared Oct 02, 2020
Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram...
K201748 · KGO
Hartalega Sdn Bhd
General Hospital · 98d
Cleared Oct 02, 2020
Infrared Thermometer Model E127
K201161 · FLL
Bioland Technology, Ltd.
General Hospital · 155d
Cleared Oct 01, 2020
Infrared PT2L Digital No-Touch Thermometer
K200710 · FLL
Andon Health Co, Ltd.
General Hospital · 197d
Cleared Sep 25, 2020
Surgical Face Mask
K202277 · FXX
Jiangxi 3l Medical Products Group...
General Hospital · 45d
Cleared Sep 25, 2020
PUGGLE Enteral Feeding Pump and Feeding Set
K200051 · LZH
Amsino International, Inc.
General Hospital · 259d
Cleared Sep 22, 2020
BD Cathena Safety IV Catheter
K201717 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 91d
Cleared Sep 22, 2020
Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with...
K200843 · LZA
O&M Halyard, Inc.
General Hospital · 175d
Cleared Sep 18, 2020
Disposable Surgical Mask
K202463 · FXX
Unisources Group, LLC
General Hospital · 22d