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
1633–1656 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 20, 2021
Medline Digital Thermometer Non-Lubricated Probe Sheath
K211931 · FLL
Medline Industries, Inc.
General Hospital · 90d
Cleared Sep 20, 2021
Latex Examination Powder Free Gloves
K211477 · LYY
Aspen Glove Sdn. Bhd.
General Hospital · 131d
Cleared Sep 17, 2021
Vinyl Glove
K211904 · LYZ
Jiangsu Dihong Industry and Trade...
General Hospital · 88d
Cleared Sep 17, 2021
WELLTRUST WT-III Mask with Flat Earloop
K211751 · FXX
Lonestar Meadows, LLC
General Hospital · 102d
Cleared Sep 17, 2021
Unifine SafeControl
K210399 · FMI
Owen Mumford, Ltd.
General Hospital · 219d
Cleared Sep 17, 2021
Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))
K203418 · FXX
Ningbo Ouhan Medical Device Co., Ltd.
General Hospital · 302d
Cleared Sep 16, 2021
Blue Nitrile Examination Glove Powder Free
K211479 · LZA
Aspen Glove Sdn. Bhd.
General Hospital · 127d
Cleared Sep 16, 2021
Sterile Latex Surgical Gloves Powder Free
K211478 · KGO
Aspen Glove Sdn. Bhd.
General Hospital · 127d
Cleared Sep 16, 2021
Disposable Medical Mask
K203112 · FXX
Yangzhou Runyi Arts & Crafts Co., Ltd.
General Hospital · 336d
Cleared Sep 15, 2021
Disposable Nitrile Gloves
K212009 · LZA
Jiangsu Shenglijie Safety Products...
General Hospital · 79d
Cleared Sep 15, 2021
TrueCare Biomedix Tamper Evident Cap
K210818 · FMF
Us Infusion Inc. D/B/A Truecare...
General Hospital · 181d
Cleared Sep 15, 2021
INFRARED BODY THERMOMETER (Model: YK-001)
K210118 · FLL
Longnan Renzhong Medical Equipment...
General Hospital · 239d
Cleared Sep 15, 2021
Instrument tray, for semi-rigid ureteroscope
K203492 · KCT
Olympus Winter & Ibe GmbH
General Hospital · 300d
Cleared Sep 14, 2021
Nitta M&T Safety Box
K211464 · MMK
Nitta M&T (Thailand) Co., Ltd.
General Hospital · 126d
Cleared Sep 14, 2021
Wilson Tech Disposable Medical Face Mask
K210184 · FXX
Wilson Tech (International) Limited
General Hospital · 232d
Cleared Sep 13, 2021
Disposable Medical Mask
K203455 · FXX
Fujian Kang Chen Daily Necessities...
General Hospital · 294d
Cleared Sep 11, 2021
Surgical face mask
K211296 · FXX
Sunsmed Protective Products , Ltd.
General Hospital · 136d
Cleared Sep 10, 2021
Surgical Mask
K212451 · FXX
Remade USA, LLC
General Hospital · 36d
Cleared Sep 10, 2021
Sterile syringe for single use with/without needle
K210227 · FMF
Zhejiang Kangkang Medical-Devices...
General Hospital · 225d
Cleared Sep 09, 2021
Electronic Thermometer (XHF2001, XHF2002)
K211352 · FLL
Putian Hanjiang Huafeng Plastic Co.,...
General Hospital · 129d
Cleared Sep 09, 2021
Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes
K211242 · FMF
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 136d
Cleared Sep 08, 2021
Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask
K211832 · FXX
Zhejiang Lanhine Medical Products, Ltd.
General Hospital · 86d
Cleared Sep 08, 2021
Verifine Mechanical Safety Insulin Syringe
K210712 · FMF
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 182d
Cleared Sep 07, 2021
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid...
K211607 · MED
STERIS Corporation
General Hospital · 105d