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
1681–1704 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Sep 05, 2021
3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228
K212081 · JOJ
3M Company
General Hospital · 65d
Cleared Sep 03, 2021
Altor Safety 4-Ply Surgical Mask (Model:62232)
K211762 · FXX
Altor Safety, LLC
General Hospital · 87d
Cleared Sep 03, 2021
Infrared Thermometer, Model: HW-1
K211583 · FLL
Dongguan Simzo Electronic Technology...
General Hospital · 102d
Cleared Sep 02, 2021
Nitrile Examination Gloves, Green/ Blue/ Black Color
K211778 · LZA
Zhenjiang Suhui Latex Products Co., Ltd.
General Hospital · 85d
Cleared Sep 02, 2021
Nitrile Examination Gloves Powder Free (Blue)
K210868 · LZA
Great Eco Glove Sdn. Bhd.
General Hospital · 163d
Cleared Sep 01, 2021
Disposable Medical Nitrile Gloves
K211673 · LZA
Changzhou Yihua Sanitation Material...
General Hospital · 92d
Cleared Sep 01, 2021
Welspun Health Surgical Mask
K211536 · FXX
Welspun India Limited
General Hospital · 106d
Cleared Aug 31, 2021
PlusCare Temperature Probes, Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS,...
K203636 · FLL
Jkh USA, LLC
General Hospital · 260d
Cleared Aug 28, 2021
Nitrile Blue Powder-free Examination Glove
K211390 · LZA
Cardinal Health200, LLC
General Hospital · 115d
Cleared Aug 28, 2021
Surgical Mask
K211255 · FXX
Tianchang Kanghui Protective Products...
General Hospital · 124d
Cleared Aug 27, 2021
Stiletto Extended Dwell Catheter
K210047 · PND
Piper Access, LLC
General Hospital · 231d
Cleared Aug 27, 2021
Surgical mask
K202746 · FXX
Ningbo Jingeao Electronics, Inc.
General Hospital · 343d
Cleared Aug 26, 2021
Hypodermic Needle-Pro EDGE Safety Device
K211634 · FMI
Smiths Medical Asd, Inc.
General Hospital · 91d
Cleared Aug 26, 2021
Disposable Sterile Syringe, Disposable Sterile Syringe with Needle
K210991 · FMF
Guangdong Antmed Co., Ltd.
General Hospital · 146d