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
1633–1656 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 08, 2021
Medical Surgical Mask
K210813 · FXX
Sichuan Pharmaceutical., Inc.
General Hospital · 205d
Cleared Oct 08, 2021
Single-Use Medical Face Mask
K210622 · FXX
Jiangxi Hongda Medical Equipment...
General Hospital · 220d
Cleared Oct 08, 2021
Infrared Thermometer (Model K9)
K203497 · FLL
Kangzhan Communication Electronics...
General Hospital · 315d
Cleared Oct 07, 2021
Sterile syringes for single use with/without needle
K211211 · FMF
Azur Medical Company, Inc.
General Hospital · 167d
Cleared Oct 07, 2021
Surgical Gown
K211077 · FYA
Wujiang Tutaike Textiles & Finishing...
General Hospital · 178d
Cleared Oct 06, 2021
ZinRom Nitrile examination gloves
K211719 · LZA
Changzhou Xingrong Medical Technology...
General Hospital · 124d
Cleared Oct 06, 2021
Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)
K211621 · KGO
Careplus (M) Sdn Bhd
General Hospital · 133d
Cleared Oct 05, 2021
Nitrile Powder Free Examination Gloves,Tested For Use With Chemotherapy Drugs
K212036 · LZA
Jiangsu Yanfang Medical Technology...
General Hospital · 97d
Cleared Oct 05, 2021
Sterile hypodermic syringes for single use
K211728 · FMF
Jiangsu Kangyou Medical Instrument...
General Hospital · 123d
Cleared Oct 04, 2021
Surgical Face Mask
K211899 · FXX
Hubei Yi-Ya Protective Products Co.,...
General Hospital · 105d
Cleared Oct 04, 2021
Private Stock Labs Surgical Face Mask
K211425 · FXX
J.K. Private Stock, Inc.
General Hospital · 150d
Cleared Sep 30, 2021
SteriCap Mini Needle and Standard Needles
K212805 · FMI
Ocuject, LLC
General Hospital · 28d
Cleared Sep 30, 2021
Intravascular Administration Sets
K203609 · FPA
Baxter Healthcare Corporation
General Hospital · 294d
Cleared Sep 29, 2021
DR Safety Syringe, Sterile Hypodermic needle for Single use
K212226 · MEG
Zhuhai DR Medical Instruments Co., Ltd.
General Hospital · 75d
Cleared Sep 29, 2021
Disposable Nitrile Gloves
K211781 · LZA
Jiangsu Jinke Protective Equipment...
General Hospital · 112d
Cleared Sep 29, 2021
UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM...
K210513 · FXX
Universal Incorporation
General Hospital · 218d
Cleared Sep 28, 2021
Disposable surgical mask
K211794 · FXX
Shanghai No.9 Knitting Mill Co., Ltd.
General Hospital · 110d
Cleared Sep 28, 2021
Surgical Face Mask (Model: CM2006, CM2008, A88)
K210878 · FXX
Shenzhen Realtone Medical Appliance...
General Hospital · 188d
Cleared Sep 28, 2021
ThermArt (Model IR-EFT)
K202481 · FLL
Comper Chuangxiang (Beijing)...
General Hospital · 396d
Cleared Sep 27, 2021
Disposable Vinyl Examination Gloves
K211236 · LYZ
Tangshan Hongyun Healthcare Products...
General Hospital · 154d
Cleared Sep 27, 2021
B Dispensing Line
K203674 · LHI
Aea Srl
General Hospital · 285d
Cleared Sep 26, 2021
Surgical Mask
K210908 · FXX
Sichuan Prius Biotechnology Co., Ltd.
General Hospital · 181d
Cleared Sep 26, 2021
DT100 Digital Thermometer
K203731 · FLL
Smart Technology Co., Ltd.
General Hospital · 279d
Cleared Sep 26, 2021
Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter,...
K202459 · CAH
Pharma System AB
General Hospital · 395d