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
1009–1032 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 21, 2022
JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple)
K222349 · LZA
Jr Engineering & Medical Technologies...
General Hospital · 79d
Cleared Oct 21, 2022
Safety Blood Collection Needle (Without Needle Holder)
K222141 · JKA
Anhui Hongyu Wuzhou Medical...
General Hospital · 93d
Cleared Oct 21, 2022
CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU...
K210414 · FYC
Medtecs (Taiwan) Corp.
General Hospital · 617d
Cleared Oct 20, 2022
Disposable Surgical Gown (G4003)
K221977 · FYA
Xiantao Topmed Nonwoven Protective...
General Hospital · 107d
Cleared Oct 20, 2022
AccuSert Needle Inserter
K213429 · KZH
Emed Technologies Corporation
General Hospital · 364d
Cleared Oct 19, 2022
Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple
K220992 · LYZ
Ever Global (Vietnam) Enterprise...
General Hospital · 198d
Cleared Oct 18, 2022
Violet Nitrile Powder Free Patient Examination Glove, Non Sterile
K222721 · LZA
Safeskin Retailing (Hk) Limited
General Hospital · 40d
Cleared Oct 18, 2022
Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for...
K222298 · LZA
Onetexx Sdn Bhd
General Hospital · 78d
Cleared Oct 17, 2022
Powder Free Nitrile Examination Gloves (Blue, Black, White and/or Violet...
K222074 · LZA
Zibo Langu New Material Technology...
General Hospital · 95d
Cleared Oct 17, 2022
Disposable Syringe with permanently attached needle, Safety Syringe with...
K221308 · FMF
Jiangxi Maidikang Medical Devices...
General Hospital · 165d
Cleared Oct 16, 2022
SafeBreak Vascular
K222791 · QOI
Lineus Medical, LLC
General Hospital · 31d
Cleared Oct 14, 2022
Safety Insulin Pen Needles
K213183 · FMI
Zhejiang Kindly Medical Devices Co.,...
General Hospital · 380d
Cleared Oct 13, 2022
SCIg60 Infusion System
K222087 · PKP
Emed Technologies Corporation
General Hospital · 90d
Cleared Oct 12, 2022
MOST-T Autoclave
K220102 · FLE
Shinva Medical Instrument Co., Ltd.
General Hospital · 273d
Cleared Oct 11, 2022
Sol-M Luer Lock Syringe
K222744 · FMF
Sol-Millennium Medical, Inc.
General Hospital · 29d
Cleared Oct 11, 2022
Surgical Mask
K222335 · FXX
Luoyang Sunmed Devices Co., Ltd.
General Hospital · 69d
Cleared Oct 11, 2022
AAMI4 Isolation Gown
K214116 · FYC
Hubei Xinxin Non-Woven Co., Ltd.
General Hospital · 285d
Cleared Oct 08, 2022
Disposable Vinyl Examination Gloves
K223008 · LYZ
Jiangxi Handspro Products Solutions...
General Hospital · 9d
Cleared Oct 07, 2022
Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy...
K222714 · LZA
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 29d
Cleared Oct 07, 2022
SteriTite Container System with MediTray Parts
K221492 · KCT
Case Medical, Inc.
General Hospital · 137d
Cleared Oct 07, 2022
Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105,...
K221170 · FLL
Shenzhen AOJ Medical Technology Co.,...
General Hospital · 168d
Cleared Oct 07, 2022
AMSafe NeuFlo Needleless Connector
K220267 · FPA
Amsino International, Inc.
General Hospital · 249d
Cleared Oct 07, 2022
YADU Surgical Gowns
K220092 · FYA
Henan Yadu Industrial Co., Ltd.
General Hospital · 268d
Cleared Oct 07, 2022
Disposable Sterile Syringe with permanently attached needle
K220057 · MEG
Shinva Ande Healthcare Apparatus Co.,...
General Hospital · 274d