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
2377–2400 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 05, 2019
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K191292 · LYZ
Anhui Powerguard Technology Co., Ltd.
General Hospital · 175d
Cleared Nov 05, 2019
MTS225 and MTS300 Multiple Tray Sterilization Systems
K190541 · KCT
Pmbs, LLC
General Hospital · 246d
Cleared Nov 04, 2019
WellDoc BlueStar
K190013 · MRZ
Welldoc, Inc.
General Hospital · 305d
Cleared Nov 01, 2019
BD Acute Central Line
K190855 · FOZ
Bard Access Systems, Inc. (Bard Has...
General Hospital · 213d
Cleared Nov 01, 2019
STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R)
K181993 · FLE
Sturdy Industrial Co., Ltd.
General Hospital · 463d
Cleared Oct 31, 2019
Belimed Steam Sterilizer MST-H TOP 5000
K191896 · FLE
Belimed AG
General Hospital · 108d
Cleared Oct 28, 2019
primeMidline Catheters
K192802 · PND
Pfm Medical, Inc.
General Hospital · 28d
Cleared Oct 28, 2019
3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228
K192673 · JOJ
3M Company
General Hospital · 32d
Cleared Oct 24, 2019
Latex Surgeon’s Gloves Powder Free with protein content labeling claim of...
K190632 · KGO
Lenora Glove Pvt , Ltd.
General Hospital · 226d
Cleared Oct 23, 2019
Intraosseous infusion device
K191258 · FMI
Einstein Works, LLC
General Hospital · 166d
Cleared Oct 23, 2019
Diana ChemoClave Transfer Set
K190157 · ONB
Icu Medical
General Hospital · 266d
Cleared Oct 23, 2019
Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black...
K183562 · LZC
Encompass Industries Sdn. Bhd.
General Hospital · 307d
Cleared Oct 22, 2019
Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle...
K192001 · FRC
Sterilucent, Inc.
General Hospital · 88d
Cleared Oct 22, 2019
TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile,...
K190539 · FMG
Monumedical, LLC
General Hospital · 232d
Cleared Oct 21, 2019
Omnipod Insulin Management System, Omnipod DASH Insulin Management System
K192659 · LZG
Insulet Corporation
General Hospital · 26d
Cleared Oct 21, 2019
Sterilucent VH2O2 Chemical Indicators
K191999 · JOJ
Sterilucent, Inc.
General Hospital · 87d
Cleared Oct 21, 2019
BD Insulin Syringe
K190054 · FMF
Becton, Dickinson and Company
General Hospital · 283d
Cleared Oct 21, 2019
Servo Guard
K182862 · CAH
Maquet Critical Care AB
General Hospital · 375d
Cleared Oct 18, 2019
Quantum Blood and Fluid Warming System
K192325 · LGZ
Life Warmer, Inc.
General Hospital · 52d
Cleared Oct 18, 2019
Infrared Forehead Thermometer (Model IR-FT)
K191668 · FLL
Comper Chuangxiang (Beijing)...
General Hospital · 119d
Cleared Oct 18, 2019
Infrared Thermometer, Breeze model
K191283 · FLL
Suzhou Melodicare Medical Technology...
General Hospital · 158d
Cleared Oct 17, 2019
DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System,...
K190102 · DXT
Osprey Medical, Inc.
General Hospital · 268d
Cleared Oct 15, 2019
TotalShield II Surgical Helmet System
K192194 · FYA
Zimmer Surgical, Inc.
General Hospital · 63d
Cleared Oct 15, 2019
Infared Thermometer
K191251 · FLL
Shenzhen Calibeur Industries Co., Ltd.
General Hospital · 159d