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
193–216 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 14, 2025
Community Containers (Flap and Daisy)
K252637 · MMK
Keter Canada, Inc.
General Hospital · 55d
Cleared Oct 14, 2025
PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)
K251874 · MMK
Pureway Compliance, Inc.
General Hospital · 118d
Cleared Oct 14, 2025
FlowArt® Vial Access Device Vented
K251715 · LHI
Asset Medikal
General Hospital · 132d
Cleared Oct 10, 2025
SoClean 3+
K243815 · QXQ
Soclean, Inc.
General Hospital · 303d
Cleared Oct 08, 2025
BD Saf-T-Intima™ Subcutaneous Catheter System
K251422 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 154d
Cleared Sep 25, 2025
Steripath® Flow™ Blood Collection System
K251812 · JKA
Magnolia Medical Technologies
General Hospital · 105d
Cleared Sep 24, 2025
MEDRAD Centargo CT Injection System
K252689 · IZQ
Imaxeon Pty, Ltd.
General Hospital · 29d
Cleared Sep 24, 2025
Celerity™ 20 HP Biological Indicator
K252680 · FRC
STERIS Corporation
General Hospital · 30d
Cleared Sep 17, 2025
Vitaform Procedural Mask - Blue (Vitaform Blue)
K251902 · FXX
Vitacore Industries, Inc.
General Hospital · 89d
Cleared Sep 16, 2025
Medline Microtek C-Flo Bag Decanter, Sterile (2000S)
K251676 · LHI
Microtek Medical, LLC
General Hospital · 109d
Cleared Sep 15, 2025
Zener® (model ZEN-001-B1)
K252128 · FRA
Uvx, Inc.
General Hospital · 70d
Cleared Sep 12, 2025
BD PhaSeal™ Optima Connecting Set (C83-O)
K250059 · ONB
Becton, Dickinson and Company
General Hospital · 245d
Cleared Sep 05, 2025
Vaccess™ CT Low-Profile Power-Injectable Implantable Port
K252478 · LJT
Bard Access Systems, Inc.
General Hospital · 29d
Cleared Sep 05, 2025
High Pressure Tubing
K244038 · DXT
Shandong Int Medical Instruments Co.,...
General Hospital · 249d
Cleared Sep 04, 2025
Fluido® AirGuard System
K251733 · LGZ
The Surgical Company International BV...
General Hospital · 90d
Cleared Aug 29, 2025
EZ™ IV Administration Set
K251814 · FPA
Epic Medical Pte. , Ltd.
General Hospital · 77d
Cleared Aug 28, 2025
Powder-Free Vinyl Exam Gloves, clear
K252505 · LYZ
Basic Medical Technology, Inc.
General Hospital · 20d
Cleared Aug 28, 2025
SmartPilot YpsoMate NS-A2.25
K243901 · QOG
Ypsomed AG
General Hospital · 252d
Cleared Aug 27, 2025
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs,...
K251716 · LZA
Basic Medical Technology, Inc.
General Hospital · 84d
Cleared Aug 22, 2025
Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777)
K243660 · FMF
Cardinalhealth
General Hospital · 268d
Cleared Aug 21, 2025
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use...
K252244 · LZA
Ever Global (Vietnam) Enterprise...
General Hospital · 34d
Cleared Aug 19, 2025
Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested...
K250313 · KGO
Harps Europe Manufacturing GmbH
General Hospital · 197d
Cleared Aug 18, 2025
Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis...
K243604 · LZA
O&M Halyard, Inc.
General Hospital · 270d
Cleared Aug 14, 2025
Cassette Autoclave (ACA5)
K250164 · FLE
Guangzhou Ajax Medical Equipment Co.,...
General Hospital · 205d