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
313–336 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 21, 2025
Arisure® Closed Male Luer with Spike Adapter (YM060)
K240761 · LHI
Yukon Medical, LLC
General Hospital · 366d
Cleared Mar 19, 2025
SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series...
K250502 · LZA
Safesource Direct, LLC
General Hospital · 27d
Not Cleared Mar 19, 2025
CORIS System
DEN240018 · SEW
Nanosonics Limited
General Hospital · 322d
Cleared Mar 18, 2025
Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile,...
K242533 · LZA
Better Care Plastic Technology Co., Ltd.
General Hospital · 204d
Cleared Mar 14, 2025
AION TempShield™
K250401 · FLL
Aion Biosystems, Inc.
General Hospital · 30d
Cleared Mar 14, 2025
Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)
K243599 · FOZ
Arrow International, LLC (A...
General Hospital · 113d
Cleared Mar 14, 2025
Solution Administration Sets
K243529 · FPA
Baxter Healthcare Corporation
General Hospital · 120d
Cleared Mar 14, 2025
Promisemed Safety Huber Needles
K243332 · PTI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 141d
Cleared Mar 11, 2025
RemunityPRO™ Pump for Remodulin® (treprostinil) Injection
K250357 · FRN
Deka Research & Development Corp.
General Hospital · 32d
Cleared Mar 07, 2025
FRONT-LINE Field Sterilizer (FL135)
K243801 · FLE
Fort Defiance Industries, LLC
General Hospital · 86d
Cleared Feb 28, 2025
Intravascular Extension Sets and Accessories
K242339 · FPA
Baxter Healthcare Corporation
General Hospital · 205d
Cleared Feb 27, 2025
PIVO™ Pro Needle-free Blood Collection Device
K241586 · JKA
Becton Dickinson Infusion Therapy...
General Hospital · 269d
Cleared Feb 26, 2025
Medline Level 4 Surgical Gown with Breathable Sleeves
K242844 · FYA
Medline Industries, LP
General Hospital · 159d
Cleared Feb 24, 2025
Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use...
K243959 · LZC
Lingshi Hongruida Health Protection...
General Hospital · 63d
Cleared Feb 24, 2025
Sterilization Package/Reel
K241565 · FRG
Anqing Clean Dental Instrument...
General Hospital · 269d
Cleared Feb 21, 2025
Medicom Sterilization Pouch and Reel
K243431 · FRG
Medicom Asia-Pacific Holdings Ltd....
General Hospital · 108d
Cleared Feb 21, 2025
Sterilization Pouches and Reels
K242898 · FRG
Shanghai Jianzhong Medical Packaging...
General Hospital · 151d
Cleared Feb 20, 2025
Green Card Bowie-Dick Test (BD115)
K250172 · JOJ
Steritec Products, Inc. (A Getinge...
General Hospital · 30d
Cleared Feb 19, 2025
Microdent Sterilization Cassette
K242023 · KCT
Implant Microdent System S.L.U.
General Hospital · 223d
Cleared Feb 18, 2025
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs,...
K243792 · LZA
Basic Medical Technology, Inc.
General Hospital · 70d
Cleared Feb 14, 2025
Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202,...
K243136 · FLL
Shenzhen Finicare Co., Ltd.
General Hospital · 137d
Cleared Feb 13, 2025
Body Temperature Software (BTS)
K243778 · QZA
Fitbit, LLC
General Hospital · 66d
Cleared Feb 11, 2025
NUVENTUS NV.C™ Surgical Cassette and Tray
K243317 · KCT
Infinitum Eta, Ltd.
General Hospital · 112d
Cleared Feb 06, 2025
Celerity Incubator
K250061 · FRC
STERIS Corporation
General Hospital · 27d