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
2305–2328 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 13, 2020
Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential...
K191869 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 245d
Cleared Mar 12, 2020
Health Line CT Midline Catheter
K200263 · FOZ
Health Line International Corporation
General Hospital · 38d
Cleared Mar 12, 2020
SpaceStation MRI
K191910 · MRZ
B. Braun Melsugen AG
General Hospital · 239d
Cleared Mar 10, 2020
JR.MEDIK Latex Surgeon’s Gloves Powder Free
K192328 · KGO
Jr Engineering & Medical Technologies...
General Hospital · 196d
Cleared Mar 06, 2020
SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove,...
K191915 · KGO
Medline Industries, Inc.
General Hospital · 233d
Cleared Mar 06, 2020
Avinent Surgical Tray
K191566 · KCT
Avinent Implant System S.L.U.
General Hospital · 267d
Cleared Mar 06, 2020
SwabTip Male Disinfectant Cap
K190918 · QBP
Icu Medical
General Hospital · 332d
Cleared Mar 05, 2020
Omnifix Low Dead Space Luer Lock Syringe
K193101 · FMF
B.Braun Medical, Inc.
General Hospital · 118d
Cleared Feb 28, 2020
SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use...
K192820 · KGO
Medline Industries, Inc.
General Hospital · 150d
Cleared Feb 28, 2020
Steripath Gen2 Blood Collection System
K192247 · JKA
Magnolia Medical Technologies, Inc.
General Hospital · 193d
Cleared Feb 21, 2020
Unity Subcutaneous Infusion System for Remodulin
K191313 · QJY
DEKA Research & Development
General Hospital · 282d
Cleared Feb 20, 2020
HydroPICC (PICC-142)
K193015 · LJS
Access Vascular, Inc.
General Hospital · 114d
Cleared Feb 20, 2020
Flowart
K190806 · FPA
Asset Medikal Tasarim As.
General Hospital · 328d
Cleared Feb 18, 2020
Safety Insulin Pen Needle
K192677 · FMI
Jiangsu Caina Medical Co.,Ltd
General Hospital · 145d
Cleared Feb 13, 2020
Praxiject 0.9% NaCl
K192414 · NGT
Medxl, Inc.
General Hospital · 162d
Cleared Feb 13, 2020
Microlife Non-Contact Infrared Forehead Thermometer
K191829 · FLL
Microlife Intellectual Property GmbH
General Hospital · 219d
Cleared Feb 13, 2020
EleGARD Patient Positioning System
K191689 · FOA
Minnesota Resuscitation Solutions,...
General Hospital · 233d
Cleared Feb 10, 2020
InPen System
K192841 · NDC
Companion Medical, Inc.
General Hospital · 130d
Cleared Feb 07, 2020
3M Attest Super Rapid 5 Steam-Plus Challenge Pack
K193154 · FRC
3M Company
General Hospital · 85d
Cleared Feb 04, 2020
Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button...
K191832 · JKA
Kurin, Inc.
General Hospital · 210d
Cleared Feb 03, 2020
Bella-mu
K190962 · FMI
U-Needle B.V.
General Hospital · 297d
Cleared Jan 31, 2020
Tamper Evident Cap
K193192 · FMF
International Medical Industries, Inc.
General Hospital · 73d
Cleared Jan 24, 2020
Gemini Titan Sterilization Wrap
K192641 · FRG
Medline Industries, Inc.
General Hospital · 122d
Cleared Jan 24, 2020
BD Cathena (TM) Safety IV Catheter
K192493 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 135d