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
1–24 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 30, 2026
Foster Plus-22L (SNK/CE-F22)
K260354 · FLE
Zhejiang Fomos Medical Technology...
General Hospital · 269d
Cleared Oct 29, 2026
V-Pro maX 2 Low Temperature Sterilization System
K263530 · MLR
Steris
General Hospital · 30d
Cleared Oct 29, 2026
Lumicare (ONE)
K260427 · SCS
Lumicare Medtech Co., Ltd.
General Hospital · 261d
Cleared Oct 29, 2026
Powder Free Nitrite Examination Glove, Cobalt Blue. Violet Blue and White....
K253508 · LZA
Vietglove Corporation
General Hospital · 360d
Cleared Oct 28, 2026
Profoject™ Safe Push Button Blood Collection Sets
K262242 · JKA
CMT Health PTE., Ltd.
General Hospital · 119d
Cleared Oct 28, 2026
VERIFY RESI-TEST SWAB Protein Detection Indicator
K260822 · SDC
Steris
General Hospital · 229d
Cleared Oct 28, 2026
HALYARD* CHEMO360 Procedure Gown Tested for use with Chemotherapy Drugs (L, XXL)
K260310 · QSO
O&M Halyard, Inc.
General Hospital · 271d
Cleared Oct 22, 2026
S.I.N. Instruments Kits
K262084 · KCT
S.I.N. Implant System Ltda
General Hospital · 122d
Cleared Oct 22, 2026
Gravity Blood Sets with 200µm Filter
K260261 · FPA
B.Braun Medical, Inc.
General Hospital · 267d
Cleared Oct 21, 2026
Sol-Guard™ Safety Pull Button Collection Set
K260857 · JKA
Sol-Millennium Medical, Inc.
General Hospital · 219d
Cleared Oct 16, 2026
Endox Test Strips
K263267 · JOJ
Ibt Scientific
General Hospital · 28d
Cleared Oct 16, 2026
Carecube Negative Pressure Isolation Chamber (1BY)
K260180 · LGM
Carecubes, Inc.
General Hospital · 268d
Cleared Oct 16, 2026
Endox High Level Disinfectant
K254094 · MED
Whiteley USA, Inc.
General Hospital · 301d
Cleared Oct 14, 2026
Sterilization Cassette (CASS-1)
K262042 · KCT
Alliedstar Medical Equipment Co., Ltd.
General Hospital · 119d
Cleared Oct 09, 2026
Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler
K260080 · LJS
Medical Components, Inc.
General Hospital · 270d
Cleared Oct 06, 2026
TSK OptiXion
K262516 · QYM
Tsk Laboratory, Japan
General Hospital · 77d
Cleared Oct 06, 2026
MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit
K262043 · DXT
Bayer Medical Care, Inc.
General Hospital · 111d
Cleared Oct 02, 2026
MEDIVATORS™ ADVANTAGE NXT™ Automated Endoscope Reprocessor
K261791 · FEB
Steris
General Hospital · 126d
Cleared Oct 01, 2026
Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low...
K262208 · LZA
Yty Industry (Manjung) Sdn Bhd
General Hospital · 93d
Cleared Sep 25, 2026
Profoject™ Safety Sliding Blood Collection Set
K262215 · JKA
CMT Health PTE., Ltd.
General Hospital · 87d
Cleared Sep 25, 2026
3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)
K261992 · JOJ
Solventum US, LLC
General Hospital · 102d
Cleared Sep 18, 2026
NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501,...
K262532 · LGZ
Icu Medical
General Hospital · 58d
Cleared Sep 18, 2026
25G Huber Needle
K254095 · PTI
Martech Medical Products
General Hospital · 273d
Cleared Sep 17, 2026
MOWANA™ Auto Duo
K261266 · FMI
PENTAMASTER MEDIQ SDN BHD
General Hospital · 154d