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
361–384 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 18, 2024
Klockner Kits
K243128 · KCT
SOADCO, S.L.
General Hospital · 79d
Cleared Dec 18, 2024
Lyka® PORT Needle Free Access Device (4170Y)
K241058 · FPA
Quest Medical, Inc.
General Hospital · 244d
Cleared Dec 17, 2024
Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology,...
K242558 · LZA
O&M Halyard, Inc.
General Hospital · 111d
Cleared Dec 17, 2024
Autoclave Indicator Tape
K241036 · JOJ
Jiangmen New Era External Use Drug...
General Hospital · 245d
Cleared Dec 12, 2024
Terragene® Bionova® Photon Process Challenge Device with unique-point...
K242453 · FRC
Terragene S.A.
General Hospital · 115d
Cleared Dec 06, 2024
SmartSiteTM Vented Vial Access Device
K243486 · LHI
Yukon Medical, LLC
General Hospital · 28d
Cleared Dec 04, 2024
Chemical Indicator for enspire CLCSPS (LCC015)
K243475 · JOJ
STERIS Corporation
General Hospital · 26d
Cleared Dec 02, 2024
enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System
K243433 · FEB
STERIS Corporation
General Hospital · 27d
Cleared Dec 02, 2024
GripMate
K243232 · KZH
Synthon Hispania S.L.
General Hospital · 54d
Cleared Nov 27, 2024
Remunity System
K243354 · QJY
Deka Research & Development Corp.
General Hospital · 29d
Cleared Nov 27, 2024
PowerLoc™ Max Power Injectable Infusion Set
K241353 · PTI
Bard Access Systems, Inc.
General Hospital · 198d
Cleared Nov 27, 2024
SV Spectrum MRC Central Venous Catheter
K241115 · FOZ
Spectrum Vascular
General Hospital · 218d
Cleared Nov 25, 2024
3M™ Attest™ Super Rapid Readout Biological Indicator 1493
K242538 · FRC
3M Company
General Hospital · 91d
Cleared Nov 20, 2024
SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe...
K242291 · QNQ
Sol-Millennium Medical, Inc.
General Hospital · 110d
Cleared Nov 19, 2024
CerroZone Mini
K242102 · FRF
Cerrozone, LLC
General Hospital · 124d
Cleared Nov 14, 2024
Besmed Bacterial Filter and HMEF
K241339 · CAH
Besmed Health Business Corp
General Hospital · 185d
Cleared Nov 12, 2024
Aurelia Surgical Mask ASTM Level-3 (2130)
K242502 · FXX
Supermax Healthcare Canada-Supermax...
General Hospital · 82d
Not Cleared Nov 12, 2024
VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator
DEN230085 · SDC
Steris
General Hospital · 330d
Cleared Nov 05, 2024
MEDRAD Centargo CT Injection System
K241849 · IZQ
Imaxeon Pty, Ltd.
General Hospital · 131d
Cleared Nov 05, 2024
InfuLife
K240624 · MEB
First Medical Source, LLC
General Hospital · 245d
Cleared Nov 04, 2024
CDB Hospital ® Sterilization Wrap (70 gsm)
K240438 · FRG
Comercializadora Brever
General Hospital · 264d
Cleared Nov 01, 2024
BD Vacutainer® One Use Holder
K242320 · JKA
Becton, Dickinson and Company
General Hospital · 88d
Cleared Oct 31, 2024
PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim...
K242328 · LJT
Bard Access Systems, Inc.
General Hospital · 86d
Cleared Oct 30, 2024
Wearable Digital Thermometer (T31)
K240333 · FLL
Guangdong Genial Technology Co., Ltd.
General Hospital · 268d