FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: 2026–2026 ×
2,517 results
241–264 of 2,517
Search insights Median review: 135d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Sep 11, 2026
MICSI-PET
K261305 · KPS
Microstructure Imaging, Inc.
Radiology · 144d
Cleared Sep 11, 2026
KOWA FM-600
K261255 · MYC
Kowa Company, Ltd. Chofu Factory
Ophthalmic · 148d
Cleared Sep 11, 2026
ANTERION
K261019 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 168d
Cleared Sep 11, 2026
Single Use Ureteral Access Sheath
K260410 · FED
Zhejiang Chuangxiang Medical...
Gastroenterology & Urology · 214d
Cleared Sep 11, 2026
DRIM-Nail System
K260115
41Medical AG
Orthopedic · 240d
Cleared Sep 11, 2026
GSPE Spacer
K260063 · JWH
The General Hospital Corporation,...
Orthopedic · 246d
Cleared Sep 11, 2026
Mint ACE Pump
K260001 · QFG
Beta Bionics, Inc.
Chemistry · 252d
Cleared Sep 11, 2026
Potenza Prime
K254185 · GEI
Jeisys Medical Incorporated
General & Plastic Surgery · 262d
Cleared Sep 11, 2026
Disposable Sterile Skull Drill (LZ)
K254177 · HBF
Guizhou Zirui Technology Co., Ltd.
Neurology · 262d
Cleared Sep 11, 2026
Surgical Power System
K254174 · HBC
Guizhou Zirui Technology Co., Ltd.
Neurology · 262d
Cleared Sep 11, 2026
Ecomed Disposable Administration Sets
K254123 · FPA
Ecomed Solutions, LLC
General Hospital · 266d
Cleared Sep 11, 2026
Wearable ECG Recorder (YMHeart XY-12)
K254119 · MWJ
Shenzhen Xinyan Medical Technology...
Cardiovascular · 266d
Cleared Sep 11, 2026
BoneVue
K254072 · KGI
Curvebeam AI / Curvebeam, LLC
Radiology · 267d
Cleared Sep 11, 2026
Extroducer Infusion Catheter System
K254051 · KRA
SmartWise Sweden AB
Cardiovascular · 268d
Cleared Sep 11, 2026
SkinSmart Antimicrobial HydroGel
K254041 · FRO
Magic Science Supply, LLC
General & Plastic Surgery · 269d
Cleared Sep 11, 2026
Venti-Trach Tracheostomy Tube (570 Series)
K253063 · BTO
Vitaltec Corporation
Anesthesiology · 354d
Cleared Sep 10, 2026
Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)
K262426 · GEX
Wuhan Pioon Technology Co., Ltd.
General & Plastic Surgery · 56d
Cleared Sep 10, 2026
EVOLUTION MPX™ Total Knee System
K262293 · JWH
Suzhou Microport Orthorecon Co., Ltd.
Orthopedic · 65d
Cleared Sep 10, 2026
Cerasmart Forte
K262202 · EBF
GC America, Inc.
Dental · 73d
Cleared Sep 10, 2026
4K Camera Head OLYMPUS CH-S700-08-LB
K262079 · FET
Olympus Medical Systems Corp.
General & Plastic Surgery · 80d
Cleared Sep 10, 2026
Upper Arm Blood pressure monitor (BP7155D)
K261929 · DXN
Omron Healthcare, Inc.
Cardiovascular · 93d
Cleared Sep 10, 2026
Quicktome Software Suite
K261795 · QIH
Omniscient Neurotechnology Pty, Ltd.
Radiology · 104d
Cleared Sep 10, 2026
ACUNAV Luxera 4D ICE Catheter
K261696 · OBJ
Siemens Medical Solutions USA, Inc.
Cardiovascular · 111d
Cleared Sep 10, 2026
Diode Laser Therapy System
K261562 · GEX
Sanhe?Lefis?Electronics?Co., Ltd.
General & Plastic Surgery · 122d