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
649–672 of 2,517
Search insights Median review: 135d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Jul 28, 2026
uMI Panvivo (uMI Panvivo M)
K261427 · KPS
Shanghai United Imaging Healthcare...
Radiology · 89d
Cleared Jul 28, 2026
V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound...
K261412 · IYN
Samsung Medison Co., Ltd.
Radiology · 89d
Cleared Jul 28, 2026
ELISIO™-HX
K261399 · QAX
Nipro Medical Corporation
Gastroenterology & Urology · 90d
Cleared Jul 28, 2026
Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and...
K260558 · KGO
Hartalega NGC Sdn. Bhd.
General Hospital · 159d
Cleared Jul 28, 2026
Giraffe™ OmniBed™ Carestation (CS1)
K260326 · FMZ
Datex-Ohmeda, Inc.
General Hospital · 179d
Cleared Jul 28, 2026
See-Mode Augmented Reporting Tool, Breast (SMART-B)
K260303 · QDQ
See-Mode Technologies Pty, Ltd.
Radiology · 179d
Cleared Jul 28, 2026
Revi System
K253651 · QXM
Bluewind Medical , Ltd.
Gastroenterology & Urology · 250d
Cleared Jul 28, 2026
BodyTom Elite (NL4000)
K253450 · JAK
NeuroLogica Corp., a Samsung Company
Radiology · 299d
Not Cleared Jul 28, 2026
CaRi-Heart
DEN250042 · SIU
Caristo Diagnostics , Ltd.
Cardiovascular · 327d
Cleared Jul 27, 2026
ND Needle Guidance System
K262474 · ITX
Accurate Access, LLC
Radiology · 10d
Cleared Jul 27, 2026
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8...
K262201 · PPN
Shockwave Medical, Inc.
Cardiovascular · 28d
Cleared Jul 27, 2026
Euphora Rapid Exchange (RX) Balloon Dilatation Catheter
K261759 · LOX
Medtronic, Ireland
Cardiovascular · 60d
Cleared Jul 27, 2026
FlexTract Deflectable-Rotational Dilator Sheath Set
K261310 · DRE
Merit Medical Systems, Inc.
Cardiovascular · 97d
Cleared Jul 27, 2026
Philips EPIQ Series Diagnostic Ultrasound System
K261211 · IYN
Philips Ultrasound, LLC
Radiology · 104d
Cleared Jul 27, 2026
Powered Aventus Thrombectomy System™
K261105 · QEZ
Inquis Medical
Cardiovascular · 115d
Cleared Jul 27, 2026
ARCHIMEDES Biodegradable Stent (Medium)
K260835 · FGE
Q3 Medical USA, LLC (C/O Q3 Medical...
Gastroenterology & Urology · 136d
Cleared Jul 27, 2026
Air Compression Massager (HY-1165)
K260529 · IRP
Xiamen High Top Electronic Technology...
Physical Medicine · 160d
Cleared Jul 26, 2026
Corsano CardioWatch 287-2 System
K261367 · MSX
Corsano Health B.V.
Neurology · 90d
Cleared Jul 26, 2026
CorVista System® with PCWP Add-On
K253576 · DQK
Analytics For Life, Inc.
Cardiovascular · 251d
Cleared Jul 25, 2026
MONARCH™ Platform (MON-000008)
K260382 · EOQ
Auris Health, Inc.
Ear, Nose, Throat · 170d
Cleared Jul 25, 2026
METICULY Patient-specific CMF solution
K253206 · JEY
Meticuly Co., Ltd.
Dental · 302d
Cleared Jul 24, 2026
TheraSphere 360™ Y-90 Management Platform
K262462 · LLZ
Boston Scientific Corporation
Radiology · 7d
Cleared Jul 24, 2026
LumenCare Azure
K262383 · JAQ
Nucletron B.V.
Radiology · 11d
Cleared Jul 24, 2026
dS FootAnkle 16Ch 1.5T
K262294 · MOS
Philips Medical Systems Nederland B.V.
Radiology · 17d