FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
2641–2664 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 05, 2025
3D-SHAPER
K251022 · KGI
3D-Shaper Medical S.L
Radiology · 156d
Cleared Sep 05, 2025
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with...
K250575 · JWY
Thermo Fisher Scientific
Microbiology · 191d
Cleared Sep 05, 2025
WatchPAT400 (WP400)
K250460 · MNR
Itamar Medical , Ltd.
Anesthesiology · 199d
Cleared Sep 05, 2025
Ureteral Access Sheath
K250132 · FED
Zhejiang Yigao Medical Technology...
Gastroenterology & Urology · 231d
Cleared Sep 05, 2025
All-Suture Dual Anchor System
K250095 · MBI
Suturetech, Inc.
Orthopedic · 234d
Cleared Sep 05, 2025
High Pressure Tubing
K244038 · DXT
Shandong Int Medical Instruments Co.,...
General Hospital · 249d
Cleared Sep 05, 2025
pREBOA-PRO Catheter
K243795 · MJN
Prytime Medical Devices, Inc.
Cardiovascular · 269d
Cleared Sep 04, 2025
KALA MINI 2.0 (KALA-04)
K251781 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 85d
Cleared Sep 04, 2025
NextAR(TM) Shoulder Platform
K251737 · SBF
Medacta International S.A.
Orthopedic · 90d
Cleared Sep 04, 2025
Fluido® AirGuard System
K251733 · LGZ
The Surgical Company International BV...
General Hospital · 90d
Cleared Sep 04, 2025
Careverse CoronaryDoc (Careverse CoronaryDoc)
K251656 · QIH
Careverse Technology Pte. , Ltd.
Radiology · 97d
Cleared Sep 04, 2025
Intense Pulsed Light Therapy Device (MMABM-1)
K251545 · ONF
Micowey Medical Equipment (Guangxi)...
General & Plastic Surgery · 107d
Cleared Sep 04, 2025
Rapid Obstructive Hydrocephalus, Rapid OH
K251533 · QAS
Ischemaview, Inc.
Radiology · 108d
Cleared Sep 04, 2025
Symani Surgical System
K251510 · SAQ
Medical Microinstruments, Inc.
General & Plastic Surgery · 111d
Cleared Sep 04, 2025
EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01)
K251463 · DQK
Abbott Medical
Cardiovascular · 115d
Cleared Sep 04, 2025
Endoskeleton™ Interbody Systems
K251444 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 118d
Cleared Sep 04, 2025
Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )
K251438 · EHD
Guilin Woodpecker Medical Instrument...
Radiology · 118d
Cleared Sep 04, 2025
Mobile Laser Unit (1001-N2)
K251298 · ONO
Clinical Laserthermia Systems, AB
Neurology · 129d
Cleared Sep 04, 2025
Image Suite
K251168 · LLZ
Carestream Health, Inc.
Radiology · 142d
Cleared Sep 04, 2025
Ball Joint Guide Array (66295)
K250893 · HAW
Bayer Medical Care, Inc.
Neurology · 163d
Cleared Sep 04, 2025
Optina-4C (MHRC-C1N)
K250770 · HKI
Optina Diagnostics, Inc.
Ophthalmic · 175d
Cleared Sep 04, 2025
Oniris
K250353 · LRK
Oniris
Dental · 209d
Cleared Sep 04, 2025
Dose+ (1.0)
K250064 · MUJ
Mvision AI OY
Radiology · 237d
Cleared Sep 04, 2025
LIBERTY Endovascular Robotic System (LIBERTYOS)
K243789 · DXX
Microbot Medical , Ltd.
Cardiovascular · 269d