Search FDA 510(k) Devices

5,459 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
1753–1776 of 174,061
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
Cleared Sep 04, 2025
Apollo TMS Therapy System
K243700 · OBP
Mag & More GmbH
Neurology · 279d
Cleared Sep 03, 2025
Tempus Pixel
K252539 · QIH
Arterys, Inc.
Radiology · 22d
Cleared Sep 03, 2025
Kinos Total Ankle System
K252454 · HSN
Restor3d
Orthopedic · 30d
Cleared Sep 03, 2025
BruxZir® NOW
K252446 · EIH
Prismatik Dentalcraft, Inc.
Dental · 30d
Cleared Sep 03, 2025
AquaCast Mask
K252174 · IYE
Blessing Cathay Corporation
Radiology · 54d
Cleared Sep 03, 2025
NeurotriS (SX2500)
K251909 · NFO
A-1 Engineering
Neurology · 75d