Search FDA 510(k) Devices

5,427 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
1297–1320 of 174,061
Cleared Oct 27, 2025
cvi42 Coronary Plaque Software Application
K251027 · QIH
Circle Cardiovascular Imaging, Inc.
Radiology · 208d
Cleared Oct 27, 2025
OsteoCentric Navigated Instruments System
K250520 · OLO
Osteocentric Technologies, Inc.
Orthopedic · 248d
Cleared Oct 27, 2025
TECHFIT Patient-Specific Cranial System
K250297 · GWO
Techfit Digital Surgery, Inc.
Neurology · 269d
Cleared Oct 24, 2025
Expandable Titanium PLIF/TLIF System
K253377 · MAX
Spectrum Spine, Inc.
Orthopedic · 24d
Cleared Oct 24, 2025
CD Horizon™ Spinal System
K253335 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 24d
Cleared Oct 24, 2025
CoaguChek XS Plus System
K253188 · GJS
Roche Diagnostics
Hematology · 28d
Cleared Oct 24, 2025
Cryon-X Cold Compression
K253150 · IRP
Jkh Health Co., Ltd.
Physical Medicine · 29d
Cleared Oct 24, 2025
Infinity™ OCT System
K253129 · NKG
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Oct 24, 2025
Parietene™ Flat Sheet Mesh
K253125 · FTL
Medtronic - Sofradim Production
General & Plastic Surgery · 29d
Cleared Oct 24, 2025
AngioVac Cannula
K253106 · DWF
AngioDynamics, Inc.
Cardiovascular · 30d
Cleared Oct 24, 2025
Fule Spinal Fixation System
K252730 · NKB
Beijing Fule Science & Technology...
Orthopedic · 57d
Cleared Oct 24, 2025
Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)
K252646 · FCG
Olympus Medical Systems Corp.
Gastroenterology & Urology · 64d
Cleared Oct 24, 2025
LumiGuide Equipment R2.1
K252645 · DQK
Philips Medical Systems Nederland B.V.
Cardiovascular · 64d
Cleared Oct 24, 2025
Glucose2
K252357 · CFR
Abbott Ireland
Chemistry · 87d
Cleared Oct 24, 2025
CoroFlow Cardiovascular System
K252238 · DQK
Coroventis Research AB
Cardiovascular · 99d
Cleared Oct 24, 2025
Triathlon® Total Knee System - Triathlon® Gold Femoral Components
K252044 · MBH
Howmedica Osteonics Corp., Dba...
Orthopedic · 116d
Cleared Oct 24, 2025
Arctic Sun Temperature Management System (Model 5000)
K251974 · DWJ
Medivance, Inc.
Cardiovascular · 120d
Cleared Oct 24, 2025
Azurion R3.1
K251827 · OWB
Philips Medical Systems B.V.
Radiology · 133d
Cleared Oct 24, 2025
Hushd Pro Z-Link
K251784 · LRK
Good Sleep CO Pte , Ltd.
Dental · 135d
Cleared Oct 24, 2025
Mobile X-ray unit (!M1)
K251710 · IZL
Solutions For Tomorrow AB
Radiology · 143d
Cleared Oct 24, 2025
VersaD Delivery Catheter
K251372 · QJP
Unity Medical, Inc.
Neurology · 175d
Cleared Oct 24, 2025
Vesalio Peripheral System
K251312 · QEZ
Vesalio, Inc.
Cardiovascular · 179d
Cleared Oct 24, 2025
Syngo Carbon Clinicals (VA41)
K251059 · QIH
Siemens Healthineers AG
Radiology · 203d
Cleared Oct 24, 2025
Atalante X
K250904 · PHL
Wandercraft SAS
Neurology · 212d