Search FDA 510(k) Devices

5,409 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
1009–1032 of 174,061
Cleared Dec 03, 2025
Hugo™ RAS System
K250725 · SCV
Covidien, LLC
General & Plastic Surgery · 268d
Cleared Dec 03, 2025
GentleBeam (GB1000)
K250692 · JAD
Voxel Ray Solutions, LLC
Radiology · 271d
Cleared Dec 03, 2025
Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)
K250564 · FYA
Yadu Medical (Henan) Co., Ltd.
General Hospital · 280d
Cleared Dec 02, 2025
Acorn 3D Software (AC-SEG-4009)
K252103 · QIH
Mighty Oak Medical
Radiology · 152d
Cleared Dec 02, 2025
da Vinci SP Surgical System (SP1098)
K252069 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 154d
Cleared Dec 02, 2025
Disposable Endoscopic Injection Needles
K252021 · FBK
Changzhou New Med Micro-Medtech Co.,...
Gastroenterology & Urology · 155d
Cleared Dec 02, 2025
Aura Wave
K250896 · SGT
Aura Wellness, LLC
Physical Medicine · 252d
Cleared Dec 02, 2025
0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe
K250884 · NGT
Becton, Dickinson and Company
General Hospital · 253d
Cleared Dec 01, 2025
Minuteman® G6 MIS Fusion Plate
K253250 · PEK
Spinal Simplicity, LLC
Orthopedic · 63d
Cleared Dec 01, 2025
IBP cable Becton Dickinson (2606488)
K252827 · DSA
Dr?gerwerk AG & Co KGaA
Cardiovascular · 87d
Cleared Dec 01, 2025
Led Light Phototherapy Bed (Pro 450/ GY-680A)
K252786 · OLI
Shenzhen Suyzeko Limited.
General & Plastic Surgery · 90d
Cleared Dec 01, 2025
Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48)
K251696 · DQA
Unimed Medical Supplies, Inc.
Anesthesiology · 182d
Cleared Dec 01, 2025
Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08)
K251691 · DQA
Unimed Medical Supplies, Inc.
Anesthesiology · 182d
Cleared Dec 01, 2025
Cartesion Prime (PCD-1000A/3) V10.21
K251370 · KPS
Canon Medical Systems Corporation
Radiology · 213d
Cleared Dec 01, 2025
Equinoxe® Humeral Reconstruction Prosthesis
K250713 · KWT
Exactech, Inc.
Orthopedic · 266d
Cleared Nov 28, 2025
Dendrite Imaging System
K253303 · QDG
Dendrite Imaging, Inc.
General & Plastic Surgery · 60d
Cleared Nov 28, 2025
Medical Diode Laser Systems (TR-B)
K252658 · GEX
Baoding Te'Anzhou Electronic...
General & Plastic Surgery · 98d
Cleared Nov 28, 2025
CT VScore+
K252217 · JAK
Canon Medical Informatics, Inc.
Radiology · 136d
Cleared Nov 28, 2025
Sophy Mini Monopressure Valve (SM1)
K250636 · JXG
Sophysa
Neurology · 270d
Cleared Nov 27, 2025
Carriere® Motion Pro® Clear Bite Corrector
K252760 · DYW
Ortho Organizers, Inc.
Dental · 90d
Cleared Nov 26, 2025
OEC One CFD
K253269 · OXO
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 58d
Cleared Nov 26, 2025
0.014” Willow Guidewire
K253168 · MOF
Arbor Endovascular, LLC
Neurology · 61d
Cleared Nov 26, 2025
Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional...
K252405 · NLH
Surgical Instrument Service and...
Cardiovascular · 118d
Cleared Nov 26, 2025
Vanquish Water Vapor Ablation Device
K252388 · KNS
Francis Medical, Inc.
Gastroenterology & Urology · 118d