Search FDA 510(k) Devices

5,386 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2025–2025 ×
3,225 results
265–288 of 3,225
Cleared Dec 04, 2025
MitraPatch Mitral Valve Repair System
K252126 · PAW
Chawla Heart Technologies, LLC
Cardiovascular · 150d
Cleared Dec 04, 2025
Spineology Navigation Instruments
K251943 · OLO
Spineology, Inc.
Orthopedic · 163d
Cleared Dec 04, 2025
nSet+ Stabilization Set [6426733]
K251257 · FPA
Np Medical
General Hospital · 225d
Cleared Dec 04, 2025
ADVIA Centaur Anti-Thyroglobulin II (aTgII)
K250816 · JNL
Siemens Healthcare Diagnostics, Inc.
Immunology · 261d
Cleared Dec 04, 2025
ASUS Ultrasound Imaging System (LU800 series)
K250791 · IYN
Asustek Computer, Inc.
Radiology · 265d
Cleared Dec 04, 2025
FFX Facet Fixation System
K250679 · MRW
Sc Medica
Orthopedic · 273d
Cleared Dec 03, 2025
VitaloJAK Clinic (Model 7100)
K253293 · DSH
Vitalograph , Ltd.
Anesthesiology · 65d
Cleared Dec 03, 2025
Bendit17 Microcatheter
K252213 · QJP
Bend IT Technologies, Ltd.
Neurology · 141d
Cleared Dec 03, 2025
HippoMind (v1.0)
K251881 · OLT
Hippoclinic
Neurology · 168d
Cleared Dec 03, 2025
Omnipod 5 algorithm
K251779 · QJI
Insulet Corporation
Chemistry · 176d
Cleared Dec 03, 2025
Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus...
K251601 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 190d
Cleared Dec 03, 2025
AVIEW Lung Nodule CAD
K251203 · OEB
Coreline Soft Co., Ltd.
Radiology · 229d
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