Search FDA 510(k) Devices

5,426 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2023–2023 ×
3,347 results
1081–1104 of 3,347
Cleared Sep 13, 2023
AMSCO 600 Steam Sterilizer
K232485 · FLE
Steris
General Hospital · 28d
Cleared Sep 13, 2023
GenX-CR
K232158 · MUH
Genoray Co., Ltd.
Radiology · 55d
Cleared Sep 13, 2023
OSSIOfiber® Cannulated Trimmable Fixation Nail
K230750 · HTY
OSSIO , Ltd.
Orthopedic · 180d
Cleared Sep 13, 2023
Ultimate rTMS
K230735 · OBP
Brain Ultimate, Inc.
Neurology · 181d
Cleared Sep 13, 2023
NG Delivery Catheter
K230609 · QJP
Balt USA, LLC
Neurology · 191d
Cleared Sep 13, 2023
Lung-CAD
K223811 · MYN
Imagen Technologies, Inc.
Radiology · 267d
Cleared Sep 13, 2023
CRYOcheck Factor VIII Deficient Plasma with VWF
K222831 · GJT
Precision Biologic, Inc.
Hematology · 359d
Cleared Sep 13, 2023
AlloMap Heart Molecular Expression Testing
K221640 · OJQ
Caredx, Inc.
Chemistry · 464d
Not Cleared Sep 13, 2023
ensoETM
DEN230021 · QXV
Advanced Cooling Therapy, Inc. D/B/A...
Cardiovascular · 167d
Cleared Sep 12, 2023
XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5
K232526 · JAA
Canon Medical Systems Corporation
Radiology · 22d
Cleared Sep 12, 2023
Velacur
K232459 · IYO
Sonic Incytes
Radiology · 28d
Cleared Sep 12, 2023
Definium Pace Select
K231892 · KPR
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 76d
Cleared Sep 12, 2023
Skyway Anterior Cervical Plate System
K231766 · KWQ
Kyocera Medical Technologies Inc. (KMTI)
Orthopedic · 88d
Cleared Sep 12, 2023
Cartesion Prime (PCD-1000A/3) V10.15
K231748 · KPS
Canon Medical Systems Corporation
Radiology · 89d
Cleared Sep 12, 2023
TrueBeam, TrueBeam STx, Edge, VitalBeam
K231317 · IYE
Varian Medical Systems, Inc.
Radiology · 127d
Cleared Sep 12, 2023
Materialise Shoulder System™, Materialise Shoulder Guide and Models,...
K231112 · QHE
Materialise NV
Orthopedic · 146d
Cleared Sep 12, 2023
Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse
K231011 · HQF
Meridian AG
Ophthalmic · 155d
Cleared Sep 12, 2023
Stone Extraction Baskets
K230598 · LQR
Jiangsu Vedkang Medical Science and...
Gastroenterology & Urology · 193d
Cleared Sep 12, 2023
Ablation-fit
K222938 · QTZ
R.A.W. S.R.L
Radiology · 351d
Cleared Sep 12, 2023
Endure ETCO2/02 Nasal Cannula
K213767 · CCK
Endure Industries, Inc.
Anesthesiology · 650d
Cleared Sep 11, 2023
Venus Versa PRO System
K232192 · ONF
Venus Concept, Inc.
General & Plastic Surgery · 49d
Cleared Sep 11, 2023
MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation
K232154 · OVD
MiRus, LLC
Orthopedic · 53d
Cleared Sep 11, 2023
Vantage® Total Ankle System
K232002 · HSN
Exactech, Inc.
Orthopedic · 68d
Cleared Sep 11, 2023
VERIFY Spore Test Strip for S40 Sterilant Concentrate
K231746 · OVY
STERIS Corporation
General Hospital · 88d