Search FDA 510(k) Database

6,435 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
8089–8112 of 174,061
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
Cleared Sep 11, 2023
TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw System
K231504 · HWC
Vilex, LLC
Orthopedic · 110d
Cleared Sep 11, 2023
SiteRite™ 9 Ultrasound System
K231283 · IYO
Bard Access Systems, Inc. (C.R. Bard,...
Radiology · 131d
Cleared Sep 11, 2023
Change Healthcare Cardiology Hemodynamics™
K230881 · MWI
Change Healthcare Israel , Ltd.
Cardiovascular · 165d
Cleared Sep 11, 2023
Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture...
K230517 · MBI
Jarmon Medical, LLC (Dba Legends...
Orthopedic · 196d
Cleared Sep 11, 2023
Planar LED mate
K230362 · OHT
Shenzhen Leaflife Technology Co., Ltd.
General & Plastic Surgery · 213d
Cleared Sep 11, 2023
i-STAT G cartridge with the i-STAT 1 System
K223755 · CGA
Abbott Point of Care, Inc.
Chemistry · 270d
Cleared Sep 09, 2023
Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software...
K223864 · HAW
Brainlab AG
Neurology · 260d
Cleared Sep 08, 2023
CorVista® System
K232686 · QXX
Corvista Health, Inc.
Cardiovascular · 7d
Cleared Sep 08, 2023
Q-FIX ULTRA All-Suture Anchor
K232457 · MBI
Smith & Nephew
Orthopedic · 25d