11 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BriefCase
FDA 510(k)
FDA Class 2
·Radiology
Avex CX
FDA UDI
ULTRADENT PRODUCTS, INC.·00883205108067·Avex CX .018 LL5 (-17°T 2°A)
HAWKEYE™ Vertebral Body Replacement (VBR)
FDA UDI
Choice Spine, LP·00840996101028·VBR,SPACER,12X14X43,0 DEG
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551113874·HALO, CTLSO VEST SMALL, COOLMAX LINER, 1211-1 M...
LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
LOQTEQ Distal Lateral Femur Plate 4.5 System
FDA 510(k)
FDA Class 2
·Orthopedic
PUMP MMT-722NAB PRDGM INS V2.2 BL EN
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·October 23, 2008
FOUNDATION KNEE
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code JWH·August 2, 2011
GYNECARE GYNEMESH* PS
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTO·July 9, 2013
UROSKOP Omnia Max. Model Number: 10762473
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·June 25, 2025
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019