9 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft Tissue (17G)
FDA 510(k)
FDA Class 2
·Radiology
DANA REUSABLE TEST PACK FOR STEAM STERILIZATION
FDA 510(k)
FDA Class 2
·General Hospital
MODIFICATION TO: XIA 4.5 SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FOGARTY
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code MJN·March 24, 2025
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC SINGAPORE OPERATIONS·Product code DTB·June 8, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 24, 2011
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·October 8, 2014
VENATECH CONVERTIBLE
FDA Adverse Event
Malfunction
·B.BRAUN MEDICAL SAS·Product code DTK·January 5, 2018
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023