17 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PROBEAT-V
FDA 510(k)
FDA Class 2
·Radiology
BD SYRINGE 5ML LL BNS
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 21, 2024
SUTRAZORB
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AXLE PEEK INTERSPINOUS FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FLEXOR RADIAL ACCESS SET
FDA Adverse Event
Injury
·COOK, INC.·Product code DYB·April 13, 2015
BIPOL LEAD MODEL 300
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·October 8, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 7, 2013
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 27, 2011
INSTINCT JAVA SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code MNH·October 30, 2019
INSTINCT JAVA SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code MNH·October 30, 2019
INSTINCT JAVA SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code MNH·October 30, 2019
INSTINCT JAVA ROD, UNKNOWN
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code MNH·October 30, 2019
INSTINCT JAVA ROD, UNKNOWN
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code MNH·October 31, 2019
FLEXOR RADIAL ACCESS SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·July 12, 2016
INSTINCT JAVA SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code MNH·October 31, 2019
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 9, 2014
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023