21 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Stereo 3D option for Vision Applications
FDA 510(k)
FDA Class 2
·Radiology
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690124283·Modular Offset Stem 13mm x 150mm x 2mm
Monobloc Hex Driver
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215076139·
COLOR CORONIS 2MP-21 AND MFCD 2321
FDA 510(k)
FDA Class 2
·Radiology
EVOLVE EPS ORTHOLOC
FDA 510(k)
FDA Class 2
·Orthopedic
PROTECTA CRT-D
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 7, 2013
COLLEAGUE PRE 1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·April 18, 2019
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·May 29, 2015
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·May 29, 2015
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·May 29, 2015
SYNERGY
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·June 1, 2015
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·May 29, 2015
SYNERGY VERSITREL
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·May 28, 2015
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·June 4, 2015
SYNERGY VERSITREL
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·June 4, 2015
Precise Treatment Table. To be used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 17, 2013
All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 12, 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