15 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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DURAFORM Dural Graft Implant
FDA 510(k)
FDA Class 2
·Neurology
3.5mm Flexible Drill
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215076320·
STINGRAY LP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·March 26, 2025
AUTOSURE VOICE 3 BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIP
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BD VIPER SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
PEDICLE SCREW MONOAXIAL SCREW 5X40MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·September 10, 2019
STINGRAY? LP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·May 29, 2026
ALPHA I INFLATABLE PENILE PROSTHESIS
FDA Adverse Event
Injury
·MENTOR UROLOGY, INC.·Product code FHW·April 30, 1997
SPRINT
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 7, 2013
S-ICD SYSTEM
FDA Adverse Event
Injury
·CAMERON HEALTH·Product code LWS·July 14, 2014
NDEHP MICRO 7IN EXT
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code FPK·June 27, 2011
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·January 5, 2016
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
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