15 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CD HORIZON Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·December 13, 2023
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·December 15, 2023
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·December 14, 2023
OrthoMedFlex
FDA UDI
ORTHOMEDFLEX LLC·M7161121522480·Bridgeback Acetabular Reamer, Size 48mm
Acetabular Reamers
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215039028·
DORSAL NAIL PLATE, ANATOMICAL
FDA 510(k)
FDA Class 2
·Orthopedic
EXCELLA II SPINAL SYSTEM MODEL EC2-00
FDA 510(k)
FDA Class 2
·Orthopedic
STEM: AMISTEM H HA COATED STD STEM SIZE 3
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 28, 2023
PELVICOL ACELLULAR COLLAGEN MATRIX
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE·Product code FTL·March 5, 2013
EON RECHARGEABLE IPG
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 22, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
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