17 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Xenco Medical Cervical Interbody System, Xenco Medical Lumbar Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
AGC KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304242999·
TWISTER SIDE FIRE OPTICAL FIBER DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CC
FDA 510(k)
FDA Class 2
·Radiology
SHIDEN HP
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·June 4, 2019
SECURE 3 MED/SURG BEDOBS 01/13
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·June 8, 2013
PERFORATOR DRIVER WITH HUDSON END
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBE·October 8, 2014
ENDURANT STENT GRAFT SYSTEM
FDA Adverse Event
Death
·MEDTRONIC CARDIOVASCULAR IRELAND·Product code MIH·June 23, 2011
SHIDEN HP
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·March 1, 2024
SHIDEN
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·July 10, 2020
DIVA
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·July 7, 2020
DIVA
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·July 7, 2020
SHIDEN HP
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·April 18, 2022
SHIDEN
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·September 2, 2021
SHIDEN
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·January 6, 2022
VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
FDA Enforcement
Class I
·Ongoing·Ventec Life Systems, Inc.·May 13, 2026
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