17 results · 28ms · Sources: EU EUDAMED, 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