12 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PASS LP Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES
FDA 510(k)
FDA Class 2
·General Hospital
ASCEND SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TRUWAVE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·April 22, 2026
TRUWAVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES DR·Product code DXO·March 27, 2025
ENSURA DR MRI SURESCAN
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NVZ·June 8, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 7, 2011
11CM ANGLE ATTACHMENT
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 8, 2014
TRUWAVE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·April 10, 2025
TRUWAVE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·September 5, 2025
ASAHI CONQUEST PRO 9-40
FDA Adverse Event
Malfunction
·ASAHI INTECC CO., LTD.·Product code DQX·April 27, 2016
ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023