10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Multitom Rax
FDA 510(k)
FDA Class 2
·Radiology
TriVerse Tibial Offset Cutting Block
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215108212·
IQ FLEX M
FDA Adverse Event
Malfunction
·FIRST SOURCE INC.·Product code IZL·May 29, 2024
SIMPLI SIMPLER IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Surgical Trays
FDA 510(k)
FDA Class 2
·General Hospital
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·March 31, 2025
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
JUMAO HEALTHCARE EQUIPMENT·Product code IOR·November 3, 2014
DISPOSABLE PURSTRING 65 INSTRUMENT
FDA Adverse Event
Injury
·USSC PUERTO RICO·Product code GDJ·August 17, 2011
PULSE GEN MODEL 101
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code LYJ·July 11, 2013
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016