13 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire
FDA 510(k)
FDA Class 2
·Cardiovascular
HairCheck-DT (Cocaine)
FDA UDI
Quest Diagnostics·00868586000216·HairCheck-DT (Cocaine) is an ELISA test kit use...
DISCOVERY NM 750B
FDA 510(k)
FDA Class 1
·Radiology
LCCS INSULATED SPINAL NEEDLE (RF CANNULA)
FDA 510(k)
FDA Class 2
·Neurology
ORS-300N SOLUTION WARMER DRAPE
FDA Adverse Event
Malfunction
·MICROTEK DOMINICANA, S.A.·Product code LHC·August 2, 2016
WARMER DRAPE
FDA Adverse Event
Malfunction
·MICROTEK DOMINICANA, S.A.·Product code LHC·February 29, 2016
CAPSUREFIX NOVUS MRI
FDA Adverse Event
Injury
·MPRI·Product code NVN·June 7, 2013
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 23, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
STARDRIVE SCREWDRIVER SHAFT T8 105MM
FDA Adverse Event
Malfunction
·SYNTHES SELZACH·Product code KWQ·September 27, 2016
URETERAL BRUSH BIOPSY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FDX·November 15, 2023
URETERAL BRUSH BIOPSY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FDX·January 7, 2022
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023