10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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eVox System
FDA 510(k)
FDA Class 2
·Neurology
PF4 IGG
FDA Adverse Event
Malfunction
·IMMUCOR GTI DIAGNOSTICS·Product code GWG·January 16, 2015
PF4 IGG
FDA 510(k)
FDA Class 2
·Hematology
GYMFORM DUAL FLEX BELT MODEL WB-162
FDA 510(k)
FDA Class 2
·Physical Medicine
CLEARVIEW UTERINE MANIPULATOR
FDA Adverse Event
Injury
·CLINICAL INNOVATIONS, LLC·Product code LKF·June 11, 2024
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 15, 2014
ASR UNI FEMORAL IMPL SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·June 17, 2013
FOGARTY ARTERIAL EMBOLECTOMY CATHETER
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DXE·July 22, 2011
LOGIC CR TIB INSERT STD, SZ 2, 13MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·July 13, 2023
Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021