10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Alevicyn SG Antimicrobial Gel
FDA 510(k)
FDA Unclassified
·Unknown
CENTERVUE DIGITAL RETINOGRAPHY SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
TI-BASE ABUTMENT, 1 CONNECT ABUTMENT
FDA 510(k)
FDA Class 2
·Dental
PROTEGE RX CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·COVIDIEN·Product code NIM·March 23, 2018
INFUSOMAT SPACE S
FDA Adverse Event
Malfunction
·B. BRAUN·Product code FRN·July 12, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 7, 2013
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·September 19, 2008
CONQUEST PRO 12 ST
FDA Adverse Event
Injury
·ASAHI INTECC CO., LTD.·Product code DQX·July 16, 2025
ASTATO XS 9-12
FDA Adverse Event
Malfunction
·ASAHI INTECC CO., LTD.·Product code DQX·June 24, 2025
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