11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STUART TITANIUM SURGICAL MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PYRAMESH® IMPLANT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code EZX·July 17, 2014
PYRAMESH IMPLANT SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code EZX·December 9, 2016
Twin Transfer Set
FDA UDI
Fresenius Kabi AG·04250273756043·For transition of irrigation solution.
FORZA
FDA UDI
Orthofix US LLC·18257200078233·NERVE ROOT RETRACTOR
FSC 2
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MasteRad MX30
FDA 510(k)
FDA Class 2
·Radiology
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 3, 2014
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·October 17, 2010
LIGASURE ADVANCE PISTOL GRIP
FDA Adverse Event
Malfunction
·COVIDIEN LP·Product code GEI·November 21, 2012
SmartPath to dStream for 1.5T-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: 781260
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021