8 results
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24ms
·
Sources: EU EUDAMED, US FDA
ALBUMIN REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FORTUNE SILICONE VACUUM SUCTION, MODEL #1300
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm
FDA 510(k)
FDA Class 2
·Orthopedic
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 20, 2014
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·November 6, 2012
PUMP MMT-722LNAS PRDGM INS SK EN ML
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·August 26, 2010
Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782151; 2) 782119; 3) 781358; 4) 782107; 5) 782136
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·October 2, 2024
Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782151; 2) 782119; 3) 781358; 4) 782107; 5) 782136
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·September 3, 2024