11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Mako Total Knee Application
FDA 510(k)
FDA Class 2
·Neurology
SOCORRO SMI TUNNEL RELEASE DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CYTOPHIL TISSUE MARKER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UNIVERSAL OSCILLATING SAW ATTACHMENT
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL S.A.·Product code GFA·October 9, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 5, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 15, 2011
FLEXOR URETERAL ACCESS SHEATH AND DILATORS
FDA Adverse Event
Malfunction
·COOK INC·Product code FED·January 3, 2020
FLEXOR URETERAL ACCESS SHEATH AND DILATORS
FDA Adverse Event
Malfunction
·COOK INC·Product code FED·January 2, 2020
FLEXOR URETERAL ACCESS SHEATH AND DILATORS
FDA Adverse Event
Malfunction
·COOK INC·Product code FED·January 7, 2020
Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution
FDA Enforcement
Class II
·Terminated·Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical·June 12, 2019
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026