14 results · 23ms · Sources: EU EUDAMED, US FDA

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OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)

FDA 510(k)
FDA Class 2 ·Radiology

TACVAC

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

OMNILINK .035 BILIARY STENT SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

TRUE2GO

FDA Adverse Event
Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·November 12, 2014

INDEPENDENCE IBOT 4000 MOBILITY SYSTEM

FDA Adverse Event
Other ·INDEPENDENCE TECHNOLOGY, L.L.C.·Product code IMK·September 12, 2011

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 30, 2013

SHOULDER SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·October 7, 2025

SHOULDER SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·May 5, 2026

GLENOID RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·October 15, 2025

SHOULDER SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·December 20, 2025

SHOULDER SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·October 22, 2025

GLENOID RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code PHX·May 26, 2026

SHOULDER SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·October 29, 2024

GLENOID RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·April 14, 2026