28 results · 25ms · Sources: EU EUDAMED, US FDA

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AmCAD-UT

FDA 510(k)
FDA Class 2 ·Radiology

SOLO-SAFE SAFETY SYRINGE, SIZE-3CC

FDA 510(k)
FDA Class 2 ·General Hospital

MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·August 26, 2024

REVERSE SHOULDER SYSTEM 04.01.0124 HUMERAL REVERSE HC LINER Ø39/+6MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·July 13, 2023

SHOULDER SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·October 24, 2024

SHOULDER - TINBN COATING

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KWS·July 30, 2025

SHOULDER - TINBN COATING

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KWS·September 17, 2025

SHOULDER SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·May 19, 2025

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 27, 2014

CAPSUREFIX NOVUS

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·July 3, 2013

REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 36/+0MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·September 24, 2021

SHOULDER SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·November 10, 2025

SHOULDER SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·November 18, 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·September 19, 2024

GLENOID RECONSTRUCTION SYSTEM

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

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·December 23, 2022

EMBLEM MRI S-ICD Model A219

FDA Enforcement
Class I ·Terminated·Boston Scientific Corporation·February 17, 2021