14 results · 21ms · Sources: EU EUDAMED, US FDA

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VIVO 50

FDA 510(k)
FDA Class 2 ·Anesthesiology

BREAS VIVO 60

FDA Adverse Event
Malfunction ·BREAS MEDICAL AB·Product code NOU·July 31, 2017

BREAS VIVO 60

FDA Adverse Event
Malfunction ·BREAS MEDICAL AB·Product code NOU·September 15, 2015

BREAS VIVO 60

FDA Adverse Event
Malfunction ·BREAS MEDICAL AB·Product code NOU·May 12, 2017

BREAS VIVO 60

FDA Adverse Event
Malfunction ·BREAS MEDICAL AB·Product code NOU·May 12, 2017

PAGEWRITER TC 20, 30, 50, 70

FDA 510(k)
FDA Class 2 ·Cardiovascular

DIGITAL COLOR DOPPLER ULTRASOUND IMAGAING SYSTEM; CONVEX / LINEAR PHASED ARRAY TRANSDUCER

FDA 510(k)
FDA Class 2 ·Radiology

PAGEWRITER TC 20 CARDIOGRAPH

FDA Adverse Event
Malfunction ·PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC·Product code DPS·May 17, 2021

MEDEX KIDS KIT CLOSED BLOOD SAMPLING SYSTEM

FDA Adverse Event
Malfunction ·ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.·Product code DRS·December 15, 2025

ACCOLADE PLUS TMZF HIP STEM #2

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·May 21, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 26, 2014

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code MDS·June 10, 2011

dS Breast 16ch 1.5T

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·December 4, 2024

Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

FDA Enforcement
Class I ·Ongoing·Covidien·November 8, 2023