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

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MODIFICATION TO: GIRAFFE AND PANDA WARMER

FDA 510(k)
FDA Class 2 ·General Hospital

Amara View

FDA UDI
Respironics, Inc.·00606959009370·mask cushion

MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS

FDA 510(k)
FDA Class 2 ·Anesthesiology

UNIQUE AMBULATORY EEG

FDA 510(k)
FDA Class 2 ·Neurology

TRIMA ACCEL

FDA Adverse Event
Malfunction ·TERUMO BCT·Product code GKT·May 2, 2013

GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

FDA Adverse Event
Death ·AV-TEMECULA-CT·Product code MAF·September 15, 2014

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 26, 2011

BD TRUCOUNT TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 13, 2021

Philips Respironics Amara View Minimal Contact Full-Face Mask

FDA Enforcement
Class I ·Ongoing·Philips Respironics, Inc.·October 12, 2022

BD TRUCOUNT TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code GKZ·July 15, 2021

BD MULTITEST¿

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·February 9, 2024

BD MULTITEST¿

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code GKZ·March 15, 2024

BD MULTITEST¿

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·March 15, 2024

BD MULTITEST¿

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code GKZ·March 15, 2024

BD TRUCOUNT¿ TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 2, 2025