7 results
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21ms
·
Sources: EU EUDAMED, US FDA
REMOVE ADHESIVE REMOVER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
STORM-BASE 2.0
FDA 510(k)
FDA Class 2
·Radiology
Benesta Medical Sterilization Tray
FDA 510(k)
FDA Class 2
·General Hospital
HT70 PLUS VENTILATOR
FDA Adverse Event
Injury
·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·June 9, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·January 2, 2013
COROX OTW 85-BP
FDA Adverse Event
Injury
·BIOTRONIK SE & CO KG·Product code NKE·November 1, 2010
Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 8, 2017