8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
ABUSCREEN ONTRAK POS. REF. CONTROL FOR MORPHINE
FDA 510(k)
FDA Class 1
·Clinical Toxicology
MEDCARE GENERAL PURPOSE TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
C-LOOPS
FDA 510(k)UNK JUVEDERM VOLUMA
FDA Adverse Event
Injury
·ALLERGAN·Product code LMH·June 12, 2014
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·January 2, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·November 1, 2010
Total Joint Pack, part number 006358-6
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
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