10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
STATVIEW
FDA 510(k)
FDA Class 1
·Radiology
Bosworth Copaliner
FDA UDI
Harry J Bosworth Company·H66809215271·Copaliner Solvent
Supreme In-Situ Hammock Sling Short Tucks Size 1
FDA UDI
SILVALEA LIMITED·05056387435602·
Supreme In-Situ Hammock Sling Short Tucks Size 2
FDA UDI
SILVALEA LIMITED·05056387435619·
SECTRA OSTEOPOROSIS PACKAGE
FDA 510(k)
FDA Class 2
·Radiology
WI-FI BODY SCALE
FDA 510(k)
FDA Class 2
·Cardiovascular
FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT
FDA Adverse Event
Malfunction
·CONVATEC INC.·Product code KNT·June 9, 2014
MONARC SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code OTN·January 10, 2013
CONCERTO II CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·December 13, 2010
HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013