11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
HILL-ROM PATIENT ENVIRONMENTAL CONTROL SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
Supreme In-Situ Hammock Sling Long Tucks Size 2
FDA UDI
SILVALEA LIMITED·05056387435633·
Supreme In-Situ Hammock Sling Long Tucks Size 1
FDA UDI
SILVALEA LIMITED·05056387435626·
NONE
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code UNK·December 11, 2009
REPROCESSED VENODYNE SEQUENTIAL COMPRESSION SLEEVES / WRAP
FDA 510(k)
FDA Class 2
·Cardiovascular
POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
TENOR SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code KWQ·December 11, 2009
FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT
FDA Adverse Event
Malfunction
·CONVATEC INC.·Product code KNT·June 9, 2014
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010
ACTICON NEOSPINCTER
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code MIP·January 10, 2013
HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013