8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SHOULDER MICROSTRUCTURED HUMERAL PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
NA
FDA UDI
STERIS CORPORATION·10724995152496·The Vis-U-All High Temperature Heat Seal Steril...
WHEELCHAIR PATIENT RESTRAINTS
FDA 510(k)
FDA Class 1
·Physical Medicine
RES TRAXX ONLINE, MODEL: R14
FDA 510(k)
FDA Class 2
·Anesthesiology
SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 1, 2015
ADVANTA 2 BED
FDA Adverse Event
Malfunction
·HILLROM DE MEXICO S DE RL DE CV·Product code FNL·February 13, 2014
SETROX S 53
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVZ·November 16, 2012
Vis-U-All High Temp 8"x16" Heat Seal Pouch 100 pouches per box; 9 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
FDA Enforcement
Class II
·Terminated·Steris Corporation·March 7, 2018