7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
POROCOAT SCHATZKER II ACETABULUM
FDA 510(k)
FDA Class 2
·Cardiovascular
Renovis Anterior Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
ISE COMPENSATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER MANUFACTURING FACILITY·Product code FKX·June 5, 2014
M2A-MAGNUM MODULAR HEAD 48MM HEAD DIAMETER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·November 30, 2012
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 29, 2010
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015