9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
TELECARE ISOTEC PRESSURE TRANSDUCER DOME
FDA 510(k)
FDA Class 2
·Cardiovascular
ERA® Implant Abutment Micro 0°, 3mm Cuff (C)
FDA UDI
STERNGOLD DENTAL LLC·00841549105531·Implant retained overdentures are an establishe...
ers2 - ergoline Rehabilitation System
FDA 510(k)
FDA Class 2
·Cardiovascular
ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·May 15, 2014
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·October 31, 2012
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code FTL·August 12, 2010
MENTOR TISSUE EXPANDER
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·February 4, 2019
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