7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
COROMETRICS 500 INFANT MONITOR
FDA 510(k)
FDA Class 2
·Anesthesiology
VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor
FDA 510(k)
FDA Class 2
·Radiology
ZILVER PTX 35 DRUG-ELUTING STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code NIU·May 20, 2014
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 27, 2012
RECONSTITUTION DEVICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code FPA·October 1, 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