8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ADVANCE EMIT-CAD DISOPYRAMIDE CONTROL
FDA 510(k)
FDA Class 1
·Clinical Toxicology
iNSitu™ Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127023552·Full Hemisphere Reamer Size 49
MONOJECT 12ML SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
MODIFICATION TO RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, NELLCOR·Product code CBK·March 11, 2014
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·November 13, 2012
RSVR MMT-332A 10PK PRDGM 3CC 14L
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FMF·September 7, 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