9 results
·
22ms
·
Sources: EU EUDAMED, US FDA
SECHRIST AIR-OXYGEN MIXER & ANCILLARY
FDA 510(k)
FDA Class 2
·Anesthesiology
NONINVASIVE BLOOD PRESSURE MONITOR, MODELS MD-880B AND MD-900T
FDA 510(k)
FDA Class 2
·Cardiovascular
PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE
FDA 510(k)
FDA Class 2
·General Hospital
UNSPECIFIED PRIMARY PLUM SET
FDA Adverse Event
Malfunction
·ICU MEDICAL COSTA RICA LTD.·Product code FPA·October 3, 2024
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·May 30, 2014
ASR UNI FEMORAL IMPL SIZE 43
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·November 21, 2012
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 12, 2015
UNSPECIFIED PRIMARY PLUM SET CLAVE PORT, CLAVE Y-SITE, SECURE LOCK
FDA Adverse Event
Malfunction
·ICU MEDICAL COSTA RICA LTD.·Product code FPA·November 24, 2024
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