7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
DAC-CEL T4
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MODEL 738 BIRT-A-PAD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Andorate Auxiliary Water Connector, Andorate Valves Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 5, 2014
SPRINT QUATTRO
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 15, 2012
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·August 2, 2010
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025