8 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Vivatmo pro-S
FDA 510(k)
FDA Class 2
·Clinical Toxicology
accufit
FDA 510(k)
FDA Class 2
·Physical Medicine
VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
21 G X .75 IN BD VACUTAINER® WINGED SAFETY PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·December 3, 2017
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 11, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 12, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 23, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025