7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
PERITONEAL DIALYSIS CYCLER MODEL PDC1000
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Intra.Ox 2.0 Handheld Tissue Oximeter
FDA 510(k)
FDA Class 2
·Cardiovascular
MC-245, MC-246, MC-247, MC-341, MC-343, MC-344
FDA 510(k)
FDA Class 2
·General Hospital
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 6, 2014
CAPSUREFIX NOVUS MRI
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code NVN·October 15, 2012
ISYMM ASPHERIC INTRAOCULAR LENS
FDA Adverse Event
Malfunction
·HOYA SURGICAL OPTICS, INC.·Product code HQL·August 4, 2010
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025