7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ASTRO-MED ASC-951 PRESSURE PROCESSOR
FDA 510(k)
FDA Class 2
·Cardiovascular
ABL300 ACID BASE LABORATORY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ADULT INCONTINENCE PAD
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 23, 2014
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·November 9, 2010
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·December 27, 2012
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021