9 results
·
25ms
·
Sources: EU EUDAMED, US FDA
LISTER BANDAGE SCISSORS 7 & 1/2
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BIOFUSIONARY BEBE
FDA 510(k)
FDA Class 2
·Physical Medicine
BACT/ALERT SN CULTURE BOTTLE
FDA 510(k)
FDA Class 1
·Microbiology
Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 782146
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 28, 2025
SYMBIQ SINGLE CHANNE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·April 16, 2014
KING SEPTEMS
FDA Adverse Event
Malfunction
·KING SEPTEMS·Product code LMA·November 1, 2012
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·June 5, 2015
BACT/ALERT I NST 100 BTLS - 259785
FDA Adverse Event
Malfunction
·BIOMÉRIEUX INC.·Product code MDB·March 4, 2024
Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 782146
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 13, 2025