8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SPHERISTEM TOTAL HIP PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
DERMA SCIENCES CALCIUM ALGINATE DRESSING WITH ANTIMICROBIAL SILVER (ALGICELL AG)
FDA 510(k)
FDA Unclassified
·Unknown
Scone Mask
FDA 510(k)
FDA Class 2
·Anesthesiology
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 7, 2014
ACUVUE OASYS BRAND W/HYDRACLEAR PLUS
FDA Adverse Event
Injury
·VISTAKON·Product code LPL·October 5, 2012
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code NBW·July 16, 2007
Oxoid Agglutinating Sera, Salmonella 9-0 R30957301
FDA Enforcement
Class II
·Ongoing·Remel Europe Ltd.·April 29, 2026
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024