8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
DAVOL SILICONE SHEATH SUMP DRAIN
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
THROMBOMAX-HS WITH CALCIUM, MODEL T6540
FDA 510(k)
FDA Class 2
·Hematology
ILLUMINATING SINUS SEEKER
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
BD DISCARDIT II SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·April 11, 2019
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·April 25, 2014
PRECISION XTRA/OPTIUM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·October 12, 2007
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·October 31, 2012
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024