9 results
·
34ms
·
Sources: EU EUDAMED, US FDA
ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE
FDA 510(k)
FDA Class 2
·Anesthesiology
ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ENA EIA KIT
FDA 510(k)
FDA Class 2
·Immunology
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·April 25, 2014
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code NBW·October 10, 2007
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
BD EMERALD 5ML SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·October 1, 2019
DELTAFILL18 10MM X 40CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·September 10, 2020
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