9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
JOHNSON & JOHNSON O.B. TAMPONS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
EMSYS SHL MLTHOLE 56
FDA Adverse Event
Injury
·DEPUY IRELAND - 3015516266·Product code LPH·September 25, 2025
VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX
FDA 510(k)
FDA Class 2
·Orthopedic
INSIGHT GENESIS
FDA 510(k)
FDA Class 2
·Neurology
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·November 6, 2007
SENSIA S
FDA Adverse Event
Malfunction
·MEDTRONIC S.A.·Product code NVZ·October 31, 2012
PROMUS ELEMENT? PLUS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·May 15, 2014
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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