8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
ENDOCARDIAL PACING LEAD, MODEL 476-01
FDA 510(k)
FDA Class 3
·Cardiovascular
CONTRA-ANGLE HANDPIECE KOMET OS30
FDA 510(k)
FDA Class 1
·Dental
BIOMONITOR III, Remote Assistant III
FDA 510(k)
FDA Class 2
·Cardiovascular
P.F.C.* TIB STM EXT 4/5/6 30MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·May 5, 2014
CAPSUREFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 15, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 16, 2007
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024