7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
INTER-OS BONE GENERATOR
FDA 510(k)
FDA Class 2
·Dental
GOOTT MULTIPURPOSE FLEXIBLE RETRACTOR (STERILE)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SE-601 SERIES ELECTROCARDIOGRAPH
FDA 510(k)
FDA Class 2
·Cardiovascular
FLEXIBEL FULGURATING ELECTRODE BALL TIP
FDA Adverse Event
Injury
·GYRUS ACMI, INC.·Product code FAS·March 1, 2013
UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·February 16, 2011
SPRINT QUATTRO SECURE S
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·August 8, 2014
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024