8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
FUJI COMPUTED RADIOGRAPHY DUAL SIDE READING, BOTH SIDE READING, FCR 5501D DUAL SIDE READER
FDA 510(k)
FDA Class 2
·Radiology
GYNECARE X-TRACT MORCELLATOR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code HET·June 8, 2006
IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE
FDA 510(k)
FDA Class 2
·Hematology
TMI LW-100 PULSED DOPPLER SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
PELVILACE BIOURETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTL·March 1, 2013
HUDSON LARGE VOLUME NEBULIZER
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code CAF·January 12, 2011
REVO MRI SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWP·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