7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
VENTREZYME PAP KIT IMMUNOASSAY PROSTATIC
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Palladian Lumbar Pedicle Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR ERTAPENEM
FDA 510(k)
FDA Class 2
·Microbiology
LCS COMPLETE FEM POR L STD
FDA Adverse Event
Injury
·DEPUY IRELAND REG. # 9616671·Product code NJL·June 2, 2014
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·November 21, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·September 24, 2010
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021