8 results
·
28ms
·
Sources: EU EUDAMED, US FDA
A10 ULTRASCOPE RECORDER
FDA 510(k)
FDA Class 1
·Cardiovascular
FUSON BONE PLUG, RADIOPAQUE
FDA 510(k)
FDA Class 2
·Orthopedic
NEEDLE, WITH FILTER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
LENTULO RA 25MM 1
FDA Adverse Event
Malfunction
·MAILLEFER INSTRUMENTS HOLDING SARL·Product code EKS·March 17, 2025
PUMP MMT-722CAS PRDGM INS V2.2 SK EN PR
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·October 29, 2010
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 28, 2012
UNKNOWN DEPUY SROM ACETABULAR LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWA·June 24, 2014
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020