11 results
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32ms
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Sources: EU EUDAMED, US FDA
ORION PLUS/MODIFICATION
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ORTHOTM Sera Papain
FDA UDI
ALBA BIOSCIENCE LIMITED·10758750030330·For in vitro diagnostic use only.
For use as an...
Swish™ Gold Engaging Abutment
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307115984·
(EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUM
FDA 510(k)
FDA Class 1
·Microbiology
GIANT LUMEN SAFETIP SERIES: ENDOMYOCARDIAL BIOPSY
FDA 510(k)
FDA Class 2
·Cardiovascular
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 5, 2014
RESTORE SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·January 9, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 22, 2010
VERSA-DIAL 46X18X53 HUM HEAD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBF·October 5, 2023
MD HYBRID GLENOID BASE 4MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·October 5, 2023
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015