10 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SLR-PLUS STANDARD AND LATERAL FEMORAL STEMS
FDA 510(k)
FDA Class 2
·Orthopedic
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450831908·
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 22, 2024
CD-CAL PLUS CALIBRATOR
FDA 510(k)
FDA Class 2
·Hematology
PROLONG HIGHLY CROSSLINKED POLYETHTYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 28, 2023
PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)·Product code LGW·October 26, 2022
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 1, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·September 16, 2014
PULSE GEN MODEL UNK
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·May 16, 2011