8 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIOMET FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Biomet® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304233010·
5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ROSA SURGICAL DEVICE
FDA 510(k)
FDA Class 2
·Neurology
GMK SPHERE FEMUR
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 2, 2019
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 4, 2014
LAMITRODE TRIPOLE 16
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 28, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·June 27, 2011