9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VIRAGE OCT SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ELATION® MB
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K133551621·ELATION® MB Base Rx 018 UL/5-5 CS-BC HK
ELATION® MB
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K133552621·ELATION® MB Base Rx 022 UL/5-5 CS-BC HK
SYNTHES (USA) LCP DYNAMIC HELICAL HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE)
FDA 510(k)
FDA Class 2
·Dental
FUJIFILM BALLOON BS-4
FDA Adverse Event
Injury
·FUJIFILM CORPORATION·Product code FDA·January 14, 2021
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 29, 2013
RESTORE RECHARGEABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·June 15, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·August 22, 2008