16 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CREAM, SIGNA
FDA 510(k)
FDA Class 2
·Neurology
OVATION®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K82055261·OVATION® Base Rx SP 022 UL/5-5 CS-BC DHK
MICROARCH®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K72055121·MICROARCH® Base Rx 018 UL/5-5 CS-BC HK
MICROARCH®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K72055131·MICROARCH® Base Rx 018 UL/5-5 CS HK
MICROARCH®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K72055301·MICROARCH ® BI-DIMENSIONAL® UL/5-5 CS HK
MICROARCH®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K72055231·MICROARCH® Base Rx 022 UL/5-5 CS HK
MICROARCH®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K72055081·MICROARCH® Base Rx 022 U/L 5-5 CS HK OB
OVATION®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K82055241·OVATION® Base Rx 022 UL/5-5 CS-BC MHK
MICROARCH®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K72055221·MICROARCH® Base Rx 022 UL/5-5 CS-BS HK
OVATION®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K82055221·OVATION® Base Rx 022 UL/5-5 CS-BC DHK
MODEL PC-860 FETAL DOPPLER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SECULOK ACP System
FDA 510(k)
FDA Class 2
·Orthopedic
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·April 30, 2014
ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM
FDA Adverse Event
Injury
·MAKO SURGICAL·Product code HAW·October 2, 2012
ACCU-CHEK ® SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE, INC.·Product code LZG·May 19, 2015
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025