29 results
·
23ms
·
Sources: EU EUDAMED, US FDA
CERASORB PLUS
FDA 510(k)
FDA Class 2
·Dental
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100152111·IN-OVATION® C Base Rx 022 U5-5 CS-BC HK
Resolve® Ceramic
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K210152121·Resolve® Ceramic R022 UL 5-5 CS HK/MBT 4-5
MYSTIQUE® MB
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K110152101·MYSTIQUE® MB RT RX 022 U 5-5 CS HK
Resolve® Ceramic
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K210152811·Resolve® Ceramic M022 UL 5-5 CS BC HK
Resolve® Ceramic
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K210152111·Resolve® Ceramic R022 UL 5-5 CS BC HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100152611·IN-OVATION® C Roncone 022 U5-5 CS-BC HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100152101·IN-OVATION® C Base Rx 022 U5-5 CS HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100152001·IN-OVATION® C Base Rx 022-U5-5
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100152801·IN-OVATION® C EURO 022 U5-5 CS HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100152811·IN-OVATION® C EURO 022 U5-5 CS-BC HK
SIRONA CAD/CAM SYSTEM
FDA 510(k)
FDA Class 2
·Dental
SYNTHES VERTEBRAL SPACER TI
FDA 510(k)
FDA Class 2
·Orthopedic
TRULINK
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522101120·NIBP,CUFF,1TB,NEO1,3-6CM,SOFT
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·February 17, 2021
ONE TOUCH ULTRASMART
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·August 18, 2003
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·August 15, 2022
XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·May 20, 2013
PULSE GEN MODEL 105
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·September 25, 2014
RESTORE ADVANCED RECHARGEABLE
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·June 6, 2011