140 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MYSTIQUE® MB
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K110152101·MYSTIQUE® MB RT RX 022 U 5-5 CS HK
SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS
FDA 510(k)
FDA Class 2
·General Hospital
DULEX
FDA UDI
Davol Inc.·00801741011801·Bard Dulex Mesh
GastroFlex™UHD-C
FDA UDI
MAUNA KEA TECHNOLOGIES·03760187910246·
SIRONA CAD/CAM SYSTEM
FDA 510(k)
FDA Class 2
·Dental
NATURALASE DIODE LASER FAMILY NATURALASE MODEL NL980, NATURALASE DIODE LASER FAMILY NATURALASE NL810
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100152111·IN-OVATION® C Base Rx 022 U5-5 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
MUSTANG?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 25, 2025
MUSTANG?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·April 22, 2025
MUSTANG?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LIT·April 28, 2025
MUSTANG?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·August 18, 2025
MUSTANG?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LIT·November 22, 2024
EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·July 30, 2014
MUSTANG?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LIT·August 26, 2025
CONTOUR TEST STRIPS (50)
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·January 12, 2010