140 results · 21ms · Sources: EU EUDAMED, 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