37 results · 21ms · Sources: EU EUDAMED, US FDA

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EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT

FDA 510(k)
FDA Class 2 ·Cardiovascular

IN-OVATION® C

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151801·IN-OVATION® C EURO 018 U5-5 CS HK

Ovation S

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K410151101·Ovation ® S BASE / .018 5x5 CS HK

IN-OVATION® C

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151101·IN-OVATION® C Base Rx 018 UP5-5 CHK

IN-OVATION® C

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151111·IN-OVATION® C Base Rx 018 U5-5 CS-BC HK

IN-OVATION® C

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151811·IN-OVATION® C EURO 018 U5-5 CS-BC HK

IN-OVATION® C

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151001·IN-OVATION® C Base Rx 018 U5-5

Ovation S

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K410151801·Ovation ® S EURO / .018 5x5 CS -HK

MYSTIQUE® MB

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K110151101·MYSTIQUE® MB RT RX 018 U 5-5 CS HK

Ovation S

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K410151811·Ovation ® S EURO / .018 5x5 CS-BC HK

Ovation S

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K410151111·Ovation ® S BASE / .018 5x5 CS-BC HK

IN-OVATION® C

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151611·IN-OVATION® C Roncone 018 U5-5 CS BC HK

OASIS BILIARY STENT INTRODUCTION SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM)

FDA 510(k)
FDA Class 2 ·Orthopedic

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·February 24, 2023

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·July 7, 2022

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·March 21, 2023

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·May 11, 2023

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·June 2, 2023

OT VERIO2 METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE GMBH·Product code NBW·July 24, 2019