27 results · 23ms · Sources: EU EUDAMED, US FDA

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IPL Therapy Machine

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

MEDISLIM

FDA Adverse Event
Injury ·MEDICREATIONS, LLC·Product code GEX·April 27, 2020

QUASAR CALYPSO

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04

FDA 510(k)
FDA Class 2 ·Anesthesiology

CONTOUR® PLUS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·September 10, 2025

CONTOUR® XT

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 23, 2026

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

FINELINE II

FDA Adverse Event
Malfunction ·CPI - DEL CARIBE·Product code NVN·July 13, 2011

STARCLOSE VASCULAR CLOSURE SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·September 15, 2008

CONTOUR® PLUS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 1, 2026

CONTOUR® XT

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 15, 2025

CONTOUR® PLUS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 31, 2025

CONTOUR® NEXT

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 12, 2026

CONTOUR® PLUS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·September 11, 2025

UNIVERSA FIRM URETERAL STENT SET

FDA Adverse Event
Malfunction ·COOK INC·Product code FAD·June 25, 2019

UNIVERSA FIRM URETERAL STENT SET

FDA Adverse Event
Malfunction ·COOK INC·Product code FAD·June 25, 2019

UNIVERSA FIRM URETERAL STENT SET

FDA Adverse Event
Malfunction ·COOK INC·Product code FAD·June 26, 2019

UNIVERSA FIRM URETERAL STENT SET

FDA Adverse Event
Malfunction ·COOK INC·Product code FAD·December 31, 2019

UNIVERSA FIRM URETERAL STENT SET

FDA Adverse Event
Malfunction ·COOK INC·Product code FAD·December 31, 2019

CONTOUR® PLUS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·October 8, 2025