17 results · 22ms · Sources: EU EUDAMED, US FDA

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SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

DELTA

FDA UDI
Stryker Leibinger GmbH & Co. KG·07613327177510·DELTA 1.7MM 2X21 HYBRID CNTRSINKS 0.5MM

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450267448·

STAT PROFILE PHOX PLUS L ANALYZER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

VECTORSURGE 5, MODEL VS-500

FDA 510(k)
FDA Class 2 ·Physical Medicine

CONTOUR®

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·June 19, 2025

CONTOUR TEST STRIPS

FDA Adverse Event
Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·May 31, 2012

BREEZE2

FDA Adverse Event
Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·February 18, 2015

CONTOUR NEXT

FDA Adverse Event
Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·June 13, 2014

CONTOUR

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 5, 2019

CONTOUR® TS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·August 21, 2025

FORTIFY DR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC. CRMD·Product code LWS·January 13, 2014

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 3, 2013

CONSULTA CRT-D

FDA Adverse Event
Death ·MEDTRONIC MED REL, INC.·Product code NIK·May 18, 2011

CONTOUR® TS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·August 21, 2025

CONTOUR® TS

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

CONTOUR®

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 13, 2025