24 results · 25ms · Sources: EU EUDAMED, US FDA

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OEC Elite

FDA 510(k)
FDA Class 2 ·Radiology

POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

REMEL SPECTRA VRE

FDA 510(k)
FDA Class 2 ·Microbiology

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 4, 2024

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 22, 2025

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·October 22, 2014

NC SPRINTER RX BALLOON DILATATION CATHETER

FDA Adverse Event
Malfunction ·MEDTRONIC IRELAND·Product code LOX·July 20, 2011

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 27, 2013

POUNCE VENOUS THROMBECTOMY SYSTEM

FDA Adverse Event
Injury ·SURMODICS INC·Product code QEW·May 16, 2024

FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

FDA Adverse Event
Injury ·COOK INC·Product code DYB·October 29, 2025

FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

FDA Adverse Event
Injury ·COOK INC·Product code DYB·October 29, 2025

FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·September 29, 2020

DYB INTRODUCER, CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code DYB·November 12, 2025

FLEXOR SHUTTLE SELECT GUIDING SHEATH

FDA Adverse Event
Injury ·COOK INC·Product code DYB·October 29, 2025

FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·January 12, 2018

FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·April 19, 2021

UNKNOWN

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·September 15, 2020

FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·January 16, 2020

FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·August 15, 2019

FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·December 4, 2019