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

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Dermal Cooling System

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

MONARCH SPINAL SYSTEMS

FDA 510(k)
FDA Class 2 ·Orthopedic

SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR

FDA 510(k)
FDA Class 2 ·Orthopedic

DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 6, 2025

10.0 MM FLIP CUTTER II

FDA Adverse Event
Injury ·ARTHREX INC.·Product code MDM·December 1, 2017

10.0 MM FLIP CUTTER II

FDA Adverse Event
Injury ·ARTHREX INC.·Product code MDM·December 1, 2017

VIDEO MEDIASTINOSCOPE

FDA Adverse Event
Injury ·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021

VIDEO MEDIASTINOSCOPE

FDA Adverse Event
Injury ·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021

VIDEO MEDIASTINOSCOPE

FDA Adverse Event
Injury ·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021

SYNCHROMED EL

FDA Adverse Event
Injury ·RICE CREEK MANUFACTURING·Product code LKK·October 27, 2008

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011

LYNX SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 9, 2013

VIDEO MEDIASTINOSCOPE

FDA Adverse Event
Injury ·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021

CARTO® 3 SYSTEM

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·May 22, 2024

CARTO® 3 SYSTEM

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·December 19, 2023

11.0 MM FLIP CUTTER II

FDA Adverse Event
Injury ·ARTHREX INC.·Product code MDM·December 1, 2017

CARTO 3 SYSTEM

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·June 14, 2024

CARTO® 3 SYSTEM

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·June 3, 2024

CARTO 3 SYSTEM

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·November 27, 2023

CARTO® 3 SYSTEM

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·December 26, 2023