15 results · 19ms · Sources: EU EUDAMED, US FDA

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ANTI-CARDIOLIPIN ANTIBODY (IGM-ACA) TEST

FDA 510(k)
FDA Class 2 ·Immunology

COOK HOLMIUM LASER FIBER

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

EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System

FDA 510(k)
FDA Class 2 ·Radiology

ENCOR BREAST BIOPSY PROBE

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code KNW·April 3, 2014

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·January 29, 2013

ENSEAL TRIO 3MM CURVE TIP 35 C

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GEI·December 21, 2010

COOK® MULTI-USE HOLMIUM LASER FIBER

FDA Adverse Event
Malfunction ·COOK INC·Product code GEX·May 10, 2019

COOK SINGLE-USE HOLMIUM LASER FIBER

FDA Adverse Event
Malfunction ·COOK INC·Product code GEX·February 21, 2020

COOK® SINGLE-USE HOLMIUM LASER FIBER

FDA Adverse Event
Malfunction ·COOK INC·Product code GEX·August 19, 2019

COOK® SINGLE-USE HOLMIUM LASER FIBER

FDA Adverse Event
Malfunction ·COOK INC·Product code GEX·October 15, 2019

COOK® SINGLE-USE HOLMIUM LASER FIBER

FDA Adverse Event
Malfunction ·COOK INC·Product code GEX·December 10, 2019

COOK® SINGLE-USE HOLMIUM LASER FIBER

FDA Adverse Event
Injury ·COOK INC·Product code GEX·November 4, 2022

COOK SINGLE-USE HOLMIUM LASER FIBER

FDA Adverse Event
Malfunction ·COOK INC·Product code GEX·March 3, 2020

COOK SINGLE-USE HOLMIUM LASER FIBER

FDA Adverse Event
Malfunction ·COOK INC·Product code GEX·February 13, 2020

ev3 Pipeline Flex Embolization Device. For neurological endovascular use.

FDA Enforcement
Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020