19 results · 40ms · Sources: EU EUDAMED, US FDA

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FLEXMEDICS NITINOL ARCH WIRE

FDA 510(k)
FDA Class 1 ·Dental

NEUROMOD COMPLEMENT #7724 DUAL CHANNEL

FDA 510(k)
FDA Class 2 ·Neurology

RESONANCE METALLIC URETERAL STENT

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

RESONANCE STENT SET

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FAD·December 13, 2018

RESONANCE STENT SET

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FAD·October 31, 2018

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·June 10, 2014

ENDOTAK RELIANCE

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVY·October 11, 2010

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·December 10, 2012

RESONANCE STENT SET

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FAD·October 6, 2023

RESONANCE STENT SET

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FAD·July 25, 2018

RESONANCE STENT SET

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FAD·May 29, 2015

Connecting Tube - Female to Male Luer Lock, HPCT8.8-120-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.

FDA Enforcement
Class II ·Terminated·Cook Inc.·May 16, 2018

RESONANCE STENT SET

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FAD·October 11, 2018

RESONANCE STENT SET

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FAD·November 22, 2018

RESONANCE STENT SET

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FAD·September 27, 2023

RESONANCE STENT SET

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FAD·August 13, 2018

RESONANCE STENT SET

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FAD·September 12, 2018

RESONANCE STENT SET

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FAD·August 16, 2018

RESONANCE STENT SET

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FAD·January 22, 2019