19 results
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40ms
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Sources: EU EUDAMED, US FDA
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