11 results
·
22ms
·
Sources: EU EUDAMED, US FDA
gi2000 Electrosurgical Generator
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Phoenix XL Dialysate Meter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MONDEAL CONTOUR HO SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·September 13, 2011
1320894-2008-00127
FDA Adverse Event
Malfunction
·Product code MLN·August 29, 2008
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 26, 2013
11-VI Incorporated Laser diode component Non-certified laser diode component used in laser sights for firearms
FDA Enforcement
Class II
·Terminated·Ii - Vi Incorporated·June 13, 2018
Crimson Trace Corporation laser sights. The Finished Products are laser sighting systems for firearms, used for personal defense and target acquisition.
FDA Enforcement
Class II
·Terminated·Crimson Trace Corporation·May 2, 2018
Crimson Trace Corporation laser sights. The Finished Products are laser sighting systems for firearms, used for personal defense and target acquisition.
FDA Recall
Terminated
·Crimson Trace Corporation·Product code REU·October 10, 2017
11-VI Incorporated Laser diode component Non-certified laser diode component used in laser sights for firearms
FDA Recall
Terminated
·Ii Vi Incorporated·Product code N/A·December 13, 2017
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013