12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Cellinew
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Oticon
FDA UDI
Sbo Hearing A/S·05714464055173·OTICON PLAY PX 2 MINIRITE R C093
SYNGO.MR NEUROLOGY, SYNGO.MMR GENERAL
FDA 510(k)
FDA Class 2
·Radiology
DOVER ROB-NEL CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TERA HARZ CLEAR
FDA Adverse Event
Injury
·GRAPHY INC.·Product code NXC·June 16, 2025
TERA HARZ CLEAR
FDA Adverse Event
Injury
·GRAPHY INC.·Product code NXC·June 16, 2025
TERA HARZ CLEAR
FDA Adverse Event
Injury
·GRAPHY INC.·Product code NXC·June 16, 2025
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·September 9, 2011
CURVED CUTTER STAPLER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·November 10, 2014
INRATIO2
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·July 17, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 29, 2014