12 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Electric Scooter (M2085, S2091)
FDA 510(k)
FDA Class 2
·Physical Medicine
Delta®
FDA UDI
MEDTRONIC PS MEDICAL, INC.·00643169483460·ASSY 24027-2 DELTA SHUNT SNAP SML 2
SWIFT-LOCK ANCHOR
FDA 510(k)
FDA Class 2
·Neurology
SYNTHES (USA) CRANIOFACIAL PLATES
FDA 510(k)
FDA Class 2
·Dental
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·July 28, 2022
IMP TM 4.7MM MTX FULL, 10
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·August 11, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·June 15, 2023
COLLEAGUE 3 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 24, 2008
QUICKFLEX XL LV LEAD
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·September 9, 2011
840 VENTILATOR
FDA Adverse Event
Injury
·COVIDIEN FORMERLY NELLCOR PURITAN BENNETT IRELAND·Product code CBK·July 18, 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 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