11 results
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22ms
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Sources: EU EUDAMED, US FDA
TECHFIT Patient-Specific Cranial System
FDA 510(k)
FDA Class 2
·Neurology
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011250297030·ceraMotion® Paste 3D transpa / dental ceramic m...
TANDEM MOBI INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·June 7, 2025
PlasmaBlade UPPP and Suction Coagulator
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SOMATOM EMOTION 16
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 8, 2025
HEARTSTART SLA BATTERY
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code DQA·November 6, 2014
GYNECARE TVT SECUR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code PAH·July 26, 2013
CARPENTIER-EDWARDS PERIMOUNT® MAGNA MITRAL PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·November 25, 2015
BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·July 21, 2020
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