12 results
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21ms
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Sources: EU EUDAMED, US FDA
InSee
FDA 510(k)
FDA Class 2
·Anesthesiology
Oticon
FDA UDI
Sbo Hearing A/S·05714464055746·OTICON MORE 1 MINIRITE R C093 DEMO
LCP
FDA UDI
Synthes GmbH·10886982165992·3.5MM LCP T-PLATE 4H HEAD/ 5H SHAFT/67MM-RIGHT ...
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780160069·Integra® Miltex® DEBAKEY Patent Ductus and Peri...
ADVANTAGE
FDA 510(k)
FDA Class 2
·Anesthesiology
THINSET 1.8 ML RESERVOIR, MODEL 326A; THINSET 3.0 ML RESERVOIR, MODEL 332A
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 29, 2025
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·October 27, 2023
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75 CM NON US
FDA Adverse Event
Injury
·COSTA RICA·Product code LTI·November 19, 2008
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·August 17, 2011
LD304 MATERNITY BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code HDD·July 22, 2013
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