8 results
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21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Erchonia GVL
FDA 510(k)
FDA Class 2
·Physical Medicine
WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PARCOMPLAST COMPENSATING FILTER FOR RADIATION THERAPY
FDA 510(k)
FDA Class 2
·Radiology
HEARTMATE XVE LVAS
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·November 6, 2008
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·August 24, 2011
HEARTSTART MRX - EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 3, 2013
CODMAN Disposable Perforator 11mm. Cranial Perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·November 12, 2025
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025