9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Facial Toning device (UIC-189); Facial Toning device (UIC-589)
FDA 510(k)
FDA Class 2
·Neurology
Bernafon
FDA UDI
Sbo Hearing A/S·05714464042975·BERNAFON, CHARGER MNB T R DEMO
SLIT LAMP SL-D701
FDA 510(k)
FDA Class 2
·Ophthalmic
CARRARA PRESS SYSTEM
FDA 510(k)
FDA Class 2
·Dental
NC TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·November 6, 2014
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 2, 2011
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·July 18, 2013
Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967
FDA Enforcement
Class II
·Ongoing·Preat Corp·March 27, 2024
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025