4 results
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42ms
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Sources: EU EUDAMED, US FDA
Class IV New Era medical laser device
FDA Recall
Open, Classified
·Inova Lasers LLC·Product code GEX·January 29, 2020
Class IV New Era medical laser device
FDA Enforcement
Class II
·Ongoing·Inova Lasers LLC·November 25, 2020
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices
Kingsmead Service B.V.
Authorized representative
🇳🇱 Netherlands·243 Manufacturers·2698 Devices