ELMED

ELMED INCORPORATED · Model 9700 · UDI-DI 00842180183308

HPP Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

C3, 3WATT PORTABLE LED HEADLIGHT SYSTEM MOUNTED ON COMFORT FULLY ADJUSTABLE HEADBAND. INCLUDING-HEADLIGHT, RECHARGEABLE LITHIUM BATTERY PACK W/BUILT IN BELT CLIP, BATTERY CHARGER AND CARRYING CASE

Recalls

Date	Firm	Reason
2014-06-11	Integra LifeSciences Corp.	LED battery chargers may prematurely fail and will not charge the LED battery as intended

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.