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OPHTHALMIC EXAMINATION LAMP
Heine Optotechnik GmbH & Co. KG · Model 3,5 V · UDI-DI 04053755120109
10
510(k) clearances
7
Adverse events
3
Recalls
12
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-16 | Vortex Surgical Inc. | XXX |
| 2007-11-09 | Chiu Technical Corp | Device was marketed without a 510(k). |
| 2003-11-10 | Bausch & Lomb Inc | The CX9625 Light Pipe connector may overheat; this condition could result in the plastic connector that plugs into the Millennium Microsurgical System to malfunction. |
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Get your free API keyRead the docsData 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.