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ELMED
ELMED INCORPORATED · Model 40-2221 · UDI-DI 00842180151901
CCW
Prescription
10
510(k) clearances
7,485
Adverse events (68 deaths)
53
Recalls
318
Facilities
Description
Low-Profile Dedo-Style Laser Laryngoscope, Adult is supplied with a single light carrier, flush with the handle, which accommodates a slim and lightweight blue Pilling fiberoptic cable (sold separately). Size Adult. Length 178mm, Min I.D. 10.7mm, Nominal Proximal Dims 19.0mm x 19.0mm, Max O.D. 25.5mm,
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-07-11 | Flexicare Medical (Dongguan) Ltd. | Laryngoscope handles may not illuminate as intended. |
| 2025-07-11 | Flexicare Medical (Dongguan) Ltd. | Laryngoscope handles may not illuminate as intended. |
| 2025-07-11 | Flexicare Medical (Dongguan) Ltd. | Laryngoscope handles may not illuminate as intended. |
| 2025-07-11 | Flexicare Medical (Dongguan) Ltd. | Laryngoscope handles may not illuminate as intended. |
| 2025-07-11 | Flexicare Medical (Dongguan) Ltd. | Laryngoscope handles may not illuminate as intended. |
| 2025-07-11 | Flexicare Medical (Dongguan) Ltd. | Laryngoscope handles may not illuminate as intended. |
| 2025-06-17 | Intersurgical Inc | Potential for faulty devices as a result of depleted batteries. |
| 2024-07-09 | Covidien | Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion. |
| 2024-07-09 | Covidien | IFU update to address device's battery handling information. |
| 2024-07-09 | Covidien | Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion. |
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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.