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Surgical laryngoscope, spreadable

Spiggle & Theis Medizintechnik GmbH · Model 50-202-05 · UDI-DI 04250381858356

CCW Prescription
10
510(k) clearances
7,576
Adverse events (70 deaths)
53
Recalls
317
Facilities

Description

size 5, for men, 172 mm long ID 16 mm, OD 29x19 mm

Recalls

DateFirmReason
2025-07-11Flexicare Medical (Dongguan) Ltd.Laryngoscope handles may not illuminate as intended.
2025-07-11Flexicare Medical (Dongguan) Ltd.Laryngoscope handles may not illuminate as intended.
2025-07-11Flexicare Medical (Dongguan) Ltd.Laryngoscope handles may not illuminate as intended.
2025-07-11Flexicare Medical (Dongguan) Ltd.Laryngoscope handles may not illuminate as intended.
2025-07-11Flexicare Medical (Dongguan) Ltd.Laryngoscope handles may not illuminate as intended.
2025-07-11Flexicare Medical (Dongguan) Ltd.Laryngoscope handles may not illuminate as intended.
2025-06-17Intersurgical IncPotential for faulty devices as a result of depleted batteries.
2024-07-09CovidienIFU update to address device's battery handling information.
2024-07-09CovidienBattery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion.
2024-07-09CovidienBattery 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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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.