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Laryngostroboscope
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Model 8000-S · UDI-DI 00848657070218
EQL
Prescription
8
510(k) clearances
151
Adverse events
2
Recalls
34
Facilities
Description
Laryngostroboscopes employ the oscillating light of a high-power fluorescent light source that is monitored by the laryngeal vibrations through a throat microphone.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-12-12 | Pentax of America Inc | Pentax is initiating a Field Correction to revise the Instructions for Use of the Rigid Laryngostroboscopes Model 9106 and 9108. |
| 2016-04-06 | Pentax Medical Company | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel. |
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