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Laryngostroboscope
FDA product code EQL · Class 1 · Ear, Nose, Throat
119
Registered devices
149
Adverse events
2
Recalls
8
510(k) clearances
Devices with this code
JEDMED — JEDMED INSTRUMENT COMPANYJEDMED — JEDMED INSTRUMENT COMPANYN/A — PENTAX OF AMERICA, INC.JEDMED — JEDMED INSTRUMENT COMPANYOptomic — OPTOMIC ESPAÑA SAJEDMED — JEDMED INSTRUMENT COMPANYn.a. — Karl Storz GmbH & Co. KGJEDMED — JEDMED INSTRUMENT COMPANYPULSAR — Karl Storz GmbH & Co. KGJEDMED — JEDMED INSTRUMENT COMPANYJEDMED — JEDMED INSTRUMENT COMPANYN/A — PENTAX OF AMERICA, INC.MACHIDA — MACHIDA ENDOSCOPE CO.,LTD.LARYNGOSTROBOSCOPE — PENTAX OF AMERICA, INC.JEDMED — JEDMED INSTRUMENT COMPANYPENTAX — HOYA CORPORATIONJEDMED — JEDMED INSTRUMENT COMPANYOptomic — OPTOMIC ESPAÑA SAJEDMED — JEDMED INSTRUMENT COMPANYN/A — PENTAX OF AMERICA, INC.N/A — PENTAX OF AMERICA, INC.JEDMED — JEDMED INSTRUMENT COMPANYn.a. — Karl Storz GmbH & Co. KGLARYNGOSTROBOSCOPE — Ecleris
Recent 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 |
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