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Speculum, Ent
FDA product code EPY · Class 1 · General, Plastic Surgery
3,990
Registered devices
10
Adverse events
2
Recalls
12
510(k) clearances
Devices with this code
MSI Precision Specialty Instruments — Med Saver, Inc.Farrior ear speculum — Spiggle & Theis Medizintechnik GmbHGimmi — Gimmi GmbHSinus speculum for adults — Spiggle & Theis Medizintechnik GmbHMillennium — Avalign Technologies, Inc.Sklar® — SKLAR CORPORATIONSnowden-Pencer — STERIS CORPORATIONSurtex — SURTEX INSTRUMENTS LTD.Millennium — Avalign Technologies, Inc.FENTEX — FENTEX medical GmbHRZ Medizintechnik GmbH — RZ-Medizintechnik GmbHNovo Surgical — NOVO SURGICAL, INC.HNM Medical — HNM STAINLESS, LLC.RZ Medizintechnik GmbH — RZ-Medizintechnik GmbHIntegra® Jarit® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONIntegra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONCOTTLE SEPTUM SPECULUM — SONTEC INSTRUMENTS, INC.JEDMED — JEDMED INSTRUMENT COMPANYIntegra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONBR Surgical, LLC — BR Surgical, LLCCottle Speculum, 110mm flared tip — MIZUHO AMERICA, INC.Avalign — Avalign Technologies, Inc.Integra® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONAESCULAP — AESCULAP, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| 2024-02-23 | MEDLINE INDUSTRIES, LP - Northfield | Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
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