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Speculum, Ent
FDA product code EPY · Class 1 · General, Plastic Surgery
3,796
Registered devices
10
Adverse events
2
Recalls
12
510(k) clearances
Devices with this code
RZ Medizintechnik GmbH — RZ-Medizintechnik GmbHNovo Surgical Inc. — NOVO SURGICAL, INC.AESCULAP — Aesculap AGRZ Medizintechnik GmbH — RZ-Medizintechnik GmbHAESCULAP — Aesculap AGBR Surgical, LLC — BR Surgical, LLCFENTEX — FENTEX medical GmbHMSI Precision Specialty Instruments — Med Saver, Inc.HNM MEDICAL — HNM STAINLESS, LLC.GEN2 — SURGIX MEDICAL LLCMedicon — Medicon eG. Chirurgiemechaniker-GenossenschaftMarina Medical — MARINA MEDICAL INSTRUMENTS, INC.Ear Specula - 3mm Non-Sterile — ADEPT MEDICAL LIMITEDSPECULUM — KLS-Martin L.P.mytaMed — Mytamed, Inc.Bausch + Lomb — Bausch & Lomb IncorporatedSymmetry Hartmann — ASPEN SURGICAL PRODUCTS, INC.HARTMANN-HALLE NASAL SPECULUM — SONTEC INSTRUMENTS, INC.BR Surgical, LLC — BR Surgical, LLCNovo Surgical Inc. — NOVO SURGICAL, INC.Millennium — Avalign Technologies, Inc.Ambler Surgical — AMBLER SURGICAL CORP.Marina Medical — MARINA MEDICAL INSTRUMENTS, INC.BEAR — Bear-Ent, LLC
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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