FDA Device Intelligence
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Speculum, Vaginal, Metal

FDA product code HDF · Class 1 · Obstetrics/Gynecology

3,089
Registered devices
44
Adverse events
3
Recalls
11
510(k) clearances

Devices with this code

Medicon — Medicon eG. Chirurgiemechaniker-GenossenschaftWeisman Graves Speculum Small - Right Side Open — MEDGYN PRODUCTS, INC.Lletz Foerster Forceps — MEDGYN PRODUCTS, INC.BR Surgical, LLC — BR Surgical, LLCELMED — ELMED INCORPORATEDSTINGRAY SURGICAL PRODUCTS — STINGRAY SURGICAL PRODUCTS L.L.C.ELMED — ELMED INCORPORATEDMedicon — Medicon eG. Chirurgiemechaniker-GenossenschaftAvalign — Avalign Technologies, Inc.Millennium — Avalign Technologies, Inc.Sklar® — SKLAR CORPORATIONMarina Medical — MARINA MEDICAL INSTRUMENTS, INC.ELMED — ELMED INCORPORATEDSTINGRAY SURGICAL PRODUCTS — STINGRAY SURGICAL PRODUCTS L.L.C.Novo Surgical Inc. — NOVO SURGICAL, INC.Symmetry Surgical® — ASPEN SURGICAL PRODUCTS, INC.Millennium — Avalign Technologies, Inc.Novo Surgical Inc. — NOVO SURGICAL, INC.ELMED INCORPORATED — ELMED INCORPORATEDSymmetry Surgical® — ASPEN SURGICAL PRODUCTS, INC.BR Surgical, LLC — BR Surgical, LLCMillennium — Avalign Technologies, Inc.ELMED — ELMED INCORPORATEDGimmi — Gimmi GmbH

Recent recalls

DateFirmReason
2024-12-03Sklar InstrumentsReports of various packaging issues that may result in a breach of the sterile barrier.
2023-03-16Carefusion 2200 IncA portion of the two products were incorrectly marked (etched) and packaged resulting in a product mismatch. The labels and laser etchings were switched on the
2019-07-01Centurion Medical Products CorporationPotential for sterile packaging to be compromised

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.