Home › Device types › HIB
Speculum, Vaginal, Nonmetal
FDA product code HIB · Class 2 · Obstetrics/Gynecology
321
Registered devices
154
Adverse events
6
Recalls
72
510(k) clearances
Devices with this code
Symmetry Olsen — ASPEN SURGICAL PRODUCTS, INC.MedPride — SHIELD-LINE, LLCSymmetry Olsen — ASPEN SURGICAL PRODUCTS, INC.VAGISPEC KOLPLAST — Kolplast C IVAGISPEC KOLPLAST — Kolplast C IInstraspec — ROBINSON HEALTHCARE LIMITEDSymmetry Olsen — ASPEN SURGICAL PRODUCTS, INC.Welch Allyn, Inc. — WELCH ALLYN, INC.EOS — NORTH EOS INDUSTRIES INC.Instraspec — ROBINSON HEALTHCARE LIMITEDRosa Speculum — MY VILLAGE INNOVATIONS INC.SPECULUX — EVEXAR MEDICAL LIMITEDGalenica — Coopersurgical, Inc.ER-SPEC/OFFICE-SPEC — OBP CORPORATIONOFFICESPEC — OBP CORPORATIONWelch Allyn, Inc. — WELCH ALLYN, INC.PremierPro Vaginal Speculum — PRESTIGE AMERITECH, LTD.Galenica — Coopersurgical, Inc.P&P Medical Surgical LLC — P&P Medical Surgical LLCVAGISPEC KOLPLAST — Kolplast C IEOS — NORTH EOS INDUSTRIES INC.ER-SPEC/OFFICESPEC — OBP CORPORATIONWALLACH — Coopersurgical, Inc.PremierPro Vaginal Speculum — PRESTIGE AMERITECH, LTD.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-13 | OBP Medical Corporation | There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both the |
| 2025-06-11 | CooperSurgical, Inc. | The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine |
| 2025-06-11 | CooperSurgical, Inc. | The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine |
| 2025-06-11 | CooperSurgical, Inc. | The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine |
| 2015-10-02 | Welch Allyn Inc | The firm became aware that the KleenSpec 788 Corded Illuminator has the potential to be incorrectly connected to a commonly available AC power cord instead of t |
| 2015-04-13 | CooperSurgical, Inc. | Small sized specula were incorrectly packaged in printed bags for the medium sized speculum |
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