Home › Device types › HIB
Speculum, Vaginal, Nonmetal
FDA product code HIB · Class 2 · Obstetrics/Gynecology
312
Registered devices
152
Adverse events
6
Recalls
72
510(k) clearances
Devices with this code
ClearSpec — Clearspec LLCVAGISPEC KOLPLAST — Kolplast C IBlueline — Transparent Supply Solutions Ltd.P&P Medical Surgical LLC — P&P Medical Surgical LLCCenturion — CENTURION MEDICAL PRODUCTS CORPORATIONWelch Allyn, Inc. — WELCH ALLYN, INC.EOS — NORTH EOS INDUSTRIES INC.Blueline — Transparent Supply Solutions Ltd.Welch Allyn, Inc. — WELCH ALLYN, INC.Gynescope single use vaginal speculume size small 60 units — ILLUMIGYN LTDSPECULUX — EVEXAR MEDICAL LIMITEDWelch Allyn, Inc. — WELCH ALLYN, INC.Symmetry Olsen — ASPEN SURGICAL PRODUCTS, INC.VAGISPEC KOLPLAST — Kolplast C IDeRoyal — DEROYAL INDUSTRIES, INC.PremierPro Vaginal Speculum — PRESTIGE AMERITECH, LTD.MONARCH DISPOSO-SPEC — MONARCH MOLDING, INC.SURGYCO — Surgyco LLCPremierPro — PRESTIGE AMERITECH, LTD.Bioseal Inc. — BIOSEALVAGISPEC KOLPLAST — Kolplast C IClearSpec — Clearspec LLCUltraspec — ROBINSON HEALTHCARE LIMITEDDealmed — DEALMED MEDICAL SUPPLIES LLC
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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