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Speculum, Vaginal, Metal
FDA product code HDF · Class 1 · Obstetrics/Gynecology
3,206
Registered devices
44
Adverse events
3
Recalls
11
510(k) clearances
Devices with this code
Medicon — Medicon eG. Chirurgiemechaniker-GenossenschaftMarina Medical — MARINA MEDICAL INSTRUMENTS, INC.ELMED INCORPORATED — ELMED INCORPORATEDMedicon — Medicon eG. Chirurgiemechaniker-GenossenschaftELMED INCORPORATED — ELMED INCORPORATEDMarina Medical — MARINA MEDICAL INSTRUMENTS, INC.RZ Medizintechnik GmbH — RZ-Medizintechnik GmbHELMED — ELMED INCORPORATEDELMED INCORPORATED — ELMED INCORPORATEDTrinity Sterile, Inc. — Trinity Sterile, Inc.Sklar® — SKLAR CORPORATIONGynex — GYNEX CORPORATIONIntrace USA — PILOTIS TECH LLCIntegra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONMillennium — Avalign Technologies, Inc.ELMED INCORPORATED — ELMED INCORPORATEDHayden Medical — Hayden Medical, Inc.Graves Speculum X Large — MedGyn Products, Inc.Symmetry Breisky — ASPEN SURGICAL PRODUCTS, INC.Hayden Medical — Hayden Medical, Inc.Millennium — Avalign Technologies, Inc.ELMED INCORPORATED — ELMED INCORPORATEDHayden Medical — Hayden Medical, Inc.Gynex — GYNEX CORPORATION
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. |
| 2023-03-16 | Carefusion 2200 Inc | A 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 |
| 2019-07-01 | Centurion Medical Products Corporation | Potential for sterile packaging to be compromised |
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