Home › Device types › HHM
Sound, Uterine
FDA product code HHM · Class 1 · Obstetrics/Gynecology
264
Registered devices
92
Adverse events
4
Recalls
10
510(k) clearances
Devices with this code
Millennium — Avalign Technologies, Inc.Millennium — Avalign Technologies, Inc.Millennium — Avalign Technologies, Inc.Millennium — Avalign Technologies, Inc.Millennium — Avalign Technologies, Inc.GEN2 — SURGIX MEDICAL LLCGimmi — Gimmi GmbHMillennium — Avalign Technologies, Inc.Integra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHank Cervical Dilator Set — Coopersurgical, Inc.Symmetry Sims — ASPEN SURGICAL PRODUCTS, INC.HNM Medical — HNM STAINLESS, LLC.Cervical Dilator Set — Coopersurgical, Inc.Medicon — Medicon eG. Chirurgiemechaniker-GenossenschaftMillennium — Avalign Technologies, Inc.Millennium — Avalign Technologies, Inc.Gimmi — Gimmi GmbHMillennium — Avalign Technologies, Inc.Ambler Value Line — AMBLER SURGICAL CORP.Sims Uterine Sound — DTR MEDICAL LIMITEDMillennium — Avalign Technologies, Inc.Millennium — Avalign Technologies, Inc.Millennium — Avalign Technologies, Inc.Millennium — Avalign Technologies, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-07-31 | CooperSurgical, Inc. | During the manufacturing process the devices were laser-marked with the incorrect part number. |
| 2024-07-31 | CooperSurgical, Inc. | During the manufacturing process the devices were laser-marked with the incorrect part number. |
| 2019-12-11 | Centurion Medical Products Corporation | Incomplete seals on the sterile package may compromise the sterility |
| 2016-10-28 | Hologic, Inc | Breach in sterile barrier compromising product sterility |
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