Home › Device types › MRD
Mammary Sizer
FDA product code MRD · Class U · Unknown
1,318
Registered devices
287
Adverse events
4
Recalls
13
510(k) clearances
Devices with this code
Round Breast Implant Sizer, High Projection — SPECIALTY SURGICAL PRODUCTS INCNATRELLE Resterilizable Breast Implant Sizers — Allergan, Inc.Motiva Implant Matrix — Establishment Labs S.A.NATRELLE Resterilizable Breast Implant Sizers — Allergan, Inc.Motiva Implant Matrix — Establishment Labs S.A.Natrelle Inspira ST Resterilizable Sizers — Allergan, Inc.Motiva Implant Matrix — Establishment Labs S.A.Natrelle 410 Resterilizable Sizers — Allergan, Inc.Natrelle INSPIRA Resterilizable Sizers — Allergan, Inc.MENTOR Round Moderate Plus Profile Single Use Saline Breast Implant Sizer — MENTOR TEXAS L.P.MENTOR MemoryGel BOOST Resterilizable Gel Sizer — MENTOR TEXAS L.P.MENTOR Round Moderate Profile Single Use Saline Breast Implant Sizer — MENTOR TEXAS L.P.Natrelle 410 Resterilizable Sizers — Allergan, Inc.Motiva Implant Matrix — Establishment Labs S.A.MENTOR Round Moderate Plus Profile Single Use Saline Breast Implant Sizer — MENTOR TEXAS L.P.MENTOR MemoryGel Xtra Resterilizable Gel Sizer — MENTOR TEXAS L.P.NATRELLE Resterilizable Breast Implant Sizers — Allergan, Inc.Motiva Implant Matrix — Establishment Labs S.A.Single Use Sterile Saline Breast Implant Sizer for Natrelle Style 68/168 MP — SPECIALTY SURGICAL PRODUCTS INCNATRELLE INSPIRA Single Use Sizers — Allergan, Inc.NATRELLE INSPIRA Single Use Sizers — Allergan, Inc.SIENTRA Silicone Gel Breast Implant Sizer — Sientra, Inc.SIENTRA Silicone Gel Breast Implant Sizer — Sientra, Inc.MENTOR MemoryShape LM Plus Resterilizable Gel Sizer — MENTOR TEXAS L.P.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-11-06 | Allergan PLC | The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separa |
| 2015-06-08 | Allergan Inc | Allergan is recalling the NATRELLE 410cc Re-Sterilizable Breast Implant Sizer because the expired product was shipped to the user level. |
| 2014-12-11 | Mentor Texas, LP. | The IFU provided in the affected units of the MENTOR MemoryGel Resterilizable Sizer is incorrect. Those units include the IFU for the MENTOR MemoryShape Rester |
| 2014-07-02 | Mentor Texas, LP. | The device labeling is stamped with 330cc and the device is actually 380cc device. |
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