Home › Device types › LNM
Agent, Bulking, Injectable For Gastro-Urology Use
FDA product code LNM · Class 3 · Unknown
13
Registered devices
1,158
Adverse events
3
Recalls
0
510(k) clearances
Devices with this code
Durasphere ® EXP — Carbon Medical Technologies, Inc.Solesta — PALETTE LIFE SCIENCES, INC.Durasphere ® EXP — Carbon Medical Technologies, Inc.Coaptite — MERZ NORTH AMERICA, INC.Macroplastique Implants — Uroplasty, Inc.Coaptite — MERZ NORTH AMERICA, INC.Deflux® — SALIX PHARMACEUTICALS, LTD.Bulkamid — Contura International A/SDeflux — PALETTE LIFE SCIENCES, INC.Bulkamid — AXONICS MODULATION TECHNOLOGIES, INC.Deflux Metal Needle — PALETTE LIFE SCIENCES, INC.Solesta® — SALIX PHARMACEUTICALS, LTD.Bulkamid — AXONICS MODULATION TECHNOLOGIES, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-06-03 | Axonics Modulation Technologies, Inc. | Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized |
| 2020-09-30 | Merz North America, Inc. | The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study. |
| 2005-09-23 | Boston Scientific Corporation | Incorrect implantation may cause serious health complications |
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