LNMFDA Class 3
Agent, Bulking, Injectable For Gastro-Urology Use
Device family · Unknown
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
277
Manufacturers
8
Flagged signals
17
Adverse-event reports
725
Code matrix
| FDA product code | LNM |
| Device class | Class 3 |
| Regulation | — |
| GMDN | — (crosswalk pending) |
| Implantable | No |
| Life-sustaining | No |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Other | 2009 | 13 | 576.5 | 6,912 |
| Other | 2010 | 13 | 411.8 | 4,930 |
| Other | 2009 | 8 | 253.4 | 1,769 |
| Other | 2011 | 11 | 182.9 | 1,815 |
| Other | 2010 | 13 | 176.5 | 2,099 |
| Other | 2012 | 18 | 166.3 | 2,798 |
| Other | 2010 | 10 | 166.3 | 1,484 |
| Other | 2009 | 12 | 162.9 | 1,774 |
| Other | 2011 | 9 | 122.2 | 965 |
| Other | 2012 | 7 | 116.4 | 690 |
| Other | 2011 | 7 | 95.0 | 561 |
| Other | 2012 | 10 | 92.4 | 816 |
| Other | 2009 | 5 | 83.1 | 328 |
| Other | 2011 | 6 | 55.4 | 269 |
| Other | 2010 | 3 | 40.7 | 80 |
| Other | 2013 | 4 | 36.9 | 106 |
| Other | 2013 | 3 | 27.7 | 53 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 3 family · 725 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Palette Life Sciences | 128 | 2024 | — |
| MERZ NORTH AMERICA, INC. | 75 | 2026 | — |
| BOSTON SCIENTIFIC CORPORATION | 21 | 2026 | 0.14 |
| Carbon Medical Technologies, Inc. | 21 | 2026 | — |
| Uroplasty, LLC | 12 | 2023 | — |
| Allergan, Inc. | 10 | 2009 | — |
| Boston Scientific Corp | 5 | 2005 | — |
| C.R. Bard, Inc. | 5 | 2007 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
COAPTITE® Injectable Implant · Merz North America, Inc.PMA · 2026-03-18
Durasphere Injectable Bulking Agent · Carbon Medical Technologies, Inc.PMA · 2026-03-13
COAPTITE · Merz North America, Inc.PMA · 2026-01-13
Bulkamid Urethral Bulking System · Boston Scientific CorporationPMA · 2026-01-02
COAPTITE · Merz North America, Inc.PMA · 2025-12-12
COAPTITE Injectable Implant · Merz North America, Inc.PMA · 2025-08-27
COAPTITE® · Merz North America, Inc.PMA · 2025-06-16
Bulkamid Urethral Bulking System · Boston Scientific CorporationPMA · 2025-05-22
Bulkamid Urethral Bulking System · Boston Scientific CorporationPMA · 2025-05-20
Coaptite · Merz North America, Inc.PMA · 2025-04-01
Bulkamid Urethral Bulking System · Boston Scientific CorporationPMA · 2025-03-05
Bulkamid Urethral Bulking System · Boston Scientific CorporationPMA · 2024-11-19
Bulkamid Urethral Bulking System · Boston Scientific CorporationPMA · 2024-09-03
Bulkamid Urethral Bulking System · Boston Scientific CorporationPMA · 2024-07-30
COAPTITE Injectable Implant · Merz North America, Inc.PMA · 2024-07-10
Deflux® Injectable Gel · Palette Life SciencesPMA · 2024-05-31
Coaptite Injectable Implant · Merz North America, Inc.PMA · 2024-05-10
Coaptite Injectable Implant · Merz North America, Inc.PMA · 2024-01-25
Durasphere® Injectable Bulking Agent · Carbon Medical Technologies, Inc.PMA · 2024-01-18
Bulkamid Urethral Bulking System · Boston Scientific CorporationPMA · 2023-12-18
Deflux® Injectable Gel · Palette Life SciencesPMA · 2023-12-07
Solesta® Injectable Gel · Palette Life SciencesPMA · 2023-12-07
COAPTITE Injectable Implant · Merz North America, Inc.PMA · 2023-10-12
Coaptite Injectable Implant · Merz North America, Inc.PMA · 2023-09-20
COAPTITE Injectable Implant · Merz North America, Inc.PMA · 2023-09-13
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.