LMHFDA Class 3 · implantable
Implant, Dermal, For Aesthetic 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
1,028
Manufacturers
12
Flagged signals
40
Adverse-event reports
17,867
Code matrix
| FDA product code | LMH |
| Device class | Class 3 |
| Regulation | — |
| GMDN | — (crosswalk pending) |
| Implantable | Yes |
| 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 | 2014 | 7 | 665.1 | 4,006 |
| Other | 2010 | 94 | 429.3 | 39,689 |
| 2010 | 8 | 307.5 | 2,136 | |
| Other | 2011 | 3 | 221.7 | 457 |
| Other | 2011 | 10 | 207.9 | 1,859 |
| Other | 2010 | 8 | 190.0 | 1,323 |
| Other | 2012 | 60 | 177.6 | 10,360 |
| Other | 2011 | 4 | 177.3 | 537 |
| Other | 2010 | 4 | 177.3 | 537 |
| Other | 2009 | 28 | 127.6 | 3,395 |
| Other | 2011 | 43 | 127.2 | 5,261 |
| Other | 2013 | 42 | 124.3 | 5,015 |
| Other | 2013 | 5 | 103.9 | 412 |
| Other | 2012 | 5 | 103.9 | 412 |
| Other | 2014 | 4 | 83.1 | 248 |
| Other | 2010 | 4 | 68.2 | 202 |
| Other | 2013 | 3 | 51.2 | 102 |
| Other | 2011 | 17 | 50.3 | 773 |
| Other | 2011 | 53 | 47.1 | 2,347 |
| Other | 2014 | 53 | 32.8 | 1,602 |
| Other | 2010 | 35 | 31.1 | 990 |
| Other | 2015 | 10 | 29.6 | 248 |
| Other | 2011 | 6 | 27.3 | 127 |
| Other | 2012 | 9 | 26.6 | 197 |
| Other | 2012 | 29 | 25.8 | 666 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 3 family · 17,867 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| MERZ NORTH AMERICA, INC. | 373 | 2026 | — |
| Q-Med AB | 248 | 2026 | — |
| Allergan | 240 | 2025 | — |
| Teoxane S.A. | 51 | 2026 | — |
| Tiger Aesthetics Medical, LLC | 42 | 2025 | — |
| Prollenium Medical Technologies, Inc. | 23 | 2025 | — |
| Anika Therapeutics, Inc. | 20 | 2015 | — |
| Genzyme Biosurgery | 15 | 2014 | — |
| Colbar Lifescience , Ltd. | 5 | 2009 | — |
| Mentor Corp. | 5 | 1991 | — |
| SYMATESE | 5 | 2026 | — |
| CROMA-PHARMA GmbH | 1 | 2025 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
SCULPTRA AND SCULPTRA AESTHETIC · Q-Med ABPMA · 2026-04-15
Restylane® Refyne, Restylane® Defyne, Restylane® Kysse and Restylane® Contour · Q-Med ABPMA · 2026-04-14
RHA 2, RHA 3, RHA 4 · Teoxane S.A.PMA · 2026-04-07
RHA® Redensity, RHA® Redensity Mepi, RHA®2 and RHA®2 Mepi, RHA®3 and RHA®3 Mepi, RHA®4 and RHA® Dynamic Volume · Teoxane S.A.PMA · 2026-04-01
RHA® Redensity Mepi (also called RHA®1 Mepi), RHA®2 Mepi, RHA®3 Mepi, RHA® Dynamic Volume (formerly called RHA®4 Mepi) · Teoxane S.A.PMA · 2026-03-31
RADIESSE® Injectable Implant · Merz North America, Inc.PMA · 2026-03-31
RADIESSE® Injectable Implant · Merz North America, Inc.PMA · 2026-03-24
RADIESSE® Injectable Implant · Merz North America, Inc.PMA · 2026-03-24
P050052 RADIESSE® Injectable Implant; RADIESSE® Hands; RADIESSE® (+) Lidocaine; Jawline indication · Merz North America, Inc.PMA · 2026-03-24
RADIESSE® Injectable Implant · Merz North America, Inc.PMA · 2026-03-24
Restylane® Contour · Q-Med ABPMA · 2026-03-20
RADIESSE® Injectable Implant · Merz North America, Inc.PMA · 2026-03-18
RADIESSE® Injectable Implant · Merz North America, Inc.PMA · 2026-03-18
RESTYLANE INJECTABLE GEL · Q-Med ABPMA · 2026-03-12
Evolysse Smooth; Evolysse Form · SymatesePMA · 2026-02-27
Restylane Lyft with Lidocaine · Q-Med ABPMA · 2026-02-05
Restylane®-L 1 mL; Restylane® Lyft with Lidocaine 1 mL; Restylane® Eyelight 0.5 mL · Q-Med ABPMA · 2026-01-29
RHA® Redensity dermal filler · Teoxane S.A.PMA · 2026-01-14
RADIESSE® Injectable Implant · Merz North America, Inc.PMA · 2026-01-13
RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, Jawline indication · Merz North America, Inc.PMA · 2026-01-13
Restylane® Lyft with Lidocaine · Q-Med ABPMA · 2025-12-23
Revanesse Versa; Revanesse Versa+ (with lidocaine); Revanesse Lips+ (with lidocaine) · Prollenium Medical Technologies, Inc.PMA · 2025-12-22
Evolysse Injectable Hyaluronic Acid · SymatesePMA · 2025-12-19
Evolysse® FORM · SymatesePMA · 2025-12-18
RADIESSE INJECTABLE IMPLANT · Merz North America, Inc.PMA · 2025-12-12
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.