MOZFDA Class 3
Acid, Hyaluronic, Intraarticular
Device family · Unknown
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
312
Manufacturers
10
Flagged signals
48
Adverse-event reports
6,694
Code matrix
| FDA product code | MOZ |
| 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 | 2012 | 19 | 88.4 | 1,557 |
| Other | 2013 | 14 | 65.1 | 822 |
| Other | 2012 | 189 | 46.7 | 8,375 |
| Other | 2013 | 18 | 43.1 | 699 |
| Other | 2011 | 9 | 41.9 | 320 |
| Other | 2001 | 8 | 37.2 | 247 |
| 2009 | 7 | 37.1 | 210 | |
| Other | 2011 | 149 | 36.8 | 5,136 |
| Other | 2010 | 147 | 36.3 | 4,995 |
| Other | 2011 | 13 | 31.1 | 350 |
| Other | 2013 | 114 | 28.1 | 2,949 |
| 2010 | 5 | 26.4 | 98 | |
| Other | 2012 | 10 | 23.9 | 198 |
| Other | 2002 | 5 | 23.3 | 86 |
| Other | 2004 | 4 | 18.6 | 50 |
| Other | 2011 | 4 | 18.6 | 50 |
| Other | 2024 | 4 | 15.9 | 42 |
| Other | 1998 | 3 | 14.0 | 24 |
| Other | 1999 | 3 | 14.0 | 24 |
| Death | 2022 | 7 | 12.0 | 61 |
| Other | 2012 | 5 | 12.0 | 40 |
| Other | 2012 | 8 | 11.5 | 67 |
| Other | 2011 | 39 | 9.6 | 292 |
| Other | 2009 | 4 | 9.6 | 23 |
| Death | 2021 | 6 | 9.2 | 36 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 3 family · 6,694 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Seikagaku Corp. | 114 | 2026 | — |
| Sanofi Genzyme Corp. | 52 | 2025 | — |
| Ferring Pharmaceuticals, Inc. | 40 | 2025 | — |
| Anika Therapeutics, Inc. | 39 | 2023 | — |
| Fidia Farmaceutici S.p.A. | 21 | 2024 | — |
| Bioventus, LLC | 16 | 2025 | — |
| Ibsa Institut Biochimique SA | 14 | 2024 | — |
| Channel-Markers Medical, LLC | 8 | 2025 | — |
| Fidia Farmaceutici | 6 | 2025 | — |
| Mesoblast | 2 | 2025 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
GEL-ONE · Seikagaku Corp.PMA · 2026-04-09
DUROLANE · Bioventus, LLCPMA · 2025-12-23
SYNOJOYNT · MesoblastPMA · 2025-12-23
SUPARTZ FX; VISCO-3 · Seikagaku Corp.PMA · 2025-12-19
EUFLEXXA® (1% SODIUM HYALURONATE) · Ferring Pharmaceuticals, Inc.PMA · 2025-10-16
SUPARTZ FX · Seikagaku Corp.PMA · 2025-08-18
SUPARTZ FX; VISCO-3 · Seikagaku Corp.PMA · 2025-07-22
Gel-One · Seikagaku Corp.PMA · 2025-06-18
EUFLEXXA (1% SODIUM HYALURONATE) · Ferring Pharmaceuticals, Inc.PMA · 2025-05-28
TriVisc · Channel-Markers Medical, LLCPMA · 2025-05-20
GenVisc 850 · Channel-Markers Medical, LLCPMA · 2025-05-20
HYMOVIS ONE · Fidia FarmaceuticiPMA · 2025-04-09
Gel-One · Seikagaku Corp.PMA · 2025-01-17
Synvisc, Synvisc-One · Sanofi Genzyme Corp.PMA · 2025-01-02
HYMOVIS® (High Molecular Weight Viscoelastic Hyaluronan) · Fidia FarmaceuticiPMA · 2024-10-16
EUFLEXXA · Ferring Pharmaceuticals, Inc.PMA · 2024-09-23
EUFLEXXA · Ferring Pharmaceuticals, Inc.PMA · 2024-08-17
SUPARTZ FX, VISCO-3 · Seikagaku Corp.PMA · 2024-07-25
TRILURON® · Fidia Farmaceutici S.P.A.PMA · 2024-06-28
HYALGAN® · Fidia Farmaceutici S.P.A.PMA · 2024-06-28
HYMOVIS® · Fidia FarmaceuticiPMA · 2024-06-28
EUFLEXXA · Ferring Pharmaceuticals, Inc.PMA · 2024-04-06
EUFLEXXA · Ferring Pharmaceuticals, Inc.PMA · 2024-03-01
EUFLEXXA® (1% sodium hyaluronate) · Ferring Pharmaceuticals, Inc.PMA · 2024-02-02
Gelsyn-3 · Ibsa Institut Biochimique SAPMA · 2024-01-11
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.