Plymouth, GB · 5 510(k) clearances · 4 PMAs · 3 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| FRO | Dressing, Wound, Drug | Unclassified | Unknown | 3 | 2023-10-26 |
| OMD | Cutaneous Tissue Adhesive With Mesh | Class II | General, Plastic Surgery | 1 | 2022-05-23 |
| MPN | Tissue Adhesive For The Topical Approximation Of Skin | Class II | General, Plastic Surgery | 1 | 2020-03-09 |
| Date | PMA # | Trade name | Type | Code | Device name | Specialty |
|---|---|---|---|---|---|---|
| 2026-01-14 | P220024-S005 | LIQUIFIX FIX8 Hernia Mesh Fixation (HMF) Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device | Normal 180 Day Track No User Fee | PLJ | Tissue Adhesive Internal Use | General, Plastic Surgery |
| 2023-12-14 | P220024-S004 | LIQUIFIX FIX8 Laparoscopic Hernia Mesh Fixation Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device | Real-Time Process | PLJ | Tissue Adhesive Internal Use | General, Plastic Surgery |
| 2023-07-28 | P220024-S001 | LIQUIFIX FIX8 Laparoscopic Hernia Mesh Fixation Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device | Normal 180 Day Track No User Fee | PLJ | Tissue Adhesive Internal Use | General, Plastic Surgery |
| 2023-06-02 | P220024 | LIQUIFIX FIX8 Hernia Mesh Fixation (HMF) Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device | Original | PLJ | Tissue Adhesive Internal Use | General, Plastic Surgery |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-10-01 | Class II | Ongoing | Z-0619-2025 | MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLINE MOXORB EXTRA ALBINATE WOUND DRESSING 4X8 … | — | Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier. |
| 2024-10-01 | Class II | Ongoing | Z-0618-2025 | McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for moderate to heavily exuding chronic and acu… | — | Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier. |
| 2024-10-01 | Class II | Ongoing | Z-0617-2025 | Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicated for moderate to he… | — | Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2023-10-26 | K213473 | Antimicrobial Gelling Fiber Dressing with PHMB | FRO | Unclassified | Unknown |
| 2023-04-05 | K223310 | Antimicrobial Silicone PHMB Foam Wound Dressing | FRO | Unclassified | Unknown |
| 2022-05-23 | K211878 | LiquiBand XL | OMD | Class II | General, Plastic Surgery |
| 2021-05-12 | K210974 | High Performance Antimicrobial Gelling Fiber with Silver | FRO | Unclassified | Unknown |
| 2020-03-09 | K183570 | LiquiBand Plus | MPN | Class II | General, Plastic Surgery |