Product code NBE
- Device name
- Sealant, Polymerizing
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- SU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P150016S028 | TRIDYNE™ Vascular Sealant | Neomend, Inc. | 2026-03-12 |
| P010047S073 | PROGEL™ Pleural Air Leak Sealant | Neomend, Inc. | 2026-03-12 |
| P150016S027 | TRIDYNE™ Vascular Sealant | Neomend, Inc. | 2025-12-18 |
| P030039S032 | Coseal Applicator Tips | Baxter Bio Science | 2025-12-18 |
| P010047S072 | PROGEL™ Pleural Air Leak Sealant | Neomend, Inc. | 2025-12-18 |
| P030039S031 | Coseal Spray Set | Baxter Bio Science | 2025-08-21 |
| P100030S021 | Preveleak Surgical Sealant | Baxter Healthcare Corporation | 2025-07-10 |
| P150016S026 | TRIDYNE™ Vascular Sealant | Neomend, Inc. | 2025-06-18 |
| P010047S071 | PROGEL™ Pleural Air Leak Sealant | Neomend, Inc. | 2025-06-18 |
| P150016S025 | TRIDYNE™ Vascular Sealant | Neomend, Inc. | 2025-05-09 |
| P010047S070 | PROGEL Pleural Air Leak Sealant | Neomend, Inc. | 2025-05-09 |
| P100030S020 | Preveleak Surgical Sealant 4mL; Preveleak Delivery Tips 10 PK | Baxter Healthcare Corporation | 2025-04-11 |
| P030039S030 | Coseal Surgical Sealant | Baxter Bio Science | 2025-04-11 |
| P100030S019 | Preveleak Surgical Sealant, Preveleak 10-Pack delivery Tips | Baxter Healthcare Corporation | 2024-06-06 |
| P150016S024 | TRIDYNE™ Vascular Sealant | Neomend, Inc. | 2024-03-05 |
| P010047S069 | PROGEL™ Pleural Air Leak Sealant | Neomend, Inc. | 2024-03-05 |
| P100030S018 | Preveleak Surgical Sealant, Preveleak I 0-pack delivery tips | Baxter Healthcare Corporation | 2023-11-29 |
| P100030S017 | Preveleak Surgical Sealant | Baxter Healthcare Corporation | 2023-04-28 |
| P030039S028 | Coseal Surgical Sealant, Coseal Spray Set | Baxter Bio Science | 2023-02-23 |
| P150016S023 | TRIDYNE™ Vascular Sealant | Neomend, Inc. | 2023-02-07 |
| P010047S068 | PROGEL™ Pleural Air Leak Sealant | Neomend, Inc. | 2023-02-07 |
| P150016S022 | TRIDYNE Vascular Sealant | Neomend, Inc. | 2022-09-07 |
| P010047S067 | PROGEL Pleural Air Leak Sealant | Neomend, Inc. | 2022-09-06 |
| P010047S065 | PROGEL Pleural Air Leak Sealant | Neomend, Inc. | 2022-02-09 |
| P100030S016 | Preveleak Surgical Sealant, Preveleak Delivery Tips - 1O pack | Baxter Healthcare Corporation | 2021-12-09 |
| P030039S027 | Coseal Surgical Sealant; Coseal Spray Set | Baxter Bio Science | 2021-10-27 |
| P150016S021 | Tridyne™ Vascular Sealant | Neomend, Inc. | 2021-09-15 |
| P010047S066 | Progel™ Pleural Air Leak Sealant | Neomend, Inc. | 2021-09-15 |
| P150016S019 | Tridyne Vascular Sealant | Neomend, Inc. | 2021-08-17 |
| P010047S063 | Progel Pleural Air Leak Sealant | Neomend, Inc. | 2021-08-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 25413765583586 | PREVELEAK SURGICAL SEALANT | Baxter Healthcare Corporation | 2022-02-22 |
| 25413765583524 | PREVELEAK SURGICAL SEALANT | Baxter Healthcare Corporation | 2022-02-22 |
| 05413765583582 | PREVELEAK SURGICAL SEALANT | Baxter Healthcare Corporation | 2022-02-22 |
| 05413765583520 | PREVELEAK SURGICAL SEALANT | Baxter Healthcare Corporation | 2022-02-22 |
| 25413765583609 | PREVELEAK SURGICAL SEALANT | Baxter Healthcare Corporation | 2021-06-01 |
| 25413765583593 | PREVELEAK SURGICAL SEALANT | Baxter Healthcare Corporation | 2021-06-01 |
| 05413765583605 | PREVELEAK SURGICAL SEALANT | Baxter Healthcare Corporation | 2021-06-01 |
| 05413765583599 | PREVELEAK SURGICAL SEALANT | Baxter Healthcare Corporation | 2021-06-01 |
| 05413765583414 | COSEAL SPRAY SET | BAXTER HEALTHCARE CORPORATION | 2020-09-30 |
| 35413765583415 | COSEAL SPRAY SET | BAXTER HEALTHCARE CORPORATION | 2020-09-30 |
| 00801741099380 | Tridyne | NEOMEND, INC. | 2018-10-31 |
| 00801741099366 | Tridyne | NEOMEND, INC. | 2018-10-31 |
| 20801741099377 | Tridyne™ Vascular Sealant Standard Spray Tips | NEOMEND, INC. | 2018-10-31 |
| 10801741099370 | Tridyne | NEOMEND, INC. | 2018-10-31 |
| 00085412083322 | Coseal Surgical Sealant Replacement Applicator | BAXTER HEALTHCARE CORPORATION | 2017-10-09 |
| 00850868002049 | PreveLeak™ Surgical Sealant | Tenaxis Medical, Inc. | 2015-12-31 |
| 00850868002056 | PreveLeak™ 10 pack Tips | Tenaxis Medical, Inc. | 2015-12-31 |
| 05413765404627 | Coseal Surgical Sealant | BAXTER HEALTHCARE CORPORATION | 2015-06-10 |
| 05413765404634 | Coseal Surgical Sealant | BAXTER HEALTHCARE CORPORATION | 2015-05-05 |
| 05413765404610 | Coseal Surgical Sealant | BAXTER HEALTHCARE CORPORATION | 2015-05-04 |
| 30705031133109 | ETHICON OMNEX | ETHICON INC. | 2014-09-20 |
| 10705031133105 | ETHICON OMNEX | Ethicon Inc. | 2014-09-20 |
| 00850868002025 | PreveLeak™ Surgical Sealant | Tenaxis Medical, Inc. | 2014-09-15 |
| 00850868002032 | PreveLeak™ Surgical Sealant | Tenaxis Medical, Inc. | 2014-09-15 |
| 00850868002063 | PreveLeak™ Surgical Sealant | Tenaxis Medical, Inc. | 2014-09-15 |
| 20801741010037 | Progel™ Applicator Spray Tips | NEOMEND, INC. | 2014-09-12 |
| 00801741010026 | Progel | NEOMEND, INC. | 2014-09-12 |
| 00801741010019 | Progel | NEOMEND, INC. | 2014-09-12 |
| 00801741010002 | Progel | NEOMEND, INC. | 2014-09-12 |
| 10801741010030 | Progel | NEOMEND, INC. | 2014-09-12 |