Product code NBE ยท Class 3
Sealant, Polymerizing
0510(k)s in 12 months (0 all time)
0recalls in 12 months (11 all time)
0recalls that name a 510(k)
Top companies in NBE
| Company | 510(k)s | Recalls |
|---|---|---|
| Baxter Healthcare Corp | 0 | 5 |
| Baxter Bioscience | 0 | 3 |
| Baxter Healthcare Services L.P. | 0 | 1 |
| Mallinckrodt Manufacturing LLC | 0 | 1 |
| Neomend Inc | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 5, 2024 | Baxter Healthcare Corporation Baxter Preveleak Surgical Sealant, Product Codes: ADS201808 Open, Classified |
NBE | None listed |
| Jan 5, 2024 | Baxter Healthcare Corporation Baxter Coseal Premix, Surgical Sealant, Product Codes:
a) 934070;
b) 934071;
c) 934072 Open, Classified |
NBE | None listed |
| Jul 6, 2017 | Mallinckrodt Manufacturing LLC Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL REF 9006, STERILE R, Store at 2oC - 8oC
Adjunct to sutures in vascular surgery. Terminated |
NBE | None listed |
| May 31, 2016 | Baxter Healthcare Corp COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage. Terminated |
NBE | None listed |
| May 31, 2016 | Baxter Healthcare Corp COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage. Terminated |
NBE | None listed |
| May 31, 2016 | Baxter Healthcare Corp COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage. Terminated |
NBE | None listed |
| Sep 25, 2012 | Neomend Inc Progel Pleural Air Leak Sealant, Model #: PGPS002
Lot #: 111202-002
Product Usage:
The Progel Pleural Air Leak Sealant is indicated for application to visceral pleura during an open thoracotomy after Terminated |
NBE | None listed |
| May 16, 2012 | Baxter Healthcare Services L.P. Coseal Surgical Sealant.
Coseal is an adjunctive surgical sealant. Terminated |
NBE | None listed |
| Jul 2, 2010 | Baxter Bioscience Coseal Surgical Sealant 8mL, Product Codes: 934072 & 934075.
Indicated for use in vascular reconstructions to achieve adjunctive hemostasis. Terminated |
NBE | None listed |
| Jul 2, 2010 | Baxter Bioscience Coseal Surgical Sealant 4mL, Product Codes: 934071 & 934074.
Indicated for use in vascular reconstructions to achieve adjunctive hemostasis. Terminated |
NBE | None listed |
| Jul 2, 2010 | Baxter Bioscience Coseal Surgical Sealant 2mL, Product Codes: 934070 & 934073.
Indicated for use in vascular reconstructions to achieve adjunctive hemostasis. Terminated |
NBE | None listed |
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