Home › Device types › NBE
Sealant, Polymerizing
FDA product code NBE · Class 3 · Unknown
24
Registered devices
330
Adverse events
11
Recalls
0
510(k) clearances
Devices with this code
Progel — NEOMEND, INC.PREVELEAK SURGICAL SEALANT — Baxter Healthcare CorporationPreveLeak™ 10 pack Tips — Tenaxis Medical, Inc.PREVELEAK SURGICAL SEALANT — Baxter Healthcare CorporationTridyne — NEOMEND, INC.COSEAL SPRAY SET — BAXTER HEALTHCARE CORPORATIONCoseal Surgical Sealant — BAXTER HEALTHCARE CORPORATIONETHICON OMNEX — Ethicon Inc.PREVELEAK SURGICAL SEALANT — Baxter Healthcare CorporationCoseal Spray Set — Baxter Healthcare SAProgel — NEOMEND, INC.Coseal Surgical Sealant — BAXTER HEALTHCARE CORPORATIONPreveLeak™ Surgical Sealant — Tenaxis Medical, Inc.PreveLeak™ Surgical Sealant — Tenaxis Medical, Inc.Tridyne — NEOMEND, INC.Tridyne — NEOMEND, INC.Progel — NEOMEND, INC.Coseal Surgical Sealant — BAXTER HEALTHCARE CORPORATIONCoseal Surgical Sealant Replacement Applicator — BAXTER HEALTHCARE CORPORATIONCoseal Surgical Sealant Extended Applicator — BAXTER HEALTHCARE CORPORATIONProgel — NEOMEND, INC.PreveLeak™ Surgical Sealant — Tenaxis Medical, Inc.PREVELEAK SURGICAL SEALANT — Baxter Healthcare CorporationPreveLeak™ Surgical Sealant — Tenaxis Medical, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-12-06 | Baxter Healthcare Corporation | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align wi |
| 2023-12-06 | Baxter Healthcare Corporation | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align wi |
| 2016-05-12 | Baxter Healthcare Corp | Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of th |
| 2016-05-12 | Baxter Healthcare Corp | Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of th |
| 2016-05-12 | Baxter Healthcare Corp | Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of th |
| 2014-10-17 | Mallinckrodt Manufacturing LLC | Product was improperly labeled leading to improper storage. |
| 2012-08-13 | Neomend Inc | Product was distributed with an incorrect expiration date. Product was labeled with an expiration date of 2013-04 and should have been labeled with 2012-09. |
| 2011-07-28 | Baxter Healthcare Services L.P. | The recall is being conducted as a precautionary measure due to out of specification results observed at the 24 months time point (out of 24-month licensed shel |
| 2010-01-14 | Baxter Bioscience | The recall is being conducted as a precautionary measure due to out of specification results at the 18 month and 21 month time points (out of the 24 month licen |
| 2010-01-14 | Baxter Bioscience | The recall is being conducted as a precautionary measure due to out of specification results at the 18 month and 21 month time points (out of the 24 month licen |
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