NBE · Sealant, Polymerizing
· Class 3
Overview
| Product Code | NBE |
|---|---|
| Device Name | Sealant, Polymerizing |
| Device Class | Class 3 |
| Review Panel | |
| Implant | Yes |
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P150016 | TRIDYNE VASCULAR SEALANT | Neomend, Inc. | Apr 11, 2016 | APPR |
| P100030 | ARTERX SURGICAL SEALANT | Baxter Healthcare Corporation | Mar 1, 2013 | APPR |
| P060029 | ETHICON OMNEX SURGICAL SEALANT | ETHICON, Inc. | Jun 3, 2010 | APWD |
| P010047 | PROGEL PLEURAL AIR LEAK SEALANT | Neomend, Inc. | Jan 14, 2010 | APPR |
| P030039 | COSEAL SURGICAL SEALANT | Baxter Bio Science | Dec 12, 2003 | APPR |
| P010022 | COSEAL SURGICAL SEALANT (COSEAL) | Angiotech Medical Device Technologies | Dec 14, 2001 | APWD |
| P990028 | FOCAL SEAL-L SYNTHETIC ABSORBABLE SEALANT | Genzyme Corp. | May 26, 2000 | APWD |
Top Applicants
- Neomend, Inc. — 2 clearances
- Angiotech Medical Device Technologies — 1 clearance
- Baxter Bio Science — 1 clearance
- Baxter Healthcare Corporation — 1 clearance
- ETHICON, Inc. — 1 clearance