Panels › Ear, Nose, Throat › Product code NHB · Class 2
Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Regulation 874.3620
2510(k)s in 12 months (16 all time)
0recalls in 12 months (15 all time)
14recalls that name a 510(k)
Top companies in NHB
| Company | 510(k)s | Recalls |
|---|---|---|
| Stryker Corporation | 0 | 14 |
| Spirair, Inc. | 4 | 0 |
| Spirox, Inc. | 3 | 0 |
| 3-D Matrix, Inc. | 1 | 1 |
| Entellus Medical, Inc. (Aka Stryker Ent) | 1 | 0 |
| ETHICON, Inc. | 1 | 0 |
| Hemostasis, LLC | 1 | 0 |
| Macropore Biosurgery, Inc. | 1 | 0 |
| Medtronic, Inc. | 1 | 0 |
| Medtronic Xomed | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 28, 2025 | Stryker Corporation Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S Open, Classified |
NHB | K070715 |
| Mar 28, 2025 | Stryker Corporation Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S Open, Classified |
NHB | K070715 |
| Mar 28, 2025 | Stryker Corporation Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S Open, Classified |
NHB | K070715 |
| Mar 28, 2025 | Stryker Corporation Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte plus 8cm Catalog Number 5400-030-008ITL Open, Classified |
NHB | K070715 |
| Mar 28, 2025 | Stryker Corporation Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plus 4cm Catalog Number 5400-030-004ITL Open, Classified |
NHB | K070715 |
| Mar 28, 2025 | Stryker Corporation Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS) Open, Classified |
NHB | K070715 |
| Mar 28, 2025 | Stryker Corporation Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITL Open, Classified |
NHB | K070715 |
| Mar 28, 2025 | Stryker Corporation Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL Open, Classified |
NHB | K070715 |
| Mar 28, 2025 | Stryker Corporation Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-004ITL Open, Classified |
NHB | None listed |
| Mar 28, 2025 | Stryker Corporation Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-008ITL Open, Classified |
NHB | K070715 |
| Mar 28, 2025 | Stryker Corporation Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL Open, Classified |
NHB | K070715 |
| Mar 28, 2025 | Stryker Corporation Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL Open, Classified |
NHB | K070715 |
| Mar 28, 2025 | Stryker Corporation Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL Open, Classified |
NHB | K070715 |
| Mar 28, 2025 | Stryker Corporation Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL Open, Classified |
NHB | K070715 |
| Dec 2, 2019 | 3-D Matrix, Inc. PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006 Terminated |
NHB | K183015 |
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