510(k) K070715 ยท NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable
NASOPORE EAR
| Applicant | Polyganics B.V.,, Groningen, NL |
| Decision | Substantially Equivalent, May 7, 2007 |
| Received | Mar 14, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070715
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 28, 2025 | Stryker Corporation Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL Open, Classified |
NHB | None listed |
| Mar 28, 2025 | Stryker Corporation Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL Open, Classified |
NHB | None listed |
| Mar 28, 2025 | Stryker Corporation Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL Open, Classified |
NHB | None listed |
| 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 | 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 | None listed |
| 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 | None listed |
| Mar 28, 2025 | Stryker Corporation Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITL Open, Classified |
NHB | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| Mar 28, 2025 | Stryker Corporation Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S Open, Classified |
NHB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.