Company ยท NL
Polyganics B.V.,
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2014. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 23, 2014 | K141816 | HEMOPORE Polyganics B.V.,, NL | LYA |
| Aug 7, 2014 | K141423 | NASOPORE-FD Polyganics B.V.,, NL | LYA |
| Oct 20, 2011 | K112267 | NEUROLAC(R) NERVE GUIDE Polyganics B.V.,, NL | JXI |
| May 7, 2007 | K070715 | NASOPORE EAR Polyganics B.V.,, NL | NHB |
| Oct 18, 2006 | K062540 | NASOPORE EAR, MODELS ND04, ND05 Polyganics B.V.,, NL | KCN |
| Nov 21, 2005 | K052099 | NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ Polyganics B.V.,, NL | LYA |
| May 4, 2005 | K050573 | NEUROLAC NERVE GUIDE Polyganics B.V.,, NL | JXI |
| Nov 8, 2004 | K042811 | VIVOSORB SHEET, MODEL FS01 Polyganics B.V.,, NL | FTL |
| Oct 10, 2003 | K032115 | NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03 Polyganics B.V.,, NL | JXI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||