Panels › Ear, Nose, Throat › Product code LYA · Class 1
Splint, Intranasal Septal
Regulation 874.4780
0510(k)s in 12 months (46 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in LYA
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Medical Products, Inc. | 4 | 0 |
| Spiway, LLC | 4 | 0 |
| Polyganics B.V., | 3 | 0 |
| Smith & Nephew Richards, Inc. | 3 | 0 |
| Carbylan Biosurgery | 2 | 0 |
| Invotec International, Inc. | 2 | 0 |
| Medtronic Xomed | 2 | 0 |
| Merocel Corp. | 2 | 0 |
| Porex Surgical, Inc. | 1 | 1 |
| ArthroCare Corporation | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 27, 2022 | GELITA MEDICAL GMBH ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM Terminated |
LYA | K060878 |
| Sep 22, 2006 | Porex Surgical, Inc. Porex Nostril Retainers, CAT #7241, Size 4, Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265 USA. Terminated |
LYA | None listed |
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