Panels › Ear, Nose, Throat › Product code EPP · Class 1
Splint, Nasal
Regulation 874.5800
0510(k)s in 12 months (15 all time)
0recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in EPP
| Company | 510(k)s | Recalls |
|---|---|---|
| Exmoor Plastics , Ltd. | 4 | 0 |
| Medtronic Xomed, Inc. | 0 | 2 |
| Xomed, Inc. | 2 | 0 |
| American Silk Sutures, Inc. | 1 | 0 |
| Hood Laboratories | 1 | 0 |
| Microbio-Medics, Inc. | 1 | 0 |
| Micromed Development Corp. | 1 | 0 |
| Microtek Medical, Inc. | 1 | 0 |
| Richards Medical Co., Inc. | 1 | 0 |
| Ronald D. Shippert, M.D. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 17, 2011 | Medtronic Xomed, Inc. Recall of Alcohol Pads contained in the following kits distributed by Medtronic:
***REF 1529100***Thermasplint Kit, Small***X5***.
***REF 1529110***Thermasplint Kit, Medium***X5***.
Terminated |
EPP | None listed |
| Mar 17, 2011 | Medtronic Xomed, Inc. An external nasal splint is a rigid or partially rigid device intended for the use externally for immobilization of part of the nose.
An external nasal splint is a rigid or partially rigid device in Terminated |
EPP | None listed |
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