Panels › Ear, Nose, Throat › Product code ERA · Class 1
Otoscope
Regulation 874.4770
0510(k)s in 12 months (56 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in ERA
| Company | 510(k)s | Recalls |
|---|---|---|
| Rudolf Riester GmbH & Co. KG | 9 | 0 |
| Welch Allyn, Inc. | 9 | 0 |
| Jedmed Instrument Co. | 4 | 0 |
| Pedia Pals, Inc. | 3 | 0 |
| Artiberia | 2 | 0 |
| Conphar, Inc. | 2 | 0 |
| Introspect, Inc. | 2 | 0 |
| Oticon Corp. | 2 | 0 |
| Baxter Healthcare Corporation | 0 | 1 |
| Blue Focus | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 11, 2025 | Baxter Healthcare Corporation 2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600 Open, Classified |
ERA | None listed |
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