Panels › Ear, Nose, Throat › Product code EQN · Class 2
Laryngoscope, Nasopharyngoscope
Regulation 874.4760
1510(k)s in 12 months (22 all time)
0recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in EQN
| Company | 510(k)s | Recalls |
|---|---|---|
| Kelleher Corp. | 6 | 0 |
| Machida America, Inc. | 4 | 0 |
| Jedmed Instrument Co. | 2 | 0 |
| Shiley, Inc. | 2 | 0 |
| Bomimed Inc | 0 | 1 |
| Conphar, Inc. | 1 | 0 |
| Eder Instrument Co, Inc. | 1 | 0 |
| Edward Weck, Inc. | 1 | 0 |
| Imm Enterprises , Ltd. | 1 | 0 |
| Intermed, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 6, 2019 | Karl Storz Endoscopy Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers:
1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC
2. 8401xx ser Terminated |
EQN | None listed |
| May 3, 2012 | Bomimed Inc BOMImed Reusable Integrated Fiber Optic Laryngoscope Blades, MacIntosh and Miller styles - all sizes. Instrument is used to aid with intubation. Terminated |
EQN | None listed |
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