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General Hospital devices
268 product codes reviewed by the General Hospital panel. 15,652 510(k) clearances and 6,297 recalls in the FDA data, 69% of those recalls name a 510(k).
151510(k)s in 12 months
328recalls in 12 months
4,368recalls that name a 510(k)
Active product codes, Class I
| Code | Device | Class | 510(k)s, 12 mo | Recalls, 12 mo |
|---|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 1 | 17 | 3 |
| OXQ | Dressing Change Tray | 1 | 0 | 14 |
| FSA | Lift, Patient, Non-Ac-Powered | 1 | 0 | 10 |
| KGX | Tape And Bandage, Adhesive | 1 | 0 | 9 |
| LRJ | Disinfectant, Medical Devices | 1 | 0 | 4 |
| LZC | Medical Glove, Specialty | 1 | 1 | 1 |
| FNJ | Bed, Manual | 1 | 0 | 1 |
| FQM | Bandage, Elastic | 1 | 0 | 1 |
| KYW | Container, Liquid Medication, Graduated | 1 | 0 | 1 |
| KYZ | Syringe, Irrigating (Non Dental) | 1 | 0 | 1 |
| KZF | Device, Medical Examination, Ac Powered | 1 | 0 | 1 |
| LWH | Counter, Sponge, Surgical | 1 | 0 | 1 |
| LYZ | Vinyl Patient Examination Glove | 1 | 1 | 0 |
| MHW | Dressing, Compression | 1 | 0 | 1 |
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