Camera, Television, Surgical, Without Audio
FDA product code FWB · Class I (low risk) · 21 CFR 878.4160 · General, Plastic Surgery
6510(k) clearances
0PMA approvals
2recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K934092 | Camera, Surgical and AccessoriesFWB · Traditional | Envision Medical Corp. | 01/07/1994SE |
| K902359 | Surgical Video Camera, Model 9500FWB · Traditional | Seitz Technical Products, Inc. | 07/12/1990SE |
| K884343 | Sony Color Video Cameras and AccessoriesFWB · Traditional | Sony Corp. of America | 11/01/1988SE |
| K871057 | Mc-Series Surgical CamerasFWB · Traditional | M.P. Video, Inc. | 04/03/1987SE |
| K855020 | Medical Dynamics CCD Solid State Video Camera 5930FWB · Traditional | Medline Industries, Inc. | 01/24/1986SE |
| K820829 | MedicamFWB · Traditional | M.P. Video, Inc. | 05/03/1982SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0824-2018 Class II | Camera System, Television, Surgical without audio Intended for transmission and…The radiated emission from the TruVidia" Wireless Receiver is above the normative accepted limits, in which… | Trumpf Medical Systems, Inc. | 12/15/2017Terminated |
| Z-2771-2015 Class II | Sony LMD-1951MD, Sony LMD1951MD/BS, Sony LMD-1951MC (Foreign) 19 inch medical grade…Tthe medical monitor has either not turned on or has lost image during clinical use. | Sony Medical Systems | 01/13/2015Terminated |