Panels › Ophthalmic › Product code HME · Class 1
Chair, Ophthalmic, Ac-Powered
Regulation 886.1140
0510(k)s in 12 months (16 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in HME
| Company | 510(k)s | Recalls |
|---|---|---|
| F. & F. Koenigkramer | 3 | 0 |
| Koken Mfg Company, Inc. | 2 | 0 |
| American Optical Corp. | 1 | 0 |
| Charles D. Bell, Inc. | 1 | 0 |
| Icor AB | 1 | 0 |
| Marco Ophthalmic, Inc. | 1 | 0 |
| Reliance Medical Products, Inc. | 1 | 0 |
| Sds Dental, Inc. | 1 | 0 |
| Storz Instrument Co. | 1 | 0 |
| Surgical Mechanical Research, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2023 | UFSK - International OSYS Gmbh UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of the patient during diagnostic and therapeutic treatments of temporary to short-term duration, especially in
ophthalmology
Open, Classified |
HME | None listed |
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