Panels › General, Plastic Surgery › Product code HMT · Class 2
Drape, Patient, Ophthalmic
Regulation 878.4370
0510(k)s in 12 months (7 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in HMT
| Company | 510(k)s | Recalls |
|---|---|---|
| Alcon Research, Ltd. | 0 | 1 |
| Angiosystems, Inc. | 1 | 0 |
| Charles Atkins & Co. | 1 | 0 |
| CooperVision, Inc. | 1 | 0 |
| Solos Ophthalmology | 1 | 0 |
| Sur-Tech, Inc. | 1 | 0 |
| Treace Medical, Inc. | 1 | 0 |
| Visitec Co. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 14, 1995 | K945738 | VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE Visitec Co. | HMT |
| Feb 6, 1991 | K905460 | STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY Angiosystems, Inc. | HMT |
| Jul 31, 1987 | K872620 | SOLOS EYESITE DRAPES Solos Ophthalmology | HMT |
| May 18, 1987 | K871706 | OPTHA PREP Treace Medical, Inc. | HMT |
| Feb 13, 1986 | K854613 | SURGICAL DRAPES, OPHTHALMIN Charles Atkins & Co. | HMT |
| Jun 8, 1983 | K831340 | DRAIN-R-DRAPE(EYE Sur-Tech, Inc. | HMT |
| Apr 6, 1983 | K830822 | EYE DRAPE CooperVision, Inc., GB | HMT |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.