Panels › Ophthalmic › Product code HMR · Class 1
Marker, Ocular
Regulation 886.4570
0510(k)s in 12 months (5 all time)
0recalls in 12 months (6 all time)
0recalls that name a 510(k)
Top companies in HMR
| Company | 510(k)s | Recalls |
|---|---|---|
| Aspen Surgical Products, Inc. | 0 | 6 |
| Chiron Vision Corp. | 1 | 0 |
| CooperVision, Inc. | 1 | 0 |
| Innomed Corp. | 1 | 0 |
| Myocure, Inc. | 1 | 0 |
| Refractec, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 16, 2011 | Aspen Surgical Products, Inc. Walcott Rx Products, Surgical Division, Corneal Marking Pad, REF RX40490, Sterile. For use in ophthalmic surgery. Terminated |
HMR | None listed |
| Feb 16, 2011 | Aspen Surgical Products, Inc. Viscot Medical, LLC., Vismark Gentian Violet Marking Pad, Rx Only, Sterile, REF GV1200S. For use in ophthalmic surgery. Terminated |
HMR | None listed |
| Feb 16, 2011 | Aspen Surgical Products, Inc. CYNACON OcuSOFT LASIK Marker Pads, REF 750-093, Rx Only, Sterile. For use in ophthalmic surgery. Terminated |
HMR | None listed |
| Feb 16, 2011 | Aspen Surgical Products, Inc. Eagle Labs Corneal Marking Pad, Gentian Violet, REF 63-001, Sterile. For use in ophthalmic surgery. Terminated |
HMR | None listed |
| Feb 16, 2011 | Aspen Surgical Products, Inc. Aspen Surgical, Corneal Marking Pad, Gentian Violet Ink, REF 40490, Rx only, Sterile. For use in ophthalmic surgery. Terminated |
HMR | None listed |
| Feb 16, 2011 | Aspen Surgical Products, Inc. Oasis Corneal Marking Pad, REF 0441, Rx only, Sterile. For use in ophthalmic surgery. Terminated |
HMR | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.