Dutch Ophthalmic USA, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 10
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2097-2021 | Class II | Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product Co | April 14, 2021 |
| Z-2091-2021 | Class II | Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Pro | February 25, 2021 |
| Z-2252-2021 | Class II | The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectom | May 21, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K012821 | D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM | October 22, 2001 |
| K010082 | D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM | March 12, 2001 |
| K983797 | D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM | March 3, 1999 |
| K980636 | FIBER OPTIC ENDOILLUMINATION PROBE | May 20, 1998 |
| K973229 | D.O.R.C. HEXON ILLUMINATION SYSTEM | November 25, 1997 |
| K973757 | D.O.R.C. SOLUX LIGHT SOURCE | November 7, 1997 |
| K962135 | D.O.R.C. MICRODIATHERMY SYSTEM | August 29, 1996 |
| K954842 | D.O.R.C. VFI/VFE SYSTEM | April 15, 1996 |
| K940373 | OPHTHALMIC CRYO UNIT | July 18, 1994 |
| K902491 | ECKHARDT TEMPORARY KERATOPROSTHESIS | June 26, 1990 |