Company ยท US
Dutch Ophthalmic USA, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 2001. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 2 |
| MPA | Endoilluminator | 2 |
| FFS | Image, Illumination, Fiberoptic, For Endoscope | 1 |
| HMX | Cannula, Ophthalmic | 1 |
| HPS | Unit, Cryophthalmic | 1 |
| HQC | Unit, Phacofragmentation | 1 |
| HQF | Laser, Ophthalmic | 1 |
| HQO | Unit, Cautery, Thermal, Ac-Powered | 1 |
| HRN | Unit, Cryophthalmic, Ac-Powered | 1 |
| KYG | Device, Irrigation, Ocular Surgery | 1 |
| MLP | Keratoprosthesis, Temporary Implant, Surgical Use | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 22, 2001 | K012821 | D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM Dutch Ophthalmic USA, Inc. | HRN |
| Mar 12, 2001 | K010082 | D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM Dutch Ophthalmic USA, Inc. | HQE |
| Mar 3, 1999 | K983797 | D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM Dutch Ophthalmic USA, Inc. | HQE |
| May 20, 1998 | K980636 | FIBER OPTIC ENDOILLUMINATION PROBE Dutch Ophthalmic USA, Inc. | FFS |
| Nov 25, 1997 | K973229 | D.O.R.C. HEXON ILLUMINATION SYSTEM Dutch Ophthalmic USA, Inc. | MPA |
| Nov 7, 1997 | K973757 | D.O.R.C. SOLUX LIGHT SOURCE Dutch Ophthalmic USA, Inc. | MPA |
| Aug 29, 1996 | K962135 | D.O.R.C. MICRODIATHERMY SYSTEM Dutch Ophthalmic USA, Inc. | HQO |
| Apr 15, 1996 | K954842 | D.O.R.C. VFI/VFE SYSTEM Dutch Ophthalmic USA, Inc. | KYG |
| Jul 18, 1994 | K940373 | OPHTHALMIC CRYO UNIT Dutch Ophthalmic USA, Inc. | HPS |
| Jun 26, 1990 | K902491 | ECKHARDT TEMPORARY KERATOPROSTHESIS Dutch Ophthalmic USA, Inc. | MLP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 14, 2021 | Dutch Ophthalmic USA, Inc. Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system
Product Code: 7510.ALC Open, Classified |
HQF | K031023 |
| Feb 25, 2021 | Dutch Ophthalmic USA, Inc. Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery
Product Number: labeled as 1281.B1D, product is 1281.B1D06 Terminated |
HMX | None listed |
| May 21, 2019 | Dutch Ophthalmic USA, Inc. The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g, Product Number 8525.201. Open, Classified |
HQC | K190875 |