Dutch Ophthalmic USA, Inc.
Exeter, NH, US
DUTCH OPHTHALMIC USA, INC. appears in FDA device records in Exeter, NH. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Dutch Ophthalmic USA, Inc. between 1990 and 2001. The busiest year on record is 1996, with 2. The most recent is 2001, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 1 |
| 1994 | 1 |
| 1996 | 2 |
| 1997 | 2 |
| 1998 | 1 |
| 1999 | 1 |
| 2001 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K012821 | D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM | HRN | Substantially Equivalent | |
| K010082 | D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM | HQE | Substantially Equivalent | |
| K983797 | D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM | HQE | Substantially Equivalent | |
| K980636 | FIBER OPTIC ENDOILLUMINATION PROBE | FFS | Substantially Equivalent | |
| K973229 | D.O.R.C. HEXON ILLUMINATION SYSTEM | MPA | Substantially Equivalent | |
| K973757 | D.O.R.C. SOLUX LIGHT SOURCE | MPA | Substantially Equivalent | |
| K962135 | D.O.R.C. MICRODIATHERMY SYSTEM | HQO | Substantially Equivalent | |
| K954842 | D.O.R.C. VFI/VFE SYSTEM | KYG | Substantially Equivalent | |
| K940373 | OPHTHALMIC CRYO UNIT | HPS | Substantially Equivalent | |
| K902491 | ECKHARDT TEMPORARY KERATOPROSTHESIS | MLP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1222074 | 3007916166 | DUTCH OPHTHALMIC USA, INC. | 10 CONTINENTAL DRIVE, Exeter, NH 03833 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KYGDevice, Irrigation, Ocular Surgery
- MPAEndoilluminator
- FFSImage, Illumination, Fiberoptic, For Endoscope
- HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered
- MLPKeratoprosthesis, Temporary Implant, Surgical Use
- HQOUnit, Cautery, Thermal, Ac-Powered
- HPSUnit, Cryophthalmic
- HRNUnit, Cryophthalmic, Ac-Powered
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2097-2021 | Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product Code: 7510.ALC | Barcode label extended expiration date. Barcode located at the short side of the outer box shows 2025-10-27 when scanned, while the correct expiry date is 2024-10-01 | Class II | Open, Classified | |
| Z-2091-2021 | Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, product is 1281.B1D06 | Mislabeled: 1281.B1D Disposable Replacement Backflush Brush Needles label states (20 gauge/0.9 mm) instead of the correct size of 23 gauge/0.6 mm and the correct product code 1281.B1D06 | Class II | Terminated | |
| Z-2252-2021 | 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. | Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain