Dutch Ophthalmic USA, Inc.
Dutch Ophthalmic USA, Inc. holds FDA 510(k) medical device clearances, first cleared 1990, most recent 2001, with 3 FDA device recalls on record.
Top product codes for Dutch Ophthalmic USA, Inc.
FDA recalls by Dutch Ophthalmic USA, Inc.
- Z-2097-2021 — Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product Code: 7510.ALC
- 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
- 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Dutch Ophthalmic USA, Inc.
- K012821 — D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM
- K010082 — D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM
- K983797 — D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM
- K980636 — FIBER OPTIC ENDOILLUMINATION PROBE
- K973229 — D.O.R.C. HEXON ILLUMINATION SYSTEM
- K973757 — D.O.R.C. SOLUX LIGHT SOURCE
- K962135 — D.O.R.C. MICRODIATHERMY SYSTEM
- K954842 — D.O.R.C. VFI/VFE SYSTEM
- K940373 — OPHTHALMIC CRYO UNIT
- K902491 — ECKHARDT TEMPORARY KERATOPROSTHESIS
Data sourced from openFDA. This site is unofficial and independent of the FDA.