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Anodyne Surgical

Psi/Eye-Ko, Inc. · Model CQ1001 · UDI-DI 00840516130910

HNR
10
510(k) clearances
861
Adverse events
16
Recalls
279
Facilities

Description

Barraquer Needle Holder Standard Curved 10mm Jaws, w/Lock, Round Handle, SS

Recalls

DateFirmReason
2026-03-25Katalyst Surgical, LLCField Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25Katalyst Surgical, LLCField Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25Katalyst Surgical, LLCField Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25Katalyst Surgical, LLCField Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25Katalyst Surgical, LLCField Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25Katalyst Surgical, LLCField Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25Katalyst Surgical, LLCField Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25Katalyst Surgical, LLCField Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25Katalyst Surgical, LLCOphthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, pulling, or joining eye and/or surrounding
2026-03-25Katalyst Surgical, LLCField Safety Corrective Action for IFU in DEX Forceps and Scissors.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.