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LiNA OperaScope™ Tubing & Drape kit

Lina Medical ApS · Model OP-TDK-6 · UDI-DI 05708265010585

NVT Prescription
0
510(k) clearances
1
Adverse events
1
Recalls
19
Facilities

Description

Tubing & drape for hysteroscopy

Recalls

DateFirmReason
2024-10-21Karl Storz EndoscopyDue to improper labeling of products. An intended use on the label has not been reviewed and approved by FDA for distribution in the U.S.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.