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Reuter

MEDTRONIC XOMED, INC. · Model 14121 · UDI-DI 00763000282936

ETD Prescription
1
510(k) clearances
92
Adverse events
14
Recalls
36
Facilities

Description

VENT TUBE 14121 5PK REUTER BOB 1.02 FLPL

Recalls

DateFirmReason
2024-11-24Adept Medical LtdLack of 510(k) clearance.
2024-11-24Adept Medical LtdLack of 510(k) clearance.
2024-11-24Adept Medical LtdLack of 510(k) clearance.
2024-11-24Adept Medical LtdLack of 510(k) clearance.
2024-11-24Adept Medical LtdLack of 510(k) clearance.
2024-11-24Adept Medical LtdLack of 510(k) clearance.
2024-11-24Adept Medical LtdLack of 510(k) clearance.
2024-11-24Adept Medical LtdLack of 510(k) clearance.
2024-11-19Olympus Corporation of the AmericasPotential that Duravent Silicone Ventilation Tubes may contain incorrect product, specifically, 1.32 mm Tiny T Tubes (model: 70240076) instead of the intended Duravent Silicone Ven
2023-12-11Olympus Corporation of the AmericasThe expiration date is missing from the primary (inner) packaging. The secondary (outer) box label correctly states the expiration date of February 12, 2033, for this lot

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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.