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ConMed Inflation Device

ATRION MEDICAL PRODUCTS, INC. · Model QL® 6015 · UDI-DI 00653405052350

KOEMAV Prescription
10
510(k) clearances
222
Adverse events
3
Recalls
64
Facilities

Description

Inflation Device: 60mL, 15atm

Recalls

DateFirmReason
2019-01-04Cook Inc.The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
2019-01-04Cook Inc.The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
2005-08-01Cook Urological, Inc.Mislabeled as to size.

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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.