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TCV-FAC-21W(SBF)(23060)

TOKYO GIKEN INC. · Model W132 · UDI-DI 04582539071271

EBR Prescription
3
510(k) clearances
5
Adverse events
3
Recalls
73
Facilities

Description

This device is intended to remove droplets scattered from the oral cavity. This equipment is an electrical powered suction pumps as suction source.

Recalls

DateFirmReason
2004-04-13Busse Hospital DisposablesFirm received complaints of "melting" at tubing connection. The connecting part of the Yankauer becomes soft after extended direct contact with the PVC tubing. This results in a sl
2004-04-13Busse Hospital DisposablesFirm received complaints of "melting" at tubing connection. The connecting part of the Yankauer becomes soft after extended direct contact with the PVC tubing. This results in a sl
2004-04-13Busse Hospital DisposablesFirm received complaints of "melting" at tubing connection. The connecting part of the Yankauer becomes soft after extended direct contact with the PVC tubing. This results in a sl

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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.