ClearanceBrief
Company

Western a Scott Fetzer Co

FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.

0510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
3recalls that name a 510(k)

Product codes

CodeDeviceRecords
BZDVentilator, Non-Continuous (Respirator)3
CANRegulator, Pressure, Gas Cylinder3

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Oct 15, 2009Western - a Scott Fetzer Company
Medical Gas Yoke Assembly. Airgas Portable 4-Cylinder Manifold Cart Model #AGI-2238. The device is a medical gas yoke assembly which is used to connect gas cylinder post valves to equipment used for
Terminated
CANNone listed
Oct 15, 2009Western - a Scott Fetzer Company
Medical Gas Yoke Assembly. Airgas Portable 2-Cylinder Manifold Cart Model #AGI-2237. The device is a medical gas yoke assembly which is used to connect gas cylinder post valves to equipment used for
Terminated
CANNone listed
Oct 15, 2009Western - a Scott Fetzer Company
Medical Gas Yoke Assembly. Generic 4-Cylinder Manifold Cart Model #8070. The device is a medical gas yoke assembly which is used to connect gas cylinder post valves to equipment used for anesthesia
Terminated
CANNone listed
Oct 24, 2003Western a Scott Fetzer Co
Western Medica OPC Portable Oxygen Conserving Regulator, Model MDL-7609, 1/2 - 5 LPM, packaged under the Medline label.
Terminated
BZDK010747
Oct 24, 2003Western a Scott Fetzer Co
Western Medica OPC Portable Oxygen Conserving Regulator, Model LIN-7005, 1/2 - 5 LPM, packaged under the Lincare label.
Terminated
BZDK010747
Oct 24, 2003Western a Scott Fetzer Co
Western Medica OPC Portable Oxygen Conserving Regulator, Model OPC-830, 1/2 - 5 LPM, packaged under the Western Medica label.
Terminated
BZDK010747
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