ClearanceBrief
Company ยท US

A-M Systems, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2013. Name variants (Inc, Corp, punctuation) are merged.

3510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
1recalls that name a 510(k)

Product codes

CodeDeviceRecords
CAHFilter, Bacterial, Breathing-Circuit4
BYXTubing, Pressure And Accessories1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jun 21, 2013K130664HYRDROMAX HMEF
A-M Systems
CAH
Jun 29, 2007K063526A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER
A-M Systems, Inc.
CAH
Nov 14, 2000K000654VBMAX
A-M Systems, Inc.
CAH

Latest recalls

DateFirm and productCodeLinked 510(k)
Aug 10, 2018A M Systems Inc
Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer. This tubing is supplied non-sterile P/N: 1024920 Rev. 01 Low temperature smooth interior tubing is a disposable pulmonary equi
Terminated
BYXNone listed
Jan 11, 2012A M Systems Inc
ViroMax viral/bacterial filter. The filter reduces the risk of infection due to cross-contamination between patients For use on all patient populations in conjunction with other respiratory devices co
Terminated
CAHK063526
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