Isolyser Sharps Management System Sms

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K943626 ↗

FDA Product Code

FMI

Device Class

Class II

Regulation

21 CFR Part 880.5570

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Isolyser Orex Surgeon's Caps, Hoods, Bouffant Caps

  Class I

  FDA 510(k) K942200 Active Cleared 7 Aug 1995

• Orex(R) O.r Equipment Drapes

  Class II

  FDA 510(k) K945755 Active Cleared 25 May 1995

• Orex (18X18 X-Ray Detectable)

  Class I

  FDA 510(k) K940766 Active Cleared 19 Dec 1994

• Orex Surgeon's Vest

  Class II

  FDA 510(k) K961083 Active Cleared 23 Aug 1996

• Isolyser

  Unclassified

  FDA 510(k) K940765 Active Cleared 19 Dec 1994

• Orex Isolation Gown

  Class II

  FDA 510(k) K945223 Active Cleared 25 Apr 1995

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