Unna Boot Dressing W/Calamine

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K883224 ↗

FDA Product Code

FRO

Device Class

U

Advisory Committee

Unknown

FDA Decision

SN

• Tens Device for Relief of Chronic Pain, Modified

  Class II

  FDA 510(k) K924876 Active Cleared 1 Mar 1994

• John Bunn Neb-U-Lite II Medication Compressor with Disposable Nebulizer, Model #jbo-112-009

  Class II

  FDA 510(k) K970035 Active Cleared 1 Apr 1997

• Medicopaste Bandage with Calamine/Modification

  Class I

  FDA 510(k) K904904 Active Cleared 19 Mar 1991

• Cardisuny 501BIII

  Class II

  FDA 510(k) K901948 Active Cleared 17 Jul 1990

• Labtron Electromax Electronic Stethoscope Model No. 04-1060

  Class II

  FDA 510(k) K961857 Active Cleared 3 Jul 1996

• Cardisuny, 501BX

  Not classified

  FDA 510(k) K900849 Active Cleared 4 Apr 1990

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