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Southmedic, Inc.

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
10
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0279-2023Class IISouthmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EOOctober 27, 2022
Z-2141-2021Class IIOxyMask O2 Adult REF OM-1125-14May 25, 2021
Z-1892-2018Class IISouthmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medicalNovember 6, 2017
Z-1288-2018Class IISouthmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case. MinimaOctober 17, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K222511Oxy2ProNovember 21, 2023
K131410CO2/O2 NASAL CANNULA (WITH 4 (10CM) O2 AND CO2 TUBE), CO2/O2 NASAL CANNULA (WITH 8 (240CM) O2 AND 4 January 13, 2014
K101953SMDIA-1000January 7, 2011
K014211OXYARM CO2June 11, 2002
K945993VAPOFILFebruary 22, 1995
K923265FUNNEL ADAPTORMarch 18, 1993
K863318AEROSOL-TSeptember 11, 1986
K861839VAPOFILMay 21, 1986
K860545VAPORIZER SPACERApril 17, 1986
K843993ANAESLOCK THREE VAPORIZER INTERLOCK HVA003November 15, 1984