Southmedic, Inc.
Southmedic, Inc. holds FDA 510(k) medical device clearances, first cleared 1984, most recent 2023, with 4 FDA device recalls on record.
Top product codes for Southmedic, Inc.
FDA recalls by Southmedic, Inc.
- Z-0279-2023 — Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO
- Z-2141-2021 — OxyMask O2 Adult REF OM-1125-14
- Z-1892-2018 — Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures for preparation, scraping and/or cutting of tissue.
- Z-1288-2018 — Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case. Minimal contact, open oxygen delivery device for use with USP medical grade oxygen and for monitoring breathing by providing a means to sample exhaled CO2.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Southmedic, Inc.
- K222511 — Oxy2Pro
- K131410 — CO2/O2 NASAL CANNULA (WITH 4 (10CM) O2 AND CO2 TUBE), CO2/O2 NASAL CANNULA (WITH 8 (240CM) O2 AND 4 (10CM) CO2 TUBE),
- K101953 — SMDIA-1000
- K014211 — OXYARM CO2
- K945993 — VAPOFIL
- K923265 — FUNNEL ADAPTOR
- K863318 — AEROSOL-T
- K861839 — VAPOFIL
- K860545 — VAPORIZER SPACER
- K843993 — ANAESLOCK THREE VAPORIZER INTERLOCK HVA003
Data sourced from openFDA. This site is unofficial and independent of the FDA.