Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in CanadaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Southmedic with 10 510(k) clearances and 4 device recalls. The most recent is a 510(k) clearance dated Nov 21, 2023: Oxy2Pro.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Nov 21, 2023 | Oxy2ProK222511 · CCK | 510(k) clearances |
| Oct 27, 2022 | Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EOClass II · Upon review of its batch record, Southmedic identified that lot # W92761 was not sent out for sterilization, and was ins | Device recalls |
| May 25, 2021 | OxyMask O2 Adult REF OM-1125-14Class II · Potential for oxygen tubing to disconnect from mask or loosen. Disconnected tubing results in a loss of device functi | Device recalls |
| Nov 6, 2017 | Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures for preparation, scraping anClass II · Scalpels lot contains non-sterile products labeled as sterile. | Device recalls |
| Oct 17, 2017 | Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case. Minimal contact, open oxygen delivery device fClass II · Potential for loose or missing CO2 diffusers which could result in a non-functioning mask. | Device recalls |
| Jan 13, 2014 | CO2/O2 NASAL CANNULA (WITH 4 (10CM) O2 AND CO2 TUBE), CO2/O2 NASAL CANNULA (WITH 8 (240CM) O2 AND 4 (10CM) CO2 TUBE),K131410 · CCK | 510(k) clearances |
| Jan 7, 2011 | SMDIA-1000K101953 · CAF | 510(k) clearances |
| Jun 11, 2002 | OXYARM CO2K014211 · CCK | 510(k) clearances |
| Feb 22, 1995 | VAPOFILK945993 · CAD | 510(k) clearances |
| Mar 18, 1993 | FUNNEL ADAPTORK923265 · CAD | 510(k) clearances |
| Sep 11, 1986 | AEROSOL-TK863318 · BZA | 510(k) clearances |
| May 21, 1986 | VAPOFILK861839 · CAD | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
