Southmedic, Inc.
FDA Regulatory Profile
Southmedic, Inc. appears in FDA public data with 4 recalls, 10 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0279-2023, Class II) was initiated on Oct 27, 2022. Its most recent 510(k) clearance was granted on Nov 21, 2023.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 10
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0279-2023 | Class II | Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO | Oct 27, 2022 |
| Z-2141-2021 | Class II | OxyMask O2 Adult REF OM-1125-14 | May 25, 2021 |
| Z-1892-2018 | Class II | Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical | Nov 6, 2017 |
| Z-1288-2018 | Class II | Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case. Minima | Oct 17, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K222511 | Oxy2Pro | Nov 21, 2023 |
| K131410 | CO2/O2 NASAL CANNULA (WITH 4 (10CM) O2 AND CO2 TUBE), CO2/O2 NASAL CANNULA (WITH 8 (240CM) O2 AND 4 | Jan 13, 2014 |
| K101953 | SMDIA-1000 | Jan 7, 2011 |
| K014211 | OXYARM CO2 | Jun 11, 2002 |
| K945993 | VAPOFIL | Feb 22, 1995 |
| K923265 | FUNNEL ADAPTOR | Mar 18, 1993 |
| K863318 | AEROSOL-T | Sep 11, 1986 |
| K861839 | VAPOFIL | May 21, 1986 |
| K860545 | VAPORIZER SPACER | Apr 17, 1986 |
| K843993 | ANAESLOCK THREE VAPORIZER INTERLOCK HVA003 | Nov 15, 1984 |