Company ยท CA
Southmedic, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 2023. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
9recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 21, 2023 | K222511 | Oxy2Pro Southmedic, Inc., CA | CCK |
| Jan 13, 2014 | 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), Southmedic, Inc., CA | CCK |
| Jan 7, 2011 | K101953 | SMDIA-1000 Southmedic, Inc. | CAF |
| Jun 11, 2002 | K014211 | OXYARM CO2 Southmedic, Inc. | CCK |
| Feb 22, 1995 | K945993 | VAPOFIL Southmedic, Inc., CA | CAD |
| Mar 18, 1993 | K923265 | FUNNEL ADAPTOR Southmedic, Inc., CA | CAD |
| Sep 11, 1986 | K863318 | AEROSOL-T Southmedic, Inc., CA | BZA |
| May 21, 1986 | K861839 | VAPOFIL Southmedic, Inc., CA | CAD |
| Apr 17, 1986 | K860545 | VAPORIZER SPACER Southmedic, Inc., CA | CAD |
| Nov 15, 1984 | K843993 | ANAESLOCK THREE VAPORIZER INTERLOCK HVA003 Southmedic, Inc., CA | CAD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 23, 2022 | Southmedic, Inc. Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO Open, Classified |
GES | None listed |
| May 25, 2021 | Southmedic, Inc. OxyMask O2 Adult REF OM-1125-14 Open, Classified |
CCK | None listed |
| Jan 25, 2018 | Southmedic, Inc. 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 breath Terminated |
CCK | K014211 |
| Nov 6, 2017 | Southmedic, Inc. Southmedic Sterile Disposable Scalpel Rx only
Scalpels are intended to be used in various medical procedures for preparation, scraping and/or cutting of tissue. Terminated |
GDX | None listed |
| Jan 31, 2011 | Southmedic, Inc. Southmedic/Personna Safety Scalpel with Personna Plus Blades, Reorder No. 73-0615, Size #15, General Surgical Use, Sterile, unless package is damaged or opened., Southmedic Inc., 50 Alliance Blvd., Ba Terminated |
GDX | None listed |
| Jan 31, 2011 | Southmedic, Inc. Southmedic/Personna Safety Scalpel with Personna Plus Blades, Reorder No. 73-0611, Size #11, General Surgical Use, Sterile, unless package is damaged or opened., Southmedic Inc., 50 Alliance Blvd., Ba Terminated |
GDX | None listed |
| Jan 31, 2011 | Southmedic, Inc. Southmedic/Personna Safety Scalpel with Personna Plus Blades, Reorder No. 73-0610, Size #10, General Surgical Use, Sterile, unless package is damaged or opened., Southmedic Inc., 50 Alliance Blvd., Ba Terminated |
GDX | None listed |
| Jul 4, 2006 | Southmedic Inc Vapofils with Stainless Steel Block Ends, Item Number V0507S (Sevofluane). The vapofil is a keyed anesthetic transfer tube that transfers the anesthetic from the bottle to the vaporizer. Terminated |
CAD | K945993 |
| Jul 4, 2006 | Southmedic Inc Vapofils with Stainless Steel Block Ends, Item Number V0507F (Isoflurane). The vapofil is a keyed anesthetic transfer tube that transfers the anesthetic from the bottle to the vaporizer. Terminated |
CAD | K945993 |