Data / Medical devices / Canada / Southmedic, Inc.

Southmedic, Inc.: FDA-registered device maker in BARRIE Ontario, Canada, 6 510(k) clearances

Name: Southmedic, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Southmedic, Inc. is registered with the FDA (registration 8022032) in BARRIE Ontario, Canada. It lists 28 device types. The FDA files 6 510(k) clearances under its listings, the newest dated November 21, 2023. 6 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Southmedic, Inc.

FDA registration number: 8022032
FEI number: 3001717360
Address: 50 Alliance BLVD., BARRIE Ontario, Canada, L4M 5K3
Owner or operator: SOUTHMEDIC, INC. (8022032)
Roles: Complaint file establishment, Contract manufacturer, Foreign private label distributor, Manufacturer, Repackager or relabeler, Specification developer
First device listed: October 15, 1998
Registered through: 2026
Brand names listed: ABRA Abdominal 3 Row Pack, ABRA Abdominal Closure, ABRA Adhesive Skin Closure, ABRA DTS Button Tails, ABRA DTS Elastomer Retainer, ABRA DTS Silicone Elastomer Cord, ABRA Loop Cannulator, ABRA Surgical Skin Closure and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Cleaning Brushes, For Endoscope	MNL	1	Complaint file establishment, Foreign private label distributor	accessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	2	Manufacturer	accessdata.fda.gov
Apparatus, Autotransfusion	CAC	2	Contract manufacturer	accessdata.fda.gov
Blade, Scalpel	GES	1	Manufacturer	accessdata.fda.gov
Brush, Scrub, Operating-Room	GEC	1	Complaint file establishment, Foreign private label distributor	accessdata.fda.gov
Cannula, Nasal, Oxygen	CAT	1	Manufacturer	accessdata.fda.gov
Cleaner, Ultrasonic, Medical Instrument	FLG	1	Complaint file establishment, Foreign private label distributor, Specification developer	accessdata.fda.gov
Container, Specimen, Sterile	FMH	1	Contract manufacturer	accessdata.fda.gov
Cup, Menstrual	HHE	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Device, Specimen Collection	LIO	1	Contract manufacturer	accessdata.fda.gov
Dna Specimen Collection, Saliva	OYJ	2	Contract manufacturer	accessdata.fda.gov
Endoscopic Bite Block	MNK	1	Manufacturer	accessdata.fda.gov
General Surgery Tray	LRO	2	Manufacturer	accessdata.fda.gov
Handle, Scalpel	GDZ	1	Manufacturer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Manufacturer	accessdata.fda.gov
Laryngoscope, Rigid	CCW	1	Contract manufacturer	accessdata.fda.gov
Ligator, Hemorrhoidal	FHN	2	Contract manufacturer	accessdata.fda.gov
Mask, Oxygen	BYG	1	Manufacturer	accessdata.fda.gov
Nebulizer (Direct Patient Interface)	CAF	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Research Use Only/Clinical Chemistry Devices	OTV	N	Contract manufacturer	accessdata.fda.gov
Research Use Only/Microbiology	OTT	N	Contract manufacturer	accessdata.fda.gov
Retainer, Surgical	GCZ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Retention Device, Suture	KGS	1	Manufacturer	accessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	HOY	1	Manufacturer	accessdata.fda.gov
Stylet, Tracheal Tube	BSR	1	Contract manufacturer	accessdata.fda.gov
Support, Patient Position	CCX	1	Manufacturer	accessdata.fda.gov
Topical Approximation System	MZR	1	Manufacturer	accessdata.fda.gov
Vaporizer, Anesthesia, Non-Heated	CAD	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 21, 2023	K222511	Oxy2Pro	CCK	Substantially Equivalent	Southmedic, Inc.	accessdata.fda.gov
January 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),	CCK	Substantially Equivalent	Southmedic, Inc.	accessdata.fda.gov
January 7, 2011	K101953	SMDIA-1000	CAF	Substantially Equivalent	Southmedic, Inc.	accessdata.fda.gov
September 23, 1997	K971229	CAPNOXYGEN MASK	CCK	Substantially Equivalent	Medsys, Inc.	accessdata.fda.gov
February 22, 1995	K945993	VAPOFIL	CAD	Substantially Equivalent	Southmedic, Inc.	accessdata.fda.gov
September 3, 1976	K760489	NEBULIZER, HANDHELD (T UP-DRAFT)	CAF	Substantially Equivalent	Hudson Oxygen Therapy Sales Co.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
October 27, 2022	91129	Class II	Ongoing	Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO	Upon review of its batch record, Southmedic identified that lot # W92761 was not sent out for sterilization, and was instead transferred directly to distribution where it was sold and distributed to customers as non-sterile product labelled as sterile.	accessdata.fda.gov
May 25, 2021	88103	Class II	Ongoing	OxyMask O2 Adult REF OM-1125-14	Potential for oxygen tubing to disconnect from mask or loosen. Disconnected tubing results in a loss of device function and use of the device could result in inappropriate or a lack of oxygen delivery to the patient.	accessdata.fda.gov
November 6, 2017	80074	Class II	Terminated	Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures for preparation, scraping and/or cutting of tissue.	Scalpels lot contains non-sterile products labeled as sterile.	accessdata.fda.gov
October 17, 2017	78568	Class II	Terminated	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 me	Potential for loose or missing CO2 diffusers which could result in a non-functioning mask.	accessdata.fda.gov
September 3, 2010	56963	Not yet classified	Terminated	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., Barrie, ON., Canada L4	Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile.	accessdata.fda.gov
April 21, 2006	35358	Not yet classified	Terminated	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.	Southmedic has initiated this recall because their Japanese distributor received field reports of leaking vapofils. Leakage may cause non-toxic spills in the hospital environment, distraction of practitioners during conduct of anesthesia and surgery, and may damage certain plastic equipment. Leakage may also expose patients to low concentrations of volatile	accessdata.fda.gov

Compare with other makers

Updated November 21, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.