Data / Medical devices / Canada / Ludlow Technical Products Canada, Ltd. (A Division of Cardinal Health LLC)

Ludlow Technical Products Canada, Ltd. (A Division of Cardinal Health LLC): FDA-registered device maker in GANANOQUE Ontario, Canada, 2 510(k) clearances and 1 PMA approval

Name: Ludlow Technical Products Canada, Ltd. (A Division of Cardinal Health LLC) FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Ludlow Technical Products Canada, Ltd. (A Division of Cardinal Health LLC) is registered with the FDA (registration 9681860) in GANANOQUE Ontario, Canada. It lists 14 device types. The FDA files 2 510(k) clearances and 1 PMA approval under its listings, the newest dated August 7, 2020. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 9681860
FEI number: 3003491392
Address: 215 Herbert St., GANANOQUE Ontario, Canada, K7G 2Y7
Owner or operator: Cardinal Health 200, LLC (9028292)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed: August 3, 1995
Registered through: 2027

Devices it lists

Device	Product code	Class	Role	Source
Automated External Defibrillators (Non-Wearable)	MKJ	3	Manufacturer	accessdata.fda.gov
Binder, Abdominal	FSD	1	Manufacturer	accessdata.fda.gov
Board, Arm (With Cover), Sterile	BTX	1	Manufacturer	accessdata.fda.gov
Clamp, Surgical, General & Plastic Surgery	GDJ	1	Repackager or relabeler	accessdata.fda.gov
Electrode, Circular (Spiral), Scalp And Applicator	HGP	2	Manufacturer	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Contract manufacturer	accessdata.fda.gov
Electrode, Electrocardiograph	DRX	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Electrode, Electrocardiograph, Multi-Function	MLN	2	Manufacturer	accessdata.fda.gov
Full-Montage Standard Electroencephalograph	GWQ	2	Contract manufacturer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Manufacturer	accessdata.fda.gov
Pad, Neonatal Eye	FOK	1	Manufacturer	accessdata.fda.gov
Stand, Infusion	FOX	1	Manufacturer	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	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
May 12, 1998	K980857	MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE	MKJ	Substantially Equivalent	Graphic Controls Corp.	accessdata.fda.gov
January 29, 1991	K904745	MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE	HGP	Substantially Equivalent	Graphic Controls Corp.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
August 7, 2020	P190007	Cardinal Health Multifunctional Defibrillation Electrode	MKJ	0	August 7, 2020	accessdata.fda.gov

Compare with other makers

Updated August 7, 2020. 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.