Data / Medical devices / United States / Xodus Medical, Inc.

Xodus Medical, Inc.: FDA-registered device maker in New Kensington, PA, United States, 8 510(k) clearances

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

Xodus Medical, Inc. is registered with the FDA (registration 2530138) in New Kensington, PA, United States. It lists 30 device types. The FDA files 8 510(k) clearances under its listings, the newest dated April 16, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2530138
FEI number: 1000221205
Address: 702 Prominence DR., New Kensington, PA, United States, 15068
Owner or operator: XODUS MEDICAL, INC. (9010904)
Roles: Manufacturer, Repackager or relabeler, Specification developer
First device listed: May 31, 2001
Registered through: 2026
Brand names listed: Absorbent and Antifatigue Mats, Advanced Trendelenburg Positioning Kit, Anti-fog with Pad, ArthroSleeve Shoulder Arthroscopy Kit, Asepto Syringe, Basins, Beach Chair Face Protector, Blue Safety Foam Block and more

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Manufacturer, Specification developer	accessdata.fda.gov
Anti Fog Solution And Accessories, Endoscopy	OCT	2	Manufacturer	accessdata.fda.gov
Bandage, Elastic	FQM	1	Specification developer	accessdata.fda.gov
Basin, Emesis	FNY	1	Manufacturer	accessdata.fda.gov
Blade, Scalpel	GES	1	Specification developer	accessdata.fda.gov
Catheter And Tip, Suction	JOL	2	Manufacturer	accessdata.fda.gov
Component, Traction, Non-Invasive	KQZ	1	Manufacturer	accessdata.fda.gov
Container, Liquid Medication, Graduated	KYW	1	Manufacturer	accessdata.fda.gov
Device, Transfer, Patient, Manual	FMR	1	Manufacturer, Specification developer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Fiber, Medical, Absorbent	FRL	1	Manufacturer, Specification developer	accessdata.fda.gov
Gauze/Sponge, Internal, X-Ray Detectable	GDY	1	Specification developer	accessdata.fda.gov
Handle, Scalpel	GDZ	1	Manufacturer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Manufacturer, Specification developer	accessdata.fda.gov
Kit, Surgical Instrument, Disposable	KDD	1	Manufacturer	accessdata.fda.gov
Label Or Tag, Sterile	LYV	1	Manufacturer	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Manufacturer	accessdata.fda.gov
Light, Surgical, Accessories	FTA	2	Manufacturer	accessdata.fda.gov
Marker, Skin	FZZ	1	Manufacturer	accessdata.fda.gov
Needle, Suturing, Disposable	GAB	1	Manufacturer	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Specification developer	accessdata.fda.gov
Operating Room Accessories Table Tray	FWZ	1	Manufacturer	accessdata.fda.gov
Scale, Surgical Sponge	FQA	1	Manufacturer	accessdata.fda.gov
Stretcher, Hand-Carried	FPP	1	Manufacturer	accessdata.fda.gov
Support, Patient Position	CCX	1	Manufacturer, Specification developer	accessdata.fda.gov
Syringe, Irrigating (Non Dental)	KYZ	1	Manufacturer	accessdata.fda.gov
System, Thermal Regulating	DWJ	2	Manufacturer	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Manufacturer	accessdata.fda.gov
Tape, Measuring, Rulers And Calipers	FTY	1	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
April 16, 2026	K260903	Hot Pink Pad Warming System	DWJ	Substantially Equivalent	Xodus Medical, Inc.	accessdata.fda.gov
September 19, 2018	K182080	Scope Antifogging System	GCJ	Substantially Equivalent	Xodus Medical, Inc.	accessdata.fda.gov
November 3, 2010	K102372	OBS DISPOSABLE ELECTROSURGICAL PADS, MONOPOLAR, BIOPOLAR, MODELS GBS-DM, GBS-DB	GEI	Substantially Equivalent	Jiangmen City Xinhui Baisheng Medical Equipment CO	accessdata.fda.gov
August 12, 2008	K081647	ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPS	GEI	Substantially Equivalent	Xodus Medical, Inc.	accessdata.fda.gov
January 9, 2007	K063587	XODUS MEDICAL ANTI-FOG SOLUTION	OCT	Substantially Equivalent	Xodus Medical, Inc.	accessdata.fda.gov
January 19, 2006	K053433	CAUTERY TIP CLEANER, MODEL 30500	GEI	Substantially Equivalent	Xodus Medical, Inc.	accessdata.fda.gov
January 19, 2006	K053321	LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER	FTA	Substantially Equivalent	Xodus Medical, Inc.	accessdata.fda.gov
April 14, 2003	K030362	SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATES	GEI	Substantially Equivalent	Leonhard Lang GmbH	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
September 19, 2019	83819	Class II	Terminated	Electrosurgical Tip Cleaner REF: 138029 Product Usage: electrosurgical accessory	The sterile barrier of some devices may have been affected	accessdata.fda.gov

Compare with other makers

Updated April 16, 2026. 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.