Data / Medical devices / Mexico / SOLVENTUM US LLC (Apodaca)

SOLVENTUM US LLC (Apodaca): FDA-registered device maker in Apodaca Nuevo Leon, Mexico, 5 510(k) clearances

Name: SOLVENTUM US LLC (Apodaca) FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

SOLVENTUM US LLC (Apodaca) is registered with the FDA (registration 3041276890) in Apodaca Nuevo Leon, Mexico. It lists 17 device types. The FDA files 5 510(k) clearances under its listings, the newest dated April 29, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3041276890
Address: Industries Parque Industrial Apodaca II, Apodaca Nuevo Leon, Mexico, 66647
Owner or operator: Solventum US LLC (10091183)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed: January 21, 1993
Registered through: 2026
Brand names listed: 3M, 3M(TRADE MARK) BIO, 3M¿ Ioban¿ 2, 3M¿ Steri-Drape¿ Ioban¿ 2

Devices it lists

Device	Product code	Class	Role	Source
Bag, Intestine	KGY	1	Contract manufacturer	accessdata.fda.gov
Bedding, Disposable, Medical	KME	1	Contract manufacturer	accessdata.fda.gov
Drape, Adhesive, Aerosol	KGT	1	Contract manufacturer	accessdata.fda.gov
Drape, Surgical, Antimicrobial	KKX	2	Manufacturer	accessdata.fda.gov
Drape, Surgical, Exempt	PUI	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Drape, Urological, Disposable	EYY	2	Contract manufacturer	accessdata.fda.gov
Dressing, Wound, Hydrophilic	NAC	1	Repackager or relabeler	accessdata.fda.gov
Dressing, Wound, Occlusive	NAD	1	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Fiber, Medical, Absorbent	FRL	1	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
General Surgery Tray	LRO	2	Repackager or relabeler	accessdata.fda.gov
Mask, Surgical	FXX	2	Manufacturer	accessdata.fda.gov
Pack, Hot Or Cold, Disposable	IMD	1	Repackager or relabeler	accessdata.fda.gov
Pack, Hot Or Cold, Reusable	IME	1	Repackager or relabeler	accessdata.fda.gov
Pad, Eye	HMP	1	Repackager or relabeler	accessdata.fda.gov
Ring (Wound Protector), Drape Retention, Internal	KGW	2	Contract manufacturer	accessdata.fda.gov
Staple, Removable (Skin)	GDT	1	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
System, Thermal Regulating	DWJ	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
April 29, 2021	K210605	3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation	DWJ	Substantially Equivalent	3M Company	accessdata.fda.gov
March 30, 2021	K210603	3M Bair Hugger Temperature Management System (Model 675)	DWJ	Substantially Equivalent	3M Company	accessdata.fda.gov
April 24, 2006	K060865	BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850	DWJ	Substantially Equivalent	Arizant Healthcare, Inc.	accessdata.fda.gov
May 23, 1994	K940707	3M SURGICAL MASK WITH FACE SHEILD	FXX	Substantially Equivalent	3M Company	accessdata.fda.gov
September 17, 1981	K801550	3M GERMICIDAL SURGICAL INCISE DRAPE	KKX	Substantially Equivalent	3M Company	accessdata.fda.gov

Compare with other makers

Updated April 29, 2021. 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.