Data / Medical devices / Mexico / Hill-Rom De Mexico S De RL De CV

Hill-Rom De Mexico S De RL De CV: FDA-registered device maker in APODACA Nuevo Leon, Mexico, 3 510(k) clearances

Name: Hill-Rom De Mexico S De RL De CV FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Hill-Rom De Mexico S De RL De CV is registered with the FDA (registration 3006697241) in APODACA Nuevo Leon, Mexico. It lists 19 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 26, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006697241
Address: AVE.DEL TELEFONO No. 200 COL. HUINALA, APODACA Nuevo Leon, Mexico, 66640
Owner or operator: BAXTER HEALTHCARE CORPORATION (1417572)
Roles: Contract manufacturer, Manufacturer
First device listed: June 21, 1991
Registered through: 2026
Brand names listed: ALLEN DISPOSABLES SURG, ALLEN patient positioners, ATB - Modular Attachment for Mizuho OSI System, ATB Modular Attachment for Steris, Accumax, Advance Table [Allen], Advanta2k, Affinity and more

Devices it lists

Device	Product code	Class	Role	Source
Apparatus, Traction, Non-Powered	HST	1	Contract manufacturer	accessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, Non-Sterile	NNW	1	Contract manufacturer	accessdata.fda.gov
Bariatric Bed	OSI	2	Contract manufacturer	accessdata.fda.gov
Bassinet, Hospital	NZG	2	Contract manufacturer	accessdata.fda.gov
Bed, Ac-Powered Adjustable Hospital	FNL	2	Contract manufacturer	accessdata.fda.gov
Bed, Flotation Therapy, Powered	IOQ	2	Contract manufacturer	accessdata.fda.gov
Bedding, Disposable, Medical	KME	1	Contract manufacturer	accessdata.fda.gov
Device, Transfer, Patient, Manual	FMR	1	Contract manufacturer	accessdata.fda.gov
Ear, Nose, And Throat Stereotaxic Instrument	PGW	2	Manufacturer	accessdata.fda.gov
Mattress, Flotation Therapy, Non-Powered	IKY	1	Contract manufacturer	accessdata.fda.gov
Neurological Stereotaxic Instrument	HAW	2	Manufacturer	accessdata.fda.gov
Operating Room Accessories Table Tray	FWZ	1	Contract manufacturer	accessdata.fda.gov
Protector, Skin Pressure	FMP	1	Contract manufacturer	accessdata.fda.gov
Stand, Infusion	FOX	1	Contract manufacturer	accessdata.fda.gov
Stretcher, Wheeled	FPO	2	Contract manufacturer	accessdata.fda.gov
Stretcher, Wheeled, Powered	INK	2	Contract manufacturer	accessdata.fda.gov
Support, Patient Position	CCX	1	Contract manufacturer	accessdata.fda.gov
Table, Obstetric (And Accessories)	KNC	2	Contract manufacturer	accessdata.fda.gov
Table, Operating-Room, Electrical	GDC	1	Contract 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
June 26, 2020	K200723	StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)	PGW	Substantially Equivalent	Medtronic Navigation, Inc.	accessdata.fda.gov
February 18, 2016	K153247	Fusion Compact Navigation System	PGW	Substantially Equivalent	Medtronic Navigation, Inc.	accessdata.fda.gov
June 12, 2000	K001284	STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM	HAW	Substantially Equivalent	Medtronic Surgical Navigation Technologies	accessdata.fda.gov

Compare with other makers

Updated June 26, 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.