Data / Medical devices / Mexico / La Ada de Acuna

La Ada de Acuna: FDA-registered device maker in CIUDAD DE ACUNA Coahuila, Mexico, 69 510(k) clearances

Name: La Ada de Acuna FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

La Ada de Acuna is registered with the FDA (registration 9616096) in CIUDAD DE ACUNA Coahuila, Mexico. It lists 26 device types. The FDA files 69 510(k) clearances under its listings, the newest dated May 18, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9616096
FEI number: 3003807323
Address: KM 4.5 Carreterra Presa La Amistad, CIUDAD DE ACUNA Coahuila, Mexico, 26220
Owner or operator: O&M Halyard, Inc. (10057479)
Roles: Manufacturer
First device listed: April 20, 2018
Registered through: 2026
Brand names listed: 62115 HALYARD* FLUIDSHIELD* Level 2 Procedure Mask, AERO BLUE SURGICAL GOWN, Aero Blue Performance Surgical Gowns, Aero Chrome Breathable Performance Surgical Gown, Aero Chrome Select, Anti-Fog Surgical Mask, Back Table Covers, DISPOSABLE HOT / COLD PACK and more

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Manufacturer	accessdata.fda.gov
Bedding, Disposable, Medical	KME	1	Manufacturer	accessdata.fda.gov
Cap, Surgical	FYF	1	Manufacturer	accessdata.fda.gov
Chamber, Patient Isolation	LGM	2	Manufacturer	accessdata.fda.gov
Cover, Shoe, Operating-Room	FXP	1	Manufacturer	accessdata.fda.gov
Drape, Surgical, Antimicrobial	KKX	2	Manufacturer	accessdata.fda.gov
Drape, Surgical, Exempt	PUI	2	Manufacturer	accessdata.fda.gov
General Surgery Tray	LRO	2	Manufacturer	accessdata.fda.gov
Gown, Examination	FME	1	Manufacturer	accessdata.fda.gov
Gown, Isolation, Surgical	FYC	2	Manufacturer	accessdata.fda.gov
Gown, Surgical	FYA	2	Manufacturer	accessdata.fda.gov
Mask, Surgical	FXX	2	Manufacturer	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Manufacturer	accessdata.fda.gov
Pack, Hot Or Cold, Disposable	IMD	1	Manufacturer	accessdata.fda.gov
Patient Personal Hygiene Kit	NSB	1	Manufacturer	accessdata.fda.gov
Pediatric/Child Facemask	OXZ	2	Manufacturer	accessdata.fda.gov
Respirator, Surgical	MSH	2	Manufacturer	accessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	HOY	1	Manufacturer	accessdata.fda.gov
Shoe And Shoe Cover, Conductive	BWP	1	Manufacturer	accessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	2	Manufacturer	accessdata.fda.gov
Stocking, Medical Support (For General Medical Purposes)	FQL	1	Manufacturer	accessdata.fda.gov
Stretcher, Patient Restraint	NZD	1	Manufacturer	accessdata.fda.gov
Suit, Surgical	FXO	1	Manufacturer	accessdata.fda.gov
System, Thermal Regulating	DWJ	2	Manufacturer	accessdata.fda.gov
Table And Attachments, Operating-Room	BWN	1	Manufacturer	accessdata.fda.gov
Wrap, Sterilization	FRG	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
May 18, 2026	K253454	HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap	FRG	Substantially Equivalent	O&M Halyard, Inc.	accessdata.fda.gov
March 18, 2026	K251967	HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor	FXX	Substantially Equivalent	O&M Halyard, Inc.	accessdata.fda.gov
December 11, 2025	K252941	HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops	FXX	Substantially Equivalent	O&M Halyard, Inc.	accessdata.fda.gov
May 30, 2025	K243010	Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining (48207); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor (48237); Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor (48247); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops (28797); Fluidshield * 3 Fog-Free Proce	FXX	Substantially Equivalent	Owens & Minor (O&M) Halyard, Inc.	accessdata.fda.gov
September 16, 2024	K234050	HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap	FRG	Substantially Equivalent	O&M Halyard, Inc.	accessdata.fda.gov
July 2, 2024	K232824	FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803); FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805)	FXX	Substantially Equivalent	Owens & Minor (O&M) Halyard, Inc.	accessdata.fda.gov
July 1, 2024	K232777	FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798)	FXX	Substantially Equivalent	Owens & Minor (O&M) Halyard, Inc.	accessdata.fda.gov
June 21, 2024	K232807	Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802)	FXX	Substantially Equivalent	Owens & Minor (O&M) Halyard, Inc.	accessdata.fda.gov
June 14, 2024	K232812	Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116)	FXX	Substantially Equivalent	Owens & Minor (O&M) Halyard, Inc.	accessdata.fda.gov
June 7, 2024	K232806	HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388)	FXX	Substantially Equivalent	Owens & Minor (O&M) Halyard, Inc.	accessdata.fda.gov
June 4, 2024	K232820	HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)	FXX	Substantially Equivalent	Owens & Minor (O&M) Halyard, Inc.	accessdata.fda.gov
January 12, 2024	K233022	Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small	MSH	Substantially Equivalent	Owens & Minor (O&M) Halyard, Inc.	accessdata.fda.gov
July 21, 2021	K210688	AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown	FYA	Substantially Equivalent	O&M Halyard, Inc.	accessdata.fda.gov
March 16, 2020	K200522	AERO CHROME* Breathable Performance Surgical Gowns	FYA	Substantially Equivalent	O&M Halyard, Inc.	accessdata.fda.gov
December 13, 2019	K192362	Aero Blue Performance Surgical Gowns	FYA	Substantially Equivalent	O&M Halyard, Inc.	accessdata.fda.gov
October 10, 2019	K192147	Halyard ONE-STEP* Sterilization Wrap	FRG	Substantially Equivalent	Owens & Minor (O&M) Halyard, Inc.	accessdata.fda.gov
March 22, 2019	K181959	HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)	FRG	Substantially Equivalent	Owens & Minor Halyard, Inc.	accessdata.fda.gov
April 21, 2017	K162930	Aero Chrome* Select Breathable Performance Surgical Gowns	FYA	Substantially Equivalent	Halyard Health, Inc.	accessdata.fda.gov
April 13, 2016	K153255	Aero Chrome* Breathable Performance Surgical Gown	FYA	Substantially Equivalent	Halyard Health, Inc.	accessdata.fda.gov
April 3, 2015	K143053	KIMGUARD ONE-STEP Sterilization Wrap	FRG	Substantially Equivalent	Kimberly-Clark Health Care	accessdata.fda.gov
March 24, 2015	K143287	Fluidshield* Surgical Mask with Expanded Chamber	FXX	Substantially Equivalent	Halyard Health, Inc.	accessdata.fda.gov
March 9, 2015	K142782	KIMGUARD ONE-STEP Sterilization Wrap	FRG	Substantially Equivalent	Kimberly-Clark Health Care	accessdata.fda.gov
December 18, 2014	K141712	KIMGUARD ONE STEP STERILIZATION WRAP	FRG	Substantially Equivalent	Halyard Health	accessdata.fda.gov
November 10, 2014	K140963	KIMGUARD SMART-FOLD STERILIZATION WRAP	FRG	Substantially Equivalent	Kimberly-Clark Corp.	accessdata.fda.gov
August 7, 2014	K141612	KIMGUARD ONE-STEP STERILIZATION WRAP	FRG	Substantially Equivalent	Kimberly-Clark Health Care	accessdata.fda.gov
July 28, 2014	K141071	KIMGUARD ONE-STEP STERILIZATION WRAP	FRG	Substantially Equivalent	Kimberly-Clark Health Care	accessdata.fda.gov
June 9, 2014	K140539	AERO BLUE PERFORMANCE SURGICAL GOWN	FYA	Substantially Equivalent	Kimberly-Clark Corporation	accessdata.fda.gov
December 20, 2013	K131879	KC 300 SURGICAL MASK	FXX	Substantially Equivalent	Kimberly-Clark Corp.	accessdata.fda.gov
August 20, 2013	K113806	KIMGUARD ONE STEP STERILIZATION WRAP	FRG	Substantially Equivalent	Kimberly-Clark Health Care	accessdata.fda.gov
June 22, 2012	K112805	KIMGUARD ONE-STEP STERILIZATION WRAP	FRG	Substantially Equivalent	Kimberly-Clark Corp.	accessdata.fda.gov
May 4, 2012	K113340	KIMBERLY-CLARK CHILD'S FACEMASK	OXZ	Substantially Equivalent	Kimberly-Clark	accessdata.fda.gov
January 19, 2012	K112300	KIMGUARD SMART-FOLD* STERILIZATION WRAP	FRG	Substantially Equivalent	Kimberly-Clark Corp.	accessdata.fda.gov
October 20, 2011	K111402	KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL	FXX	Substantially Equivalent	Kimberly-Clark	accessdata.fda.gov
September 23, 2011	K103150	KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK	OXZ	Substantially Equivalent	Kimberly-Clark	accessdata.fda.gov
April 29, 2011	K110455	KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS	FXX	Substantially Equivalent	Kimberly-Clark Corp.	accessdata.fda.gov
November 9, 2010	K102666	KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIM	KKX	Substantially Equivalent	Kimberly-Clark Corp.	accessdata.fda.gov
March 19, 2010	K093115	KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100	FYA	Substantially Equivalent	Kimberly-Clark Corp.	accessdata.fda.gov
November 2, 2009	K092167	KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500, KC600	FRG	Substantially Equivalent	Kimberly-Clark Corp.	accessdata.fda.gov
September 3, 2009	K091685	KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC 500, KC600	FRG	Substantially Equivalent	Kimberly-Clark Corp.	accessdata.fda.gov
August 10, 2009	K091357	MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400	FYA	Substantially Equivalent	Kimberly-Clark Corp.	accessdata.fda.gov
May 1, 2009	K082554	KIMGUARD STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500 AND KC600	FRG	Substantially Equivalent	Kimberly-Clark Corp.	accessdata.fda.gov
March 27, 2009	K082177	KIMGUARD ONE-STEP STERILIZATION WRAP	FRG	Substantially Equivalent	Kimberly-Clark Corp.	accessdata.fda.gov
March 25, 2009	K083234	KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100	KKX	Substantially Equivalent	Kimberly-Clark Corp.	accessdata.fda.gov
September 3, 2008	K080795	ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN	FYA	Substantially Equivalent	Kimberly-Clark Corp.	accessdata.fda.gov
May 2, 2006	K052824	KIMBERLY-CLARK PROCEDURE GOWN	FYA	Substantially Equivalent	Kimberly-Clark Corp.	accessdata.fda.gov
November 12, 2003	K033021	KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT AND ENERGY TRANSFER PADS	DWJ	Substantially Equivalent	Kimberly-Clark Corp.	accessdata.fda.gov
October 26, 2000	K002577	ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT AND PATIENT ENERGY TRANSFER PADS	DWJ	Substantially Equivalent	Medivance, Inc.	accessdata.fda.gov
July 10, 1998	K981393	MICROCOOL SURGICAL GOWN	FYA	Substantially Equivalent	Kimberly-Clark Corp.	accessdata.fda.gov
February 11, 1998	K973827	KIMBERLY-CLARK SELF-SEAL POUCH FOR LOW TEMPERATURE STERILIZATION	KCT	Substantially Equivalent	Kimberly-Clark Corp.	accessdata.fda.gov
December 22, 1997	K974068	PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL	MSH	Substantially Equivalent	Tecnol Medical Products, Inc.	accessdata.fda.gov
May 3, 1994	K932834	TECNOL PCM 2000	FXX	Substantially Equivalent	Tecnol Medical Products, Inc.	accessdata.fda.gov
March 6, 1991	K905865	ANTI-FOR SURGICAL FACE MASK	FXX	Substantially Equivalent	Anago, Inc.	accessdata.fda.gov
March 4, 1991	K905749	SURGICAL FACE MASK	FXX	Substantially Equivalent	Anago, Inc.	accessdata.fda.gov
September 5, 1990	K902546	THE PROTECTOR & HIGH PERFORMANCE SPLASH MASK	FXX	Substantially Equivalent	Anago, Inc.	accessdata.fda.gov
August 10, 1988	K881471	KIMGUARD (REGULAR & HEAVY DUTY) STERILE WRAP	FRG	Substantially Equivalent	Kimberly-Clark Corp.	accessdata.fda.gov
June 23, 1988	K880386	KIMBERLY-CLARK PROTECTIVE SLEEVE	FYA	Substantially Equivalent	Kimberly-Clark Corp.	accessdata.fda.gov
June 23, 1988	K880382	KIMBERLY-CLARK IMPERVIOUS OPEN BACK GOWN	FYA	Substantially Equivalent	Kimberly-Clark Corp.	accessdata.fda.gov
December 2, 1987	K874608	TECNOL FLUID SHIELD SURGICAL MASK	FXX	Substantially Equivalent	Tecnol New Jersey Wound Care, Inc.	accessdata.fda.gov
November 2, 1987	K873785	TECNOL FOG-FREE SURGICAL MASK W/DERMA-TOUCH TAPE	FXX	Substantially Equivalent	Tecnol New Jersey Wound Care, Inc.	accessdata.fda.gov
November 25, 1986	K864116	ANAGO ISOLATION MASK (#80-950)	LGM	Substantially Equivalent	Anago, Inc.	accessdata.fda.gov
August 7, 1986	K862801	SPUNGUARD PLUS SURGICAL DRAPE	KKX	Substantially Equivalent	Kimberly-Clark Corp.	accessdata.fda.gov
May 12, 1986	K861600	SPUNGUARD PLUS SURGICAL GOWN	FYA	Substantially Equivalent	Kimberly-Clark Corp.	accessdata.fda.gov
July 17, 1984	K831148	HIGH FILTRATION ISO-MASK	FXX	Substantially Equivalent	Tecnol New Jersey Wound Care, Inc.	accessdata.fda.gov
June 11, 1984	K842115	SPUNGARD & SURG. DRAPES-GOWNS & PACKS	KKX	Substantially Equivalent	Kimberly-Clark Corp.	accessdata.fda.gov
March 19, 1984	K840229	CONTROL COVER GOWN	FYC	Substantially Equivalent	Kimberly-Clark Corp.	accessdata.fda.gov
July 26, 1983	K832194	SURGICAL FACE MASK-DISPOSABLE	FXX	Substantially Equivalent	Tecnol New Jersey Wound Care, Inc.	accessdata.fda.gov
January 7, 1983	K823078	SPUNGUARD FACE MASK	FXX	Substantially Equivalent	Kimberly-Clark Corp.	accessdata.fda.gov
December 20, 1978	K781682	SURGICAL GOWNS & DRAPES	FYA	Substantially Equivalent	Kimberly-Clark Corp.	accessdata.fda.gov
February 13, 1978	K780169	MASK, SURGICAL	FXX	Substantially Equivalent	Convertors	accessdata.fda.gov

Compare with other makers

Updated May 18, 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.