La Ada de Acuna

FDA Device Registration & Listing · CIUDAD DE ACUNA Coahuila, MX · Registration 9616096

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9616096
FEI Number
3003807323
Entity Name
La Ada de Acuna
City/State/Country
CIUDAD DE ACUNA Coahuila, MX
Establishment Address
KM 4.5 CARRETERRA PRESA LA, AMISTAD, CIUDAD DE ACUNA Coahuila 26220, MX
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
O&M Halyard, Inc. (Owner Number: 10057479)
Owner / Operator Contact Address
1220 Old Alpharetta Rd, Suite 320, Alpharetta, GA 30005, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

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 and WrapAround Visor (62116) 62115 HALYARD* FLUIDSHIELD* Level 2 Procedure Mask Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115) HALYARD® SEQUENTIAL Sterilization Wrap HALYARD® ONE-STEP® Sterilization Wrap HALYARD® QUICK CHECK® Sterilization Wrap HALYARD® SMART-FOLD® Sterilization Wrap SURGICAL SUIT HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops EYE SHIELD 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) STERILIZATION WRAP Aero Chrome Select Stockinette SURGICAL GOWN SURGICAL MASK FLUIDSHIELD* 2 Procedure Mask with SO SOFT* Earloops FLUIDSHIELD* 2 Fog-Free Procedure Mask with SO SOFT* Earloops, Blue, WrapAround Visor FLUIDSHIELD* 2 Fog-Free Surgical Mask, Blue with Orange Print FLUIDSHIELD* 2 Fog-Free Surgical Mask, Blue with Orange Print, WrapAround Visor FLUIDSHIELD* 2 Procedure Mask with SO SOFT* Earloops, Blue Fluidshield* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Orange HALYARD PROCEDURE GOWN STERILIZATION WRAP HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Blue, WrapAround Visor HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Blue OPERATING ROOM SHOE COVER SURGICAL GOWN GOWN, DRAPE PACKS SURGICAL DRAPE HALYARD SURGICAL GOWN OPERATING ROOM TABLE AND ATTACHMENTS DISPOSABLE HOT / COLD PACK General Surgery Tray STERILIZATION WRAP SURGICAL DRAPE Surgical Packs HALYARD Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops HALYARD Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops, WrapAround Visor HALYARD Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining HALYARD Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor HALYARD Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with Visor HALYARD Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor HALYARD Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor HALYARD Fluidshield * 3 Surgical Mask with SO SOFT* Lining 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, WrapAround Visor Anti-Fog Surgical Mask SURGICAL MASK K823078 SURGICAL GOWN STERILIZATION WRAP HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) STERILIZATION WRAP Aero Blue Performance Surgical Gowns SHOE AND SHOE COVER THERMAL REGULATING SYSTEM HALYARD GOWN PEDIATRIC / CHILD FACEMASK SMART-FOLD Sterilization Wrap STERILIZATION WRAP AERO BLUE SURGICAL GOWN Patient Welcome Pack Hygiene Kit SURGICAL MASK FLUIDSHIELD* 3 Fog-Free Surgical Mask with So Soft* Lining FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops FLUIDSHIELD* 3 Fog-Free Procedure Mask with So Soft* Lining SURGICAL ISOLATION GOWN SURGICAL GOWN Aero Chrome Breathable Performance Surgical Gown PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL STERILIZATION WRAP PATIENT RESTRAINT STERILIZATION WRAP Halyard ONE-STEP Sterilization Wrap STERILIZATION WRAP STERILIZATION WRAP HALYARD* Level 1 Procedure Mask (48388) HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867) PEDIATRIC / CHILD FACEMASK STERILIZATION WRAP DISPOSABLE MEDICAL BEDDING EXAMINATION GOWN THERMAL REGULATING SYSTEM FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805) 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) SURGICAL DRAPE Surgical Packs Surgical Gown

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2024-07-29
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2024-09-26
FXO Suit, Surgical General, Plastic Surgery Class 1 878.4040 2018-05-02
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2025-12-23
HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) Ophthalmic Class 1 886.4750 2018-05-02
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2024-07-29
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2018-05-02
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2021-08-13
FQL Stocking, Medical Support (For General Medical Purposes) General Hospital Class 1 880.5780 2018-05-31
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2018-05-02
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2018-05-02
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2018-05-18
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2018-05-02
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2026-04-07
FXP Cover, Shoe, Operating-Room General, Plastic Surgery Class 1 878.4040 2018-05-02
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2018-05-02
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2018-05-02
BWN Table And Attachments, Operating-Room General, Plastic Surgery Class 1 878.4950 2018-05-02
IMD Pack, Hot Or Cold, Disposable Physical Medicine Class 1 890.5710 2018-05-02
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2023-02-07
LRO General Surgery Tray General, Plastic Surgery Class 2 878.4370 2022-02-15
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2018-06-20
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2018-05-31
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2025-06-27
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2018-04-27
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2022-12-08
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2018-05-02
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2018-05-02
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2018-05-02
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2024-07-29
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2018-05-02
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2019-12-23
BWP Shoe And Shoe Cover, Conductive General, Plastic Surgery Class 1 878.4040 2018-05-02
DWJ System, Thermal Regulating Cardiovascular Class 2 870.5900 2018-05-02
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2018-05-18
OXZ Pediatric/Child Facemask General, Plastic Surgery Class 2 878.4040 2018-05-02
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2023-02-07
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2020-01-07
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2018-05-02
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2018-05-02
NSB Patient Personal Hygiene Kit Dental Class 1 872.6855 2019-12-31
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2023-02-07
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2018-05-02
FYC Gown, Isolation, Surgical General, Plastic Surgery Class 2 878.4040 2018-05-02
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2023-02-01
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2018-05-02
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2020-03-17
MSH Respirator, Surgical General, Plastic Surgery Class 2 878.4040 2018-05-02
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2018-05-02
NZD Stretcher, Patient Restraint General Hospital Class 1 880.6900 2018-05-02
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2018-05-02
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2020-01-09
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2018-06-28
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2018-05-02
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2018-05-02
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2024-07-29
OXZ Pediatric/Child Facemask General, Plastic Surgery Class 2 878.4040 2018-05-02
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2018-05-02
KME Bedding, Disposable, Medical General Hospital Class 1 880.6060 2018-05-02
FME Gown, Examination General Hospital Class 1 880.6265 2018-05-02
DWJ System, Thermal Regulating Cardiovascular Class 2 870.5900 2018-05-02
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2024-07-29
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2018-05-31
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2018-05-18
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2023-02-01

Official Correspondent

Angela Bunn

US Agent Details

Angela Bunn Business: O&M HALYARD, INC. Email: angela.bunn@owens-minor.com Phone: (470) 3647147

Related Public Records

Same Entity

O&M Halyard, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3012143814 Southaven Distribution Center Southaven, MS, US
3016849443 O&M Halyard, Inc. (La Ada de Acuna) Del Rio, TX, US
1054380 Halyard North Carolina, LLC LINWOOD, NC, US
9680646 O&M Halyard Honduras S.A de C.V. VILLANEVA Cortes, HN
3035642068 Honduras Kitting, S.A. Villanueva Cortes, HN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K201622 Guangdong Kingfa Sci. & Tech.Co., Ltd. Medical surgical mask 2020-11-24
K881618 3M Company ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK 1988-05-09
K892118 Paramount Products, Inc. NON-STERILE MASKS AND CAPS 1989-04-20
K914369 Deroyal Industries, Inc. QUALTEX MAGNETIC INSTRUMENT DRAPE 1991-12-02
K812809 Abco Dealers, Inc. STERILE ADHERENT DRAPES 1981-11-06

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0505-2022 Philips North America Llc 1
Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022 Philips North America Llc 1
Infant Heel Warmers w/strap, Reference # 989805603201 1223
Z-0027-2025 Windstone Medical Packaging, Inc. 2
Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0028-2025 Windstone Medical Packaging, Inc. 2
Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0030-2025 Windstone Medical Packaging, Inc. 2
Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616096. Last updated year: 2026. Please use registration number 9616096 when referencing this establishment in official correspondence.
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