SOLVENTUM US LLC (Apodaca)

FDA Device Registration & Listing · Apodaca Nuevo Leon, MX · Registration 3041276890

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
3041276890
FEI Number
3041276890
Entity Name
SOLVENTUM US LLC (Apodaca)
City/State/Country
Apodaca Nuevo Leon, MX
Establishment Address
Industries Parque Industrial Apodaca II, Apodaca Nuevo Leon 66647, MX
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Solventum US LLC (Owner Number: 10091183)
Owner / Operator Contact Address
12930 IH 10 West, San Antonio, TX 78249, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K940707
PMA Number
N/A

All Registered Proprietary Names

3M 3M¿ Ioban¿ 2 3M¿ Steri-Drape¿ Ioban¿ 2 3M 3M 3M(TRADE MARK) BIO 3M 3M

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KGT Drape, Adhesive, Aerosol General, Plastic Surgery Class 1 878.4380 2012-05-18
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2007-12-06
LRO General Surgery Tray General, Plastic Surgery Class 2 878.4370 2011-05-10
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2004-01-28
DWJ System, Thermal Regulating Cardiovascular Class 2 870.5900 2013-01-17
KME Bedding, Disposable, Medical General Hospital Class 1 880.6060 1995-03-02
EYY Drape, Urological, Disposable General, Plastic Surgery Class 2 878.4370 2020-07-07
NAC Dressing, Wound, Hydrophilic General, Plastic Surgery Class 1 878.4018 2004-01-28
KGW Ring (Wound Protector), Drape Retention, Internal General, Plastic Surgery Class 2 878.4370 2020-07-07
IMD Pack, Hot Or Cold, Disposable Physical Medicine Class 1 890.5710 1993-01-21
HMP Pad, Eye General, Plastic Surgery Class 1 878.4440 2025-04-17
PUI Drape, Surgical, Exempt General, Plastic Surgery Class 2 878.4370 2017-08-07
DWJ System, Thermal Regulating Cardiovascular Class 2 870.5900 2021-09-17
GDT Staple, Removable (Skin) General, Plastic Surgery Class 1 878.4760 1995-03-03
IME Pack, Hot Or Cold, Reusable Physical Medicine Class 1 890.5700 2024-07-18
KGY Bag, Intestine General, Plastic Surgery Class 1 878.4100 2004-01-28
DWJ System, Thermal Regulating Cardiovascular Class 2 870.5900 2021-09-17
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2025-09-22

Official Correspondent

JEFFERY SCHORR

US Agent Details

JEFFERY SCHORR Business: SOLVENTUM US LLC Email: RegulatoryRequests@solventum.com Phone: (210) 2556721

Related Public Records

Same Entity

Solventum US LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3004943440 3M Purification, S. de R.L. de C. V. San Luis Potosi Mexico, MX
3003775292 KCI POLYMEDICS BV PEER Limburg, BE
3036108847 Solventum US LLC Eden Prairie, MN, US
3038988287 Solventum Canada Limited Morden Manitoba, CA
3032763783 Solventum Poland Manufacturing SP. ZO.O Wroclaw Dolnoslaskie, PL

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K914369 Deroyal Industries, Inc. QUALTEX MAGNETIC INSTRUMENT DRAPE 1991-12-02
K812809 Abco Dealers, Inc. STERILE ADHERENT DRAPES 1981-11-06
K910084 Biocor Medical, Inc. SURGICAL DRAPE 1991-03-19
K961683 J.J. Skinner, Inc. JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY 1996-05-10
K881936 Iberhospitex, S.A. OPER-FILM-ADHESIVE MEMBRANE 1988-08-31

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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.
Z-0031-2025 Windstone Medical Packaging, Inc. 2
Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0095-2021 Alcon Research, LLC 2
Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.

Similar Registrations

Registration Number Establishment Name Location
3026331889 NINGBO HYSENT MEDICAL TECHNOLOGY CO., LTD Ningbo Zhejiang, CN
3010034780 Smith & Nephew, Inc. Lawrenceville, GA, US
3009420598 Primo Medical Group, Inc W Bridgewater, MA, US
3013863160 HUBEI HENDRY MEDICAL APPLIANCE CO., LTD Xiaogan City Hubei, CN
3009303243 JIANGSU CLASSIC NEW-TYPE MEDICAL PRODUCTS CO., LTD Yancheng Jiangsu, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3041276890. Last updated year: 2026. Please use registration number 3041276890 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.