Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031841433

FEI Number

3031841433

Entity Name

Solventum US LLC

City/State/Country

San Antonio, TX, US

Establishment Address

12930 IH 10 West, San Antonio, TX 78249, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Solventum US LLC (Owner Number: 10091183)

Owner / Operator Contact Address

12930 IH 10 West, San Antonio, TX 78249, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K823689

PMA Number

N/A

All Registered Proprietary Names

3M¿ Attest¿ Auto-Reader 3M Electrosurgical Patient Plates 3M BRAND REMOVER LOTION 3M Remover Lotion 3M WATER DDISPERSIBLE ADHESIVE TAPE 3M Littmann TeleSteth Online Auscultation System 3M PHONOCARDIOGRAPH 3M CROWN Attest Rapid Readout 1291 3M¿ Steri-Vac¿ XL Aeration Cabinet 3M 3M 3M 3M Universal Electrosurgical Pad 3M¿ Littmann® Electronic Stethoscope 3M¿ Ioban¿ 2 3M¿ Steri-Drape¿ Ioban¿ 2 3M 3M SURGICAL CLIPPER 3M 3M(TRADE MARK) BIO 3M Liquid Bandage Drops 3M 3M Electrosurgical Patient Plate 3M Red Dot Electrodes 3M Electrosurgical Patient Plate

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2025-05-22
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2021-02-11
EIR	Scissors, Collar And Crown	Dental	Class 1	872.4565	2025-02-21
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2025-02-21
EMA	Cement, Dental	Dental	Class 2	872.3275	2007-12-05
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2021-09-17
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2018-05-31
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2007-12-05
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2017-12-13
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2007-12-05
PEZ	Central Venous Catheter Dressing Change Kit	General Hospital	Class 2	880.5200	2014-12-12
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-14
KOX	Solvent, Adhesive Tape	General, Plastic Surgery	Class 1	878.4730	1994-06-06
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2022-04-05
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	1978-08-31
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2012-07-12
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	1997-02-20
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2026-05-14
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	1993-01-21
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-12-05
EMA	Cement, Dental	Dental	Class 2	872.3275	2007-12-05
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2004-01-28
KCQ	Tube Impression And Matrix	Dental	Class 1	872.6570	2025-06-26
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2024-07-18
DQC	Phonocardiograph	Cardiovascular	Class 1	870.2390	2004-01-07
ELZ	Crown, Preformed	Dental	Class 1	872.3330	2001-08-06
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2007-11-27
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2015-04-20
KXR	Applicator, Resin	Dental	Class 1	872.3140	2001-02-26
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2007-12-07
ELW	Material, Impression	Dental	Class 2	872.3660	2007-12-06
EJQ	Wheel, Polishing Agent	Dental	Class 1	872.6010	1992-06-29
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2007-12-11
HKT	Prism, Fresnel, Ophthalmic	Ophthalmic	Class 1	886.1655	2025-02-12
JTQ	Bath, Incubators/Water, All	Microbiology	Class 1	866.2540	1995-03-02
FLI	Cabinet, Ethylene-Oxide Gas Aerator	General Hospital	Class 2	880.6100	2007-12-06
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2012-03-29
IQJ	Splint, Clavicle	Physical Medicine	Class 1	890.3490	2021-06-18
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-12-06
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2024-11-19
IPW	Orthosis, Sacroiliac, Soft	Physical Medicine	Class 1	890.3490	2009-02-16
QBP	Cap, Device Disinfectant	General Hospital	Class 2	880.5440	2019-04-01
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2007-12-06
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2007-12-05
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2022-11-15
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2009-07-31
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2003-09-26
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2001-08-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-07
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2013-01-17
DQD	Stethoscope, Electronic	Cardiovascular	Class 2	870.1875	2007-01-04
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2024-10-29
JES	Floss, Dental	Dental	Class 1	872.6390	2008-03-12
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2007-12-06
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2009-05-11
KGT	Drape, Adhesive, Aerosol	General, Plastic Surgery	Class 1	878.4380	2012-05-18
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2003-10-22
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2010-05-14
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-12-06
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2007-12-06
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2022-06-02
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2007-12-06
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2020-06-23
LWK	Razor, Surgical	General, Plastic Surgery	Class 1	878.4800	1995-02-13
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2007-12-05
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	1995-03-02
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-08-07
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2019-11-13
DYT	Maintainer, Space Preformed, Orthodontic	Dental	Class 1	872.5525	2018-01-08
EMA	Cement, Dental	Dental	Class 2	872.3275	2007-12-05
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-02-14
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2008-02-14
EJK	Liner, Cavity, Calcium Hydroxide	Dental	Class 2	872.3250	2008-02-14
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2008-02-14
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-12-06
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2016-12-13
EMA	Cement, Dental	Dental	Class 2	872.3275	2007-12-05
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2007-11-28
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2007-12-06
EMA	Cement, Dental	Dental	Class 2	872.3275	2011-05-18
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2021-09-17
KGY	Bag, Intestine	General, Plastic Surgery	Class 1	878.4100	2004-01-28
EHJ	Disk, Abrasive	Dental	Class 1	872.6010	2001-06-12
GDT	Staple, Removable (Skin)	General, Plastic Surgery	Class 1	878.4760	1995-03-03
BSB	Warmer, Blood, Non-Electromagnetic Radiation	Hematology	Class 2	864.9205	2013-01-17
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2020-04-24
KMF	Bandage, Liquid	General Hospital	Class 1	880.5090	2016-09-01
FLF	Sterilizer, Ethylene-Oxide Gas	General Hospital	Class 2	880.6860	2015-02-06
QKM	A Chemical Vapor Sterilization Multivariable Chemical Indicator	General Hospital	Class 2	880.2800	2022-09-06
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2020-06-16
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2025-07-21
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2010-01-27
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2022-11-15
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2002-07-11
KMF	Bandage, Liquid	General Hospital	Class 1	880.5090	2007-12-07
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2007-12-06
FQZ	Thermometer, Clinical Color Change	General Hospital	Class 1	880.2900	1997-01-13
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2025-07-15
EMA	Cement, Dental	Dental	Class 2	872.3275	2007-12-05
LXZ	Guard, Instrument	General, Plastic Surgery	Class 1	878.4800	2007-12-05
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2020-09-09
ELW	Material, Impression	Dental	Class 2	872.3660	2007-12-06
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2022-09-06
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2013-01-17
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2017-04-05
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-01-22
PLY	Antimicrobial Drapes	General, Plastic Surgery	Class 2	878.4370	2024-07-10
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2024-07-10
QBP	Cap, Device Disinfectant	General Hospital	Class 2	880.5440	2019-04-01
KMF	Bandage, Liquid	General Hospital	Class 1	880.5090	2007-12-06
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2025-07-10
KZL	Device, Warming. Blood And Plasma	Hematology	Class 2	864.9205	2013-01-17
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2004-01-28
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2007-12-05
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2013-01-17
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2013-04-25
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2013-03-26
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2000-09-07
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2008-04-11
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2009-11-24
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-14

Official Correspondent

JEFFERY SCHORR

US Agent Details

No US Agent registered (Local establishment).

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

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K972485	Arent, Fox, Kintner, Plotkin & Kahn	CIMPAT N	1997-09-08
K982895	Sterngold/Implamed	STERNOMEGA COMPOMER CEMENT	1998-10-09
K033068	Voco GmbH	IONOFIL COLOR AC	2003-10-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
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Z-0035-2010	Cincinnati Sub-Zero Products Inc	2	WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold in the U.S.) and #86185-100 V ( not sold in the U.S.). Intended for warming patients before, during and after surgery, and other specialty procedures.
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0027-2007	N/A	2	3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031841433. Last updated year: 2026. Please use registration number 3031841433 when referencing this establishment in official correspondence.