FDA Registration
Active
🇺🇸 United States
Solventum US LLC
Reg #: 3031841433
·
FEI: 3031841433
·
Expires 2026
Products
79
Proprietary Names
21
Establishment Types
5
Classifications
79
Registration Details
- Registration Name
- Solventum US LLC
- Registration Number
- 3031841433
- FEI Number
- 3031841433
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 12930 IH 10 West
- City
- San Antonio
- State
- TX
- ZIP
- 78249
- Country
- US
Regulatory Submissions
- 510(k) Number
- K241710
Owner / Operator
- Firm Name
- Solventum US LLC
- Operator Number
- 10091183
- Address
- 12930 IH 10 West
- City
- San Antonio
- State
- TX
- Postal Code
- 78249
- Country
- US
- Correspondent
- JEFFERY J SCHORR
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Indicator, Biological Sterilization Process | FRC | Class 2 | General Hospital | No | 2025-05-22 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2021-02-11 |
| Scissors, Collar And Crown | EIR | Class 1 | Dental | No | 2025-02-21 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2025-02-21 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2007-12-05 |
| System, Thermal Regulating | DWJ | Class 2 | Cardiovascular | No | 2021-09-17 |
| Central Venous Catheter Dressing Change Kit | PEZ | Class 2 | General Hospital | No | 2014-12-12 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2007-12-14 |
| Solvent, Adhesive Tape | KOX | Class 1 | General, Plastic Surgery | No | 1994-06-06 |
| Indicator, Physical/Chemical Sterilization Process | JOJ | Class 2 | General Hospital | No | 2022-04-05 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 1978-08-31 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2012-07-12 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2026-05-14 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 1993-01-21 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2007-12-05 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2004-01-28 |
| Tube Impression And Matrix | KCQ | Class 1 | Dental | No | 2025-06-26 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2024-07-18 |
| Phonocardiograph | DQC | Class 1 | Cardiovascular | No | 2004-01-07 |
| Crown, Preformed | ELZ | Class 1 | Dental | No | 2001-08-06 |
| Adhesive, Bracket And Tooth Conditioner, Resin | DYH | Class 2 | Dental | No | 2007-11-27 |
| Applicator, Resin | KXR | Class 1 | Dental | No | 2001-02-26 |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | Class 1 | Dental | No | 2007-12-07 |
| Material, Impression | ELW | Class 2 | Dental | No | 2007-12-06 |
| Wheel, Polishing Agent | EJQ | Class 1 | Dental | No | 1992-06-29 |
| Prism, Fresnel, Ophthalmic | HKT | Class 1 | Ophthalmic | No | 2025-02-12 |
| Bath, Incubators/Water, All | JTQ | Class 1 | Microbiology | No | 1995-03-02 |
| Cabinet, Ethylene-Oxide Gas Aerator | FLI | Class 2 | General Hospital | No | 2007-12-06 |
| Splint, Clavicle | IQJ | Class 1 | Physical Medicine | No | 2021-06-18 |
| Orthosis, Sacroiliac, Soft | IPW | Class 1 | Physical Medicine | No | 2009-02-16 |
| Cap, Device Disinfectant | QBP | Class 2 | General Hospital | No | 2019-04-01 |
| Sealant, Pit And Fissure, And Conditioner | EBC | Class 2 | Dental | No | 2007-12-06 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2009-07-31 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2003-09-26 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2001-08-06 |
| Warmer, Thermal, Infusion Fluid | LGZ | Class 2 | General Hospital | No | 2013-01-17 |
| Stethoscope, Electronic | DQD | Class 2 | Cardiovascular | No | 2007-01-04 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2024-10-29 |
| Floss, Dental | JES | Class 1 | Dental | No | 2008-03-12 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2007-12-06 |
| Drape, Adhesive, Aerosol | KGT | Class 1 | General, Plastic Surgery | No | 2012-05-18 |
| Stethoscope, Manual | LDE | Class 1 | Cardiovascular | No | 2003-10-22 |
| Razor, Surgical | LWK | Class 1 | General, Plastic Surgery | No | 1995-02-13 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 1995-03-02 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2017-08-07 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2019-11-13 |
| Maintainer, Space Preformed, Orthodontic | DYT | Class 1 | Dental | No | 2018-01-08 |
| Varnish, Cavity | LBH | Class 2 | Dental | No | 2008-02-14 |
| Liner, Cavity, Calcium Hydroxide | EJK | Class 2 | Dental | No | 2008-02-14 |
| Agent, Tooth Bonding, Resin | KLE | Class 2 | Dental | No | 2007-11-28 |
| Bag, Intestine | KGY | Class 1 | General, Plastic Surgery | No | 2004-01-28 |
| Disk, Abrasive | EHJ | Class 1 | Dental | No | 2001-06-12 |
| Staple, Removable (Skin) | GDT | Class 1 | General, Plastic Surgery | No | 1995-03-03 |
| Warmer, Blood, Non-Electromagnetic Radiation | BSB | Class 2 | Hematology | No | 2013-01-17 |
| Bandage, Liquid | KMF | Class 1 | General Hospital | No | 2016-09-01 |
| Sterilizer, Ethylene-Oxide Gas | FLF | Class 2 | General Hospital | No | 2015-02-06 |
| A Chemical Vapor Sterilization Multivariable Chemical Indicator | QKM | Class 2 | General Hospital | No | 2022-09-06 |
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 2002-07-11 |
| Thermometer, Clinical Color Change | FQZ | Class 1 | General Hospital | No | 1997-01-13 |
| Guard, Instrument | LXZ | Class 1 | General, Plastic Surgery | No | 2007-12-05 |
| Antimicrobial Drapes | PLY | Class 2 | General, Plastic Surgery | No | 2024-07-10 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2025-07-10 |
| Device, Warming. Blood And Plasma | KZL | Class 2 | Hematology | No | 2013-01-17 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2004-01-28 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2008-04-11 |
| Drape, Urological, Disposable | EYY | Class 2 | General, Plastic Surgery | No | 2020-07-07 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2011-02-17 |
| General Surgery Tray | LRO | Class 2 | General, Plastic Surgery | No | 2011-05-10 |
| Infusor, Pressure, For I.V. Bags | KZD | Class 1 | General Hospital | No | 2025-02-12 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2011-05-26 |
| Powder, Porcelain | EIH | Class 2 | Dental | No | 2011-03-16 |
| Pliers, Operative | EJY | Class 1 | Dental | No | 2001-08-06 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2004-01-28 |
| Pad, Eye | HMP | Class 1 | General, Plastic Surgery | No | 2025-04-17 |
| Dressing Change Tray | OXQ | Class 1 | General Hospital | No | 2015-02-05 |
| Ring (Wound Protector), Drape Retention, Internal | KGW | Class 2 | General, Plastic Surgery | No | 2020-07-07 |
| Media, Electroconductive | GYB | Class 2 | Neurology | No | 2007-12-06 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2004-01-28 |
| Securement Wound Dressing For Reduction Of Infection | SEL | Class U | Unknown | No | 2019-11-21 |
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
CROWN
Attest Rapid Readout 1291
3M¿ Steri-Vac¿ XL Aeration Cabinet
3M Universal Electrosurgical Pad
3M¿ Littmann® Electronic Stethoscope
3M¿ Ioban¿ 2
3M¿ Steri-Drape¿ Ioban¿ 2
3M SURGICAL CLIPPER
3M(TRADE MARK) BIO
Liquid Bandage Drops
3M Electrosurgical Patient Plate
3M Red Dot Electrodes
Defib Pads
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Manufacture Device in the United States for Export Only
Manufacture Medical Device for Another Party (Contract Manufacturer)