FDA Registration
Active
🇺🇸 United States
SOLVENTUM US LLC
Reg #: 3042272797
·
FEI: 3042272797
·
Expires 2026
Products
75
Proprietary Names
17
Establishment Types
4
Classifications
75
Registration Details
- Registration Name
- SOLVENTUM US LLC
- Registration Number
- 3042272797
- FEI Number
- 3042272797
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1750 Yankee Doodle Rd
- City
- Eagan
- State
- MN
- ZIP
- 55121
- Country
- US
Regulatory Submissions
- 510(k) Number
- K120453
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 |
|---|---|---|---|---|---|
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2012-03-29 |
| Warmer, Thermal, Infusion Fluid | LGZ | Class 2 | General Hospital | No | 2013-01-17 |
| Stethoscope, Manual | LDE | Class 1 | Cardiovascular | No | 2003-10-22 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2019-11-13 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2001-08-06 |
| Indicator, Biological Sterilization Process | FRC | Class 2 | General Hospital | No | 2021-07-12 |
| Indicator, Physical/Chemical Sterilization Process | JOJ | Class 2 | General Hospital | No | 2021-07-12 |
| Dressing Change Tray | OXQ | Class 1 | General Hospital | No | 2015-02-05 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2007-12-05 |
| Varnish, Cavity | LBH | Class 2 | Dental | No | 2008-02-14 |
| Liner, Cavity, Calcium Hydroxide | EJK | Class 2 | Dental | No | 2008-02-14 |
| Sealant, Pit And Fissure, And Conditioner | EBC | Class 2 | Dental | No | 2008-02-14 |
| System, Thermal Regulating | DWJ | Class 2 | Cardiovascular | No | 2013-01-17 |
| Securement Wound Dressing For Reduction Of Infection | SEL | Class U | Unknown | No | 2019-11-21 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2011-02-17 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2017-08-07 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2008-04-11 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2007-12-28 |
| Tube Impression And Matrix | KCQ | Class 1 | Dental | No | 2025-06-26 |
| Bandage, Liquid | KMF | Class 1 | General Hospital | No | 2007-12-06 |
| Sterilizer, Ethylene-Oxide Gas | FLF | Class 2 | General Hospital | No | 2015-02-06 |
| Applicator, Resin | KXR | Class 1 | Dental | No | 2001-02-26 |
| Splint, Clavicle | IQJ | Class 1 | Physical Medicine | No | 2021-06-18 |
| Antimicrobial Drapes | PLY | Class 2 | General, Plastic Surgery | No | 2024-07-10 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2024-07-10 |
| A Chemical Vapor Sterilization Multivariable Chemical Indicator | QKM | Class 2 | General Hospital | No | 2022-09-06 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2011-05-26 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 1978-08-31 |
| Razor, Surgical | LWK | Class 1 | General, Plastic Surgery | No | 1995-02-13 |
| Pliers, Operative | EJY | Class 1 | Dental | No | 2001-08-06 |
| Cap, Device Disinfectant | QBP | Class 2 | General Hospital | No | 2019-04-01 |
| Bag, Intestine | KGY | Class 1 | General, Plastic Surgery | No | 2004-01-28 |
| Prism, Fresnel, Ophthalmic | HKT | Class 1 | Ophthalmic | No | 2025-02-12 |
| Drape, Adhesive, Aerosol | KGT | Class 1 | General, Plastic Surgery | No | 2012-05-18 |
| Disk, Abrasive | EHJ | Class 1 | Dental | No | 2001-06-12 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2024-10-29 |
| Media, Electroconductive | GYB | Class 2 | Neurology | No | 2007-12-06 |
| Guard, Instrument | LXZ | Class 1 | General, Plastic Surgery | No | 2007-12-05 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2012-07-12 |
| Cabinet, Ethylene-Oxide Gas Aerator | FLI | Class 2 | General Hospital | No | 2007-12-06 |
| Wheel, Polishing Agent | EJQ | Class 1 | Dental | No | 1992-06-29 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2025-02-21 |
| Bath, Incubators/Water, All | JTQ | Class 1 | Microbiology | No | 1995-03-02 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2004-01-28 |
| Material, Impression | ELW | Class 2 | Dental | No | 2007-12-06 |
| Pad, Eye | HMP | Class 1 | General, Plastic Surgery | No | 2025-04-17 |
| Drape, Urological, Disposable | EYY | Class 2 | General, Plastic Surgery | No | 2020-07-07 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2004-01-28 |
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 2002-07-11 |
| Staple, Removable (Skin) | GDT | Class 1 | General, Plastic Surgery | No | 1995-03-03 |
| Central Venous Catheter Dressing Change Kit | PEZ | Class 2 | General Hospital | No | 2014-12-12 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 1978-08-31 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2015-04-20 |
| Agent, Tooth Bonding, Resin | KLE | Class 2 | Dental | No | 2007-12-06 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2024-07-18 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2013-01-17 |
| Warmer, Blood, Non-Electromagnetic Radiation | BSB | Class 2 | Hematology | No | 2013-01-17 |
| Scissors, Collar And Crown | EIR | Class 1 | Dental | No | 2025-02-21 |
| Ring (Wound Protector), Drape Retention, Internal | KGW | Class 2 | General, Plastic Surgery | No | 2020-07-07 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2003-09-26 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2004-01-28 |
| Thermometer, Clinical Color Change | FQZ | Class 1 | General Hospital | No | 1997-01-13 |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | Class 1 | Dental | No | 2007-12-07 |
| Stethoscope, Electronic | DQD | Class 2 | Cardiovascular | No | 2007-01-04 |
| Adhesive, Bracket And Tooth Conditioner, Resin | DYH | Class 2 | Dental | No | 2024-03-21 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2000-09-07 |
| Phonocardiograph | DQC | Class 1 | Cardiovascular | No | 2004-01-07 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2025-07-10 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2004-01-28 |
| Floss, Dental | JES | Class 1 | Dental | No | 2008-03-12 |
| Crown, Preformed | ELZ | Class 1 | Dental | No | 2001-08-06 |
| Infusor, Pressure, For I.V. Bags | KZD | Class 1 | General Hospital | No | 2025-02-12 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2010-07-15 |
| Powder, Porcelain | EIH | Class 2 | Dental | No | 2011-03-16 |
| Device, Warming. Blood And Plasma | KZL | Class 2 | Hematology | No | 2013-01-17 |
Proprietary Names
3M Red Dot Electrodes
3M Electrosurgical Patient Plates
Liquid Bandage Drops
3M SURGICAL CLIPPER
3M Electrosurgical Patient Plate
3M
Defib Pads
3M Littmann TeleSteth Online Auscultation System
3M¿ Steri-Vac¿ XL Aeration Cabinet
Attest Rapid Readout 1291
3M Universal Electrosurgical Pad
3M¿ Attest¿ Auto-Reader
3M¿ Ioban¿ 2
3M¿ Steri-Drape¿ Ioban¿ 2
3M¿ Littmann® Electronic Stethoscope
PHONOCARDIOGRAPH
CROWN
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)