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3M COMPANY

United States·US-MF-000014086

Last updated September 17, 2026

Information

Country: United States
Address: 2510, Conway Avenue, St.Paul, United States
Website: solventum.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)634-2249
PRRC Contact: Harry Janiski
EUDAMED SRN: US-MF-000014086
FDA FEI Number: 2110898
DUNS Number: 830016148

Catalogue (3490)

Page 68 of 70

Device	Model / Reference	Registries	Class	Status
Sarns Pressure Adjustable Safety System	K893683	FDA 510(k)	Class II	Active
Imprint Vinyl Polysiloxane Impression Material	K882690	FDA 510(k)	Class II	Active
3m Cold/Hot Water Bag And Wrap	K791176	FDA 510(k)	Class I	Active
3m Steri-Strip Antimicrobial Skin Clos	K813265	FDA 510(k)	Class I	Active
Modified Mp-4 Cardioplegia Delivery System W/Condu	K900640	FDA 510(k)	Class II	Active
3m Tegaderm Chg Chlorhexidine Gluconate I.v. Port Dressing	K123679	FDA 510(k)	U	Active
3m Clinpro Sealant	K992326	FDA 510(k)	Class II	Active
3m Curing Light Xl1500	K934746	FDA 510(k)	Class II	Active
3m Model 8233 Hearing Instrument	K943854	FDA 510(k)	Class I	Active
Mms Acetabular Cups	K830361	FDA 510(k)	Class II	Active
3m Esthetic Design System (tints & Masking Agents)	K862590	FDA 510(k)	Class II	Active
3m Proplus System	K963766	FDA 510(k)	Class II	Active
Concise Light Cured White Sealant	K844211	FDA 510(k)	Class II	Active
3m Disposable Skin Stapler	K800535	FDA 510(k)	Class I	Active
Memorymate Model 8270 Ite Hearing Aid	K905483	FDA 510(k)	Class I	Active
Model 80 Hearing Aid Dispensing System	K913245	FDA 510(k)	Class I	Active
3m Liquid Bandage	K053409	FDA 510(k)	Class I	Active
3m Espe Adult Crown	K072733	FDA 510(k)	Class II	Active
3m Volume Ventiator Circuit	K820131	FDA 510(k)	Class I	Active
3m Laser Imager	K843502	FDA 510(k)	Class II	Active
3m Mini-Driver Electric System	K955098	FDA 510(k)	Class I	Active
Memorymate Hearing Aid Model 8200	K880082	FDA 510(k)	Class I	Active
3m Vflex Health Care Particulate Respirator And Surgical Mask	K121069	FDA 510(k)	Class II	Active
3m Littmann Electronic Stethoscope, Model 4100	K051790	FDA 510(k)	Class II	Active
3m Tegaderm Matrix Dressing	K110457	FDA 510(k)	U	Active
Multi-Allergen Ige Fast Screen (environmental)	K874446	FDA 510(k)	Class II	Active
Model 280 Infusion Pump	K894360	FDA 510(k)	Class II	Active
Conclude Composite Luting Cement	K822714	FDA 510(k)	Class II	Active
Avi Model 840 Dual Channel Infusion Pump	K900204	FDA 510(k)	Class II	Active
Sarns Membrane Oxygenator W/Integral Cadio. 16380	K895632	FDA 510(k)	Class II	Active
Tegasorb Ulcer Dressing #90-Xxx	K872298	FDA 510(k)	U	Active
3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228	K212081	FDA 510(k)	Class II	Active
3m Attest(tm) Auto-Reader	K123546	FDA 510(k)	Class II	Active
3M™ Attest™ Steam Chemical Integrators	K191236	FDA 510(k)	Class II	Active
3m Littmann Telesteth Online Ausculation System	K120704	FDA 510(k)	Class II	Active
3m Curing Light Xl 3000	K924812	FDA 510(k)	Class II	Active
Aseptex 1809 Fluid-Resistant Molded Surgical Mask	K881618	FDA 510(k)	Class II	Active
3m Vitrebond Light Cure Glass Ionomer/Base	K962065	FDA 510(k)	Class II	Active
Steri-Vac #400c Gas Sterilizer	K812867	FDA 510(k)	Class II	Active
Concise 2 Small Particle Light Curved	K832834	FDA 510(k)	Class II	Active
Sarns Miniprime Cardioplegia Set W/Conducer(tm)	K897039	FDA 510(k)	Class II	Active
3m Steam Sterilization Indicator	K801057	FDA 510(k)	Class II	Active
3m Autoclave Tapes	K932129	FDA 510(k)	Class II	Active
3m Vitremer Luting Cement	K933139	FDA 510(k)	Class II	Active
3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)	K241542	FDA 510(k)	Class II	Active
Electronic Stethoscope	K771653	FDA 510(k)	Class II	Active
Steri-Tractor Wound Retractor	K870543	FDA 510(k)	Class I	Active
3M Attest Rapid Readout Biological Indicator	K173435	FDA 510(k)	Class II	Active
Glenoid Resurface Component Pmn 3m	K831234	FDA 510(k)	Class II	Active
3m Health Care Particulate Respirator And Surgical Mask, Model 1870	K063023	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

3M Deutschland GmbH (Medical) DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Apr 22, 2025	Z-2231-2025	—	open, classified	Notice was issued to clarify flow rates related to the inlet fluid temperature.
Apr 10, 2025	Z-2483-2025	—	open, classified	Field action to clarify the flow rates and inlet fluid temperatures, along with location of the outlet temperature for Ranger Blood/Fluid Warming High Flow Sets.