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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 67 of 70

Device	Model / Reference	Registries	Class	Status
3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H	K173437	FDA 510(k)	Class II	Active
3m Maxi-Driver Ii Electric System	K951118	FDA 510(k)	Class I	Active
3m Littmann Electronic Stethoscope, Model 3200	K083903	FDA 510(k)	Class II	Active
3m Infusion System	K812442	FDA 510(k)	Class II	Active
Steri-Lok Dual Purpose Packaging/8400	K811670	FDA 510(k)	Class II	Active
3m Iv Flow Regulator	K896907	FDA 510(k)	Class II	Active
3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing	K153410	FDA 510(k)	U	Active
3m Steri-Vac Sterilizer/Aerator	K142034	FDA 510(k)	Class II	Active
3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M)	K233814	FDA 510(k)	Class II	Active
3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation	K210605	FDA 510(k)	Class II	Active
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E	K212022	FDA 510(k)	Class II	Active
Multi-Allergen Ige Fast Screen (molds)	K880002	FDA 510(k)	Class II	Active
Scotchprime Ceramic Primer	K853698	FDA 510(k)	Class II	Active
Bateman Upf Ii Hip Prosthesis System	K895120	FDA 510(k)	Class II	Active
3m Cement Remover	K791056	FDA 510(k)	Class I	Active
Modification To: 3m Littmann Electronic Stethoscope, Model 3000	K050159	FDA 510(k)	Class II	Active
3m Microbial Profile System Gram	K791789	FDA 510(k)	Class I	Active
3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad	K200835	FDA 510(k)	U	Active
3m Arthroscopic Surgical System	K855216	FDA 510(k)	Class I	Active
Bird Heated Humidifier 3201	K842523	FDA 510(k)	Class II	Active
Fast Set Vinylpolysiloxane Bite Reg. Material	K932459	FDA 510(k)	Class II	Active
Glenoid Resurfacing Component-3m-10816	K831233	FDA 510(k)	Class II	Active
Curos Jet Disinfecting Cap	K200299	FDA 510(k)	Class II	Active
3M Comply Hydrogen Peroxide Chemical Indicator 1248	K170321	FDA 510(k)	Class II	Active
3m Germicidal Surgical Incise Drape	K801550	FDA 510(k)	Class II	Active
3m Small Volume Infustion (svi) System	K792050	FDA 510(k)	Class II	Active
3M Attest Rapid Readout Biological Indicator, 1295	K211705	FDA 510(k)	Class II	Active
3M Attest Steam Chemical Integrator	K193254	FDA 510(k)	Class II	Active
Orthodontic. Plastic Bracket Primer	K780028	FDA 510(k)	Class II	Active
3m True Definition Scanner	K122467	FDA 510(k)	Class II	Active
Attest Brand Rapid Readout Biological Indicator	K900771	FDA 510(k)	Class II	Active
3m Dental Electronic Anesthesia System	K920119	FDA 510(k)	U	Active
Light Cured Resin Bonded Ceramic	K833797	FDA 510(k)	Class II	Active
T.e.n.s.* Single-Use Electrode	K790850	FDA 510(k)	Class II	Active
3m Xp515 X-Ray Film Processor	K880563	FDA 510(k)	Class II	Active
3M Bair Hugger Temperature Management System (Model 675)	K210603	FDA 510(k)	Class II	Active
3M Comply Hydrogen Peroxide Chemical Indicator 1248	K203458	FDA 510(k)	Class II	Active
3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M	K243501	FDA 510(k)	Class II	Active
3m R.f. Current Suppressor	K801041	FDA 510(k)	Class II	Active
3m Fluid Control System Small Joint Cops Cannula	K912099	FDA 510(k)	Class II	Active
Vitrabond Light Cure Glass Ionomer Liner	K882821	FDA 510(k)	Class I	Active
Sarns Membrane Oxygenator W/Integral Cardio Reserv	K890808	FDA 510(k)	Class II	Active
Filtek One Bulk Fill Restorative	K163207	FDA 510(k)	Class II	Active
Petites Between-Period Protectors	K771547	FDA 510(k)	Class II	Active
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator	K203284	FDA 510(k)	Class II	Active
3m Instant Fit Custom Earmold	K870985	FDA 510(k)	Class I	Active
3m M.g. Material	K981325	FDA 510(k)	Class II	Active
3M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder 10135CH 3M™ Attest™ eBowie-Dick Auto-reader 1190	DEN230068	FDA 510(k)	Class II	Active
Vinyl Polysiloxane Impression Material	K800485	FDA 510(k)	Class II	Active
3m Comply 1228 Gas Plasma Indicator Tape	K020589	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.