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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 70 of 70

Device	Model / Reference	Registries	Class	Status
3M Bair Hugger Model 675 Total Temperature Management System	K171373	FDA 510(k)	Class II	Active
Cdi(tm) H/S Cuvette, Modification	K915265	FDA 510(k)	Class II	Active
Scotchbond Light Cured Dental Adhesive W/Fluoride	K861899	FDA 510(k)	Class II	Active
3m Corneal System (corneal Preservation Medium)	K863129	FDA 510(k)	U	Active
Roth-Kennedy Passer	K791960	FDA 510(k)	Class I	Active
Acsys Selftap Acetabular Cup Prosthesis	K900262	FDA 510(k)	Class II	Active
3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing	K171908	FDA 510(k)	U	Active
3m Brand Restorative Z100	K920425	FDA 510(k)	Class II	Active
Mts Femoral Hip System	K903877	FDA 510(k)	Class II	Active
3m Fukuda Type Ring Retractor	K852567	FDA 510(k)	Class I	Active
3M Comply Hydrogen Peroxide Indicator Tape 1228	K150694	FDA 510(k)	Class II	Active
3m Scotchplate 51148 Small Conductive	K823689	FDA 510(k)	Class II	Active
3m Tegasorb Thin Hydrocolloid Dressing	K982892	FDA 510(k)	Class I	Active
3m Dental Electronic Anesthesia (dea) System 8670 Modification	K935082	FDA 510(k)	U	Active
3M™ Attest™ Super Rapid Readout Biological Indicator 1492V; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M	K241710	FDA 510(k)	Class II	Active
3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H	K192550	FDA 510(k)	Class II	Active
Babybird 2 Ventilator	K820132	FDA 510(k)	Class II	Active
3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248	K222508	FDA 510(k)	Class II	Active
Iso-Shield Saliva Absorbers	K771908	FDA 510(k)	Class I	Active
3m Comply Lead Free Process Indicators For Steam	K101528	FDA 510(k)	Class II	Active
3m Tempcare Light Cure Temporary System	K944981	FDA 510(k)	Class II	Active
3M Protemp Cement Temporary Dental Cement	K170330	FDA 510(k)	Class II	Active
FUTURO™ Premium Compression Elbow Sleeve	49007SPEA	EUDAMED	Class I	Active
FUTURO™ Hinged Knee Brace	48579SPEI	EUDAMED	Class I	Active
FUTURO™ Premium Compression Knee Sleeve with Stabilizers	49001SPEA	EUDAMED	Class I	Active
FUTURO™ Premium Compression Knee Sleeve with Stabilizers	49003DABI	EUDAMED	Class I	Active
FUTURO™ Premium Compression Knee Sleeve with Stabilizers	49001DABI	EUDAMED	Class I	Active
FUTURO™ Premium Compression Knee Sleeve with Stabilizers	49000NORD	EUDAMED	Class I	Active
FUTURO™ Plantar Fasciitis Night Support	48507EU1	EUDAMED	Class I	Active
FUTURO™ Plantar Fasciitis Night Support	48507EU2	EUDAMED	Class I	Active
FUTURO™ Premium Compression Knee Sleeve with Stabilizers	49000DABI	EUDAMED	Class I	Active
FUTURO™ Premium Compression Ankle Sleeve	49004SPEA	EUDAMED	Class I	Active
FUTURO™ Premium Compression Knee Sleeve with Stabilizers	49002DABI	EUDAMED	Class I	Active
FUTURO™ Premium Compression Knee Sleeve with Stabilizers	49002NORD	EUDAMED	Class I	Active
FUTURO™ Hinged Knee Brace	48579DABI	EUDAMED	Class I	Active
FUTURO™ Premium Compression Ankle Sleeve	49005SPEA	EUDAMED	Class I	Active
FUTURO™ Therapeutic Arch Support	48510EU2	EUDAMED	Class I	Active
3m Fluoropolymer Contact Lens (flurofocon A)	P870009	FDA PMA	U	Active
Kennedy Lad(tm) Ligament Augmentation Device	P850069	FDA PMA	Class III	Active
FUTURO™ Premium Compression Knee Sleeve with Stabilizers	49004DABI	EUDAMED	Class I	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.