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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 66 of 70

Device	Model / Reference	Registries	Class	Status
3M™ Attest™ Hydrogen Peroxide Indicator Tape 1228	K222152	FDA 510(k)	Class II	Active
3M Attest Rapid Readout Biological Indicator	K160546	FDA 510(k)	Class II	Active
Sarns Membrane Oxygenator W/Integral Reser. #9461	K896671	FDA 510(k)	Class II	Active
3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)	K220942	FDA 510(k)	Class II	Active
3M Clarity Aligners	K192119	FDA 510(k)	Class II	Active
Total Knee Prosthesis-Nonconstrained	K771511	FDA 510(k)	Class II	Active
Tegaderm Plus Transparent Dressing #952x	K852750	FDA 510(k)	U	Active
3MTM AttestTM Mini Auto-reader 490M	K200092	FDA 510(k)	Class II	Active
Closed Wound Vacuum Drainage System	K790654	FDA 510(k)	Class I	Active
3M Comply Indicator Tape for Ethylene Oxide (EO) Sterilization	K150477	FDA 510(k)	Class II	Active
3M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M	K242538	FDA 510(k)	Class II	Active
3m Dent System Ii Plus	K973961	FDA 510(k)	Class II	Active
Gilb, Model 8010	K011200	FDA 510(k)	Class II	Active
Precise Ila And Ilan Surgical Staples	K885222	FDA 510(k)	Class II	Active
Low Adsorption Administration Set	K885031	FDA 510(k)	Class II	Active
Model 285 Infusion Pump	K894321	FDA 510(k)	Class II	Active
Single/Multiple Component Metallic Bone Fixation	K860600	FDA 510(k)	Class II	Active
3m Wound Contact Material, Product #563x	K881988	FDA 510(k)	Class I	Active
3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M)	K241959	FDA 510(k)	Class II	Active
3m Littmann	K003723	FDA 510(k)	Class II	Active
Tegasorb(tm) Ulcer Dressing, #90-Xxx	K891288	FDA 510(k)	U	Active
3m Igg4 Fast Test Package	K863794	FDA 510(k)	Class II	Active
Bird Mean Airway Pressure Monitor	K812140	FDA 510(k)	Class II	Active
3m Model 8240 Ite Hearing Aid	K910690	FDA 510(k)	Class I	Active
Vanish Varnish, 5% Sodium Fluoride Varnish, Model 12245, Vanish Varnish, 5% Fluoride Varnish, Model 12247	K090519	FDA 510(k)	Class II	Active
Silux Restorative Material & Enamel Bond	K810595	FDA 510(k)	Class II	Active
Tenzcare Snap Electrode, No. 6865	K863307	FDA 510(k)	Class II	Active
3M Attest Super Rapid 5 Steam-Plus Challenge Pack	K193154	FDA 510(k)	Class II	Active
Tenzcare Dual-Channel Stimulator	K800758	FDA 510(k)	Class II	Active
Sterigage Model 1243ra, 1243rb, 1243re	K101249	FDA 510(k)	Class II	Active
3m Luting Cement - Paste A And Paste B	K902041	FDA 510(k)	Class II	Active
3m Attest Rapid Readout Biological Indicator / 3m Attest Auto-Reader	K140392	FDA 510(k)	Class II	Active
Red Dot Cardiac Sensor System	K896155	FDA 510(k)	Class II	Active
Brush, Applicator	K781098	FDA 510(k)	Class I	Active
3M Comply Hydrogen Peroxide Chemical Indicator	K192937	FDA 510(k)	Class II	Active
3m Tr System	K992489	FDA 510(k)	Class II	Active
Spk Sealant	K091632	FDA 510(k)	Class II	Active
3m Model 1860 Health Care Particulate Respirator Type N95	K955382	FDA 510(k)	Class II	Active
P-10 Posterior Filling Material	K802751	FDA 510(k)	Class I	Active
3m Carpal Tunnel	K881703	FDA 510(k)	Class II	Active
3m Glass Ionomer Liner	K864270	FDA 510(k)	Class II	Active
3m Luting Cement, Paste A And B	K911842	FDA 510(k)	Class II	Active
3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 1355	K220564	FDA 510(k)	Class II	Active
3m Attest(tm) Super Rapid Readout Biological Indicator, 3m Attest(tm) Auto-Reader	K121484	FDA 510(k)	Class II	Active
Second Assistant	K890501	FDA 510(k)	Class I	Active
Intravascular Admini. Set Models 60030 & 60050	K891005	FDA 510(k)	Class II	Active
Ortholux Xt	K930086	FDA 510(k)	Class II	Active
3m Vitremer Tri-Cure Glass Ionomer System	K925032	FDA 510(k)	Class II	Active
3m Attest 293 Auto-Reader, 3m Attest 293g Auto-Reader	K052128	FDA 510(k)	Class II	Active
3m Hi-Strength Med. Tape #1534	K802242	FDA 510(k)	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.