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3M COMPANY

United States·US-MF-000014086

Last updated September 17, 2026

What 3M COMPANY makes

3M COMPANY manufactures a range of medical devices including preformed dental crowns, dental composite resins, mechanical external stethoscopes, patient surgical drapes, hypoallergenic skin adhesive tapes, exudate-absorbent dressings, external circulating-air core temperature regulation system pads, and resin dental inlays. They also produce orthopedic supports such as the FUTURO™ Wraparound Ankle Support, FUTURO™ Night Wrist Support, and FUTURO™ Comfort Elbow Support with Pressure Pads.

The company's portfolio includes Class I, Class II, and U devices, which are listed in the EUDAMED and FDA UDI registries. 3M COMPANY is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What medical devices does 3M COMPANY manufacture?

3M COMPANY produces a variety of medical devices including preformed dental crowns, dental composite resins, mechanical external stethoscopes, patient surgical drapes, hypoallergenic skin adhesive tapes, exudate-absorbent dressings, temperature regulation pads, and resin dental inlays. They also manufacture orthopedic supports like the FUTURO™ Wraparound Ankle Support and FUTURO™ Night Wrist Support.

Where is 3M COMPANY based?

3M COMPANY is based in the United States. The company operates from its headquarters located in the US, where it designs, manufactures, and distributes its medical devices to various markets.

Which regulatory registries list 3M COMPANY's devices?

3M COMPANY's medical devices are listed in the EUDAMED and FDA UDI registries. These databases track medical devices to ensure proper identification, tracking, and regulation throughout their lifecycle in the respective markets.

How are 3M COMPANY's devices classified?

3M COMPANY's medical devices are classified as Class I, Class II, and U devices. Class I devices pose the lowest risk, Class II devices require more regulatory controls, and U devices are unclassified. This classification determines the level of regulatory oversight each product receives.

AI-generated from registry data and not verified by a human reviewer.

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 69 of 70

Device	Model / Reference	Registries	Class	Status
Tenzcare Muscle Stimulation Electrodes	K831104	FDA 510(k)	Class II	Active
Em 1149 Optimize Scotchplate Conduc Adhes Disp Ele	K900332	FDA 510(k)	Class II	Active
3m Comply Bowie- Dick Type Lead Free Test Pack	K093199	FDA 510(k)	Class II	Active
Steri-Drape Surgical Drapes	K031287	FDA 510(k)	Class II	Active
Scotchbond Light Cured Dental Adhes	K841550	FDA 510(k)	Class II	Active
3m Upf Proximal Femur Replacement System	K791823	FDA 510(k)	Class II	Active
3m Model 8242 Ite Hearing Aid	K910760	FDA 510(k)	Class I	Active
3M Comply Hydrogen Peroxide Indicator Tape 1228	K203285	FDA 510(k)	Class II	Active
Sarns 9000 Perfusion System W/Alert Only Level	K900815	FDA 510(k)	Class II	Active
Vs22 Hip Prosthesis	K896266	FDA 510(k)	Class II	Active
3M Attest Steam Chemical Integrator Test Pack	K200766	FDA 510(k)	Class II	Active
Filtek Supreme Ultra Flowable Restorative	K100235	FDA 510(k)	Class II	Active
3m Model 8200p Multipro Bte	K953543	FDA 510(k)	Class I	Active
Tenzcare(tm) Snap Electrode 6867	K864973	FDA 510(k)	Class II	Active
3m Orthopedic Casting Tape	K791094	FDA 510(k)	Class I	Active
Prevena Plus 125 Therapy Unit	K223263	FDA 510(k)	Class II	Active
Pmn Volz Curettes	K831367	FDA 510(k)	Class I	Active
Additonal Allergens For Ige Fast (tm) Test	K864104	FDA 510(k)	Class II	Active
3m Scotchplate Ii Dispersive Electrode	K833364	FDA 510(k)	Class II	Active
3m Model 8243 Ite Hearing Aid	K910761	FDA 510(k)	Class I	Active
Standard Administration Sets	K885030	FDA 510(k)	Class II	Active
Inoculum Stdizing Sys., Inocupac	K781097	FDA 510(k)	N/A	Active
3m I-125 Seeds In Absorbable Carrier	K801748	FDA 510(k)	Class II	Active
3m Cdi Blood Parameter Monitoring System 500	K972962	FDA 510(k)	Class II	Active
Scotchbond Brand Multi-Purpose Adhesive System	K920424	FDA 510(k)	Class II	Active
3m Dental Electronic Anesthesia (dea) System 8670	K935304	FDA 510(k)	U	Active
3m Tegaderm Chg Dressing	K063458	FDA 510(k)	U	Active
3M Attest Rapid Readout Biological Indicator, 1295	K210277	FDA 510(k)	Class II	Active
3m Dry Silver Imager	K855043	FDA 510(k)	Class II	Active
Visilux 2 Visible Light Curing Unit	K851459	FDA 510(k)	Class II	Active
Steri-Vac Gas Sterilizer Model 5xl	K902036	FDA 510(k)	Class II	Active
3m Dent Ii System	K981647	FDA 510(k)	Class II	Active
3m Tegaderm Silver	K040890	FDA 510(k)	U	Active
3m Lvr System	K991961	FDA 510(k)	Class II	Active
3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest Auto-reader	K173584	FDA 510(k)	Class II	Active
3m Model 8295	K954067	FDA 510(k)	Class I	Active
Model 480 Infusion Pump	K894320	FDA 510(k)	Class II	Active
3M Comply Hydrogen Peroxide Indicator Tape	K170563	FDA 510(k)	Class II	Active
3m Temporary Crown & Bridge Material	K935041	FDA 510(k)	Class II	Active
Scotchbond 2 Adhesive W/Scotchprep Dentin Primer	K872279	FDA 510(k)	Class II	Active
Hemox-Analyzer	K771253	FDA 510(k)	Class II	Active
Myocare Plus Dual Channel Stimulator	K851046	FDA 510(k)	Class II	Active
Allergen Specific Controls	K870152	FDA 510(k)	Class II	Active
3m Instant Fit Custom Earmold	K895134	FDA 510(k)	Class I	Active
3m Basic Disposable Surgical Gown, 3m Hp Disposable Surgical Gown, 3m Reinforced Disposable Surgical Gown, 3m Disposable	K101468	FDA 510(k)	Class II	Active
3m Tegasorb Hydrocolloid Dressing	K940624	FDA 510(k)	Class I	Active
3m Model 8245 Ite Hearing Aid	K910763	FDA 510(k)	Class I	Active
Tenzcare Stimulator 6890	K891992	FDA 510(k)	Class II	Active
3m Quik Temp Temporization Material	K001114	FDA 510(k)	Class II	Active
3m First Aid Bandage For Minor Wounds	K901777	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.

The 3M Company has 2 recall records, with the earliest initiated on 2025-04-10 and the most recent on 2025-04-22. The statuses recorded are open and classified. The reasons given for the recalls are: a notice was issued to clarify flow rates related to the inlet fluid temperature, and a field action to clarify flow rates and inlet fluid temperatures along with the location of the outlet temperature for Ranger Blood/Fluid Warming High Flow Sets.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

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.