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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 65 of 70

Device	Model / Reference	Registries	Class	Status
Multi-Allergen Ige Fastscreen V (t1, T3, T5, T7, T10)	K883371	FDA 510(k)	Class II	Active
3M Comply Hydrogen Peroxide Indicator Tape	K183209	FDA 510(k)	Class II	Active
3M Attest Rapid Readout Biological Indicator 1295	K152060	FDA 510(k)	Class II	Active
Neer Ii Total Shoulder System & Prosthesis	K895226	FDA 510(k)	Class II	Active
Bone Stapling Fixation Sys	K840566	FDA 510(k)	Class II	Active
Isolation Bag 3m	K832318	FDA 510(k)	Class I	Active
3m Xp-2000 X-Ray Film Processor	K940558	FDA 510(k)	Class II	Active
Total Ige Fast (tm) Test Package	K873998	FDA 510(k)	Class II	Active
Intravascular Administration Set Model 60040	K891009	FDA 510(k)	Class II	Active
Total/Ige Theophylline Control Sera	K870151	FDA 510(k)	Class I	Active
3m Littmann Electronic Stethoscope, Model 3000	K041934	FDA 510(k)	Class II	Active
Dermatac Drape	K220560	FDA 510(k)	Class II	Active
3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E	K240717	FDA 510(k)	Class II	Active
3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus Chaallenge Pack, 3M Attest Auto-reader, 3M Attest Auto-reader	K173519	FDA 510(k)	Class II	Active
Acsys Prefix Acetabular Cup Prosthesis	K900261	FDA 510(k)	Class II	Active
3m Heat Comfort Portable Self-Heating Pad	K901778	FDA 510(k)	Class I	Active
Scotchbond Dental Adhesive	K813180	FDA 510(k)	Class II	Active
3M Clarity Aligners	K183159	FDA 510(k)	Class II	Active
Kitecko Ultrasound Standoff Pad	K851982	FDA 510(k)	Class II	Active
3m Tegasorb Hydrocolloid Dressing	K982893	FDA 510(k)	Class I	Active
Model 600 Syringe Pump	K891237	FDA 510(k)	Class II	Active
3m Littmann Scope-To Scope Software System	K101834	FDA 510(k)	Class II	Active
3m Frascia Stapling System	K823888	FDA 510(k)	Class I	Active
Tegaderm Transparent Dressing	K812678	FDA 510(k)	U	Active
Ige Fastscreen S6 (f1, F2, F4, F13, F14)	K885065	FDA 510(k)	Class II	Active
Tegapore Wound Contact Material, Product #563x	K890354	FDA 510(k)	Class I	Active
3m Rapidstat Ligating Clip Sys	K842382	FDA 510(k)	Class II	Active
3M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge Pack, 3M Attest Auto-reader, 3M Attest Mini Auto-reader	K213809	FDA 510(k)	Class II	Active
Cdi(tm) 300, 400 & 100, Modification	K915255	FDA 510(k)	Class II	Active
Specific Ige Fast(tm) Test Ii	K863967	FDA 510(k)	Class II	Active
Leinbach Hip Prosthesis	K896257	FDA 510(k)	Class II	Active
Sarns Vent Catheter	K890024	FDA 510(k)	Class II	Active
3m Digital Disk Interface Unit	K920268	FDA 510(k)	Class I	Active
3m Osteotomy Guide	K830360	FDA 510(k)	Class I	Active
3m Model 8241 Ite Hearing Aid	K910759	FDA 510(k)	Class I	Active
Lava Ultimate Cad/Cam Restorative For Cerec Lava Ultimate Cad/Cam Restorative For E4d Lava Ultimate Implant Crown Restor	K122569	FDA 510(k)	Class II	Active
3m Sustel Dental System	K970500	FDA 510(k)	Class II	Active
3m Dent System	K962785	FDA 510(k)	Class II	Active
3m Titanium Alloy Total Hip System 32mm	K800487	FDA 510(k)	Class II	Active
Dhbti-Allergen Ige Fastscreen Iv (g1, G5, G12, G13)	K883273	FDA 510(k)	Class II	Active
Xse	K011167	FDA 510(k)	Class II	Active
Cdi(tm) 2000 Blood Gas Monitoring Syst, Modified	K912030	FDA 510(k)	Class II	Active
Modification To: Attest Rapid Readout Biological Indicator, Mode 1292	K090569	FDA 510(k)	Class II	Active
Silux Plus Light Cured Restorative Material	K872444	FDA 510(k)	Class II	Active
Multi-Allergen Ige Fast Screen Iii D1, E1, G6, M2, T3	K880001	FDA 510(k)	Class II	Active
Memorymate Hearing Aid With Pmc Programmer	K904020	FDA 510(k)	Class I	Active
3m Multi-Allergen Ige Fastscreen(tm) S8	K900244	FDA 510(k)	Class II	Active
Red Dot Monitoring Electrodes #2260/65	K821438	FDA 510(k)	Class II	Active
3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228	K192673	FDA 510(k)	Class II	Active
3m Brand Microvascular Anastomotic Coupler (27xx)	K861985	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.