Solventum Canada Limited

FDA Device Registration & Listing · Morden Manitoba, CA · Registration 3038988287

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3038988287
FEI Number
3038988287
Entity Name
Solventum Canada Limited
City/State/Country
Morden Manitoba, CA
Establishment Address
400 Route 100, Morden Manitoba R6M 1Z9, CA
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Solventum US LLC (Owner Number: 10091183)
Owner / Operator Contact Address
12930 IH 10 West, San Antonio, TX 78249, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

3M Red Dot Electrodes 3M Electrosurgical Patient Plate 3M Universal Electrosurgical Pad 3M Electrosurgical Patient Plates

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2008-04-11
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-01-22
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-12-07
LDE Stethoscope, Manual Cardiovascular Class 1 870.1875 2003-10-22
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-12-14
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2004-01-28

Official Correspondent

JEFFERY SCHORR

US Agent Details

JEFFERY SCHORR Business: SOLVENTUM US LLC Email: RegulatoryRequests@solventum.com Phone: (210) 2556721

Related Public Records

Same Entity

Solventum US LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3004943440 3M Purification, S. de R.L. de C. V. San Luis Potosi Mexico, MX
3003775292 KCI POLYMEDICS BV PEER Limburg, BE
3036108847 Solventum US LLC Eden Prairie, MN, US
3032763783 Solventum Poland Manufacturing SP. ZO.O Wroclaw Dolnoslaskie, PL
3014209526 KCI NORTH IX (Technical Services Center) San Antonio, TX, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K934333 3M Medical Products Group 3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE 1994-07-07
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18
K222793 C.R. Bard, Inc. WavelinQ™ Generator 2022-10-17
K002257 Tecno Instruments (Pvt.) , Ltd. TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 2000-10-19
K193591 Bowa-Electronics GmbH & Co. KG ARC 400 2020-04-02

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0013-2019 COVIDIEN LLC 1
Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019 COVIDIEN LLC 1
Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019 COVIDIEN LLC 1
Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019 COVIDIEN LLC 1
Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038988287. Last updated year: 2026. Please use registration number 3038988287 when referencing this establishment in official correspondence.
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