3M Company
Saint Paul, MN, US
3M COMPANY appears in FDA device records in Saint Paul, MN. FDA records list 58 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 63 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
3 namesFDA records resolved to 3M Company carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- 3M Company - Health Care Businessenforcement report, recall
- 3M Company / Medical Divisionrecall
- 3M Health Care, Ltd.510(k), recall
510(k) clearance history
Showing 50 of 58FDA records hold 58 510(k) clearances for 3M Company between 1990 and 2021. The busiest year on record is 1993, with 27. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 2 |
| 1991 | 4 |
| 1992 | 10 |
| 1993 | 27 |
| 1994 | 3 |
| 1995 | 2 |
| 1996 | 1 |
| 2012 | 3 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K210605 | 3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation | DWJ | Substantially Equivalent | |
| K192119 | 3M Clarity Aligners | NXC | Substantially Equivalent | |
| K183159 | 3M Clarity Aligners | NXC | Substantially Equivalent | |
| K170330 | 3M Protemp Cement Temporary Dental Cement | EMA | Substantially Equivalent | |
| K163207 | Filtek One Bulk Fill Restorative | EBF | Substantially Equivalent | |
| K151302 | Clinpro Varnish | LBH | Substantially Equivalent | |
| K123085 | FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOCKINGS; FUTURO (TM) TRAVEL PANTYHOSE | DWL | Substantially Equivalent | |
| K122467 | 3M TRUE DEFINITION SCANNER | NOF | Substantially Equivalent | |
| K122569 | LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D LAVA ULTIMATE IMPLANT CROWN RESTOR | EBF | Substantially Equivalent | |
| K953904 | SARNS 9000 UNIVERSAL ROLLER PUMP | DWB | Substantially Equivalent | |
| K926364 | ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X | FRC | Substantially Equivalent | |
| K941534 | MODULAR VS-22 CEMENTED FEMORAL HIP SYSTEM | KWY | Substantially Equivalent | |
| K941748 | STERI-VAC GAS STERILIZER MODEL 8XL | FLF | Substantially Equivalent | |
| K930681 | 3M PREVENTION FABRIC SURGICAL GOWN #78XX | FYA | Substantially Equivalent | |
| K932307 | 3M MAXI-DRIVER II DBATTERY POWERED SYSTEM | KIJ | Substantially Equivalent | |
| K932422 | 3M TEGADERM HP TRANSPARENT DRESSING | KGX | Substantially Equivalent | |
| K932446 | INJECTION SITE | FPA | Substantially Equivalent | |
| K931968 | CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGEN SATURATIO | DRY | Substantially Equivalent | |
| K933006 | AVI INFUSION PUMPS, ADDITIONAL INTENDED USE | FRN | Substantially Equivalent | |
| K933005 | AVI MODEL 600 SYRINGE PUMP | FRN | Substantially Equivalent | |
| K930312 | 3M RED DOT 2234 RADIOLUCENT MONITORING ELECTRODE | DRX | Substantially Equivalent | |
| K932454 | 3M RED DOT 2330 RESTING EKG ELECTRODE | DRX | Substantially Equivalent | |
| K926059 | 3M MODEL 200RT RATE TAPER INFUSION PUMP | FRW | Substantially Equivalent | |
| K926058 | 3M MODEL 280RT RATE TAPER INFUSION PUMP | FRW | Substantially Equivalent | |
| K930468 | 3M INCONTINENCE BARRIER FILM, PRODUCT SERIES 336X | KMF | Substantially Equivalent | |
| K915363 | SARNS 7850 CENTRIFUGAL PUMP (MODIFIED) | KFM | Substantially Equivalent | |
| K920362 | 3M MODULAR SHOULDER SYSTEM | KWS | Substantially Equivalent | |
| K931604 | 3M MEDICAL DIAGNOSTIC VIDEOCASSETTE | IWZ | Substantially Equivalent | |
| K931605 | 3M MEDICAL DIAGNOSTIC SUPER VHS VIDEOCASSETTE | IWZ | Substantially Equivalent | |
| K924871 | MODEL 880 INFUSION PUMP, MODIFICATION | FRN | Substantially Equivalent | |
| K924872 | MODEL 885 INFUSION PUMP, MODIFICATION | FRN | Substantially Equivalent | |
| K924870 | MODEL 480CI INFUSION PUMP, MODIFICATION | FRN | Substantially Equivalent | |
| K924869 | MODEL 480CM INFUSION PUMP, MODIFICATION | FRN | Substantially Equivalent | |
| K924868 | MODEL 480 INFUSION PUMP, MODIFICATION | FRN | Substantially Equivalent | |
| K924867 | 285CI INFUSION PUMP, MODIFICATION | FRN | Substantially Equivalent | |
| K924866 | MODEL 285CM INFUSION PUMP, MODIFICATION | FRN | Substantially Equivalent | |
| K924865 | MODEL 285 INFUSION PUMP, MODIFICATION | FRN | Substantially Equivalent | |
| K924207 | AVI(TM) MODEL 232 STANDARD IV ADMINISTRATION SET | FPA | Substantially Equivalent | |
| K921925 | MANUAL SURGICAL INSTRUMENTS | GCJ | Substantially Equivalent | |
| K924280 | 3M TEGASORB THIN HYDROCOLLOID DRESSING | KMF | Substantially Equivalent | |
| K923068 | AVI MODEL 3100 INFUSION PUMP | FRN | Substantially Equivalent | |
| K925618 | 3M REMOVER LOTION PRODUCT NUMBER 86XX | KOX | Substantially Equivalent | |
| K924487 | RED DOT 2515 CARDIAC SENSOR SYSTEM | BRX | Substantially Equivalent | |
| K920009 | 3M LITTMANN GRAPHIC DISPLAY SYSTEM | DQD | Substantially Equivalent | |
| K922992 | CONDUCER CARDIOPLEGIA SET SITH MP4 | DWF | Substantially Equivalent | |
| K920794 | BRND SKIN PROTECTION PREP SERIES 33XX | KMF | Substantially Equivalent | |
| K921051 | 3M PRECISE BRAND INTERNAL SURGICAL STAPLES | GDW | Substantially Equivalent | |
| K921073 | AVI MODEL 480CI INFUSION PUMP | FRN | Substantially Equivalent | |
| K921072 | AVI MODEL 470CI INFUSION PUMP | FRN | Substantially Equivalent | |
| K920681 | AVI MODEL 285CI INFUSION PUMP | FRN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2110898 | 2110898 | 3M COMPANY | 2510 Conway Ave., Saint Paul, MN 55144 US | 2026 | and 14 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NXCAligner, Sequential
- EZSAppliance, Colostomy, Disposable
- HRXArthroscope
- FQMBandage, Elastic
- KMFBandage, Liquid
- NECBandage, Liquid, Skin Protectant
- FSDBinder, Abdominal
- FLICabinet, Ethylene-Oxide Gas Aerator
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- EMACement, Dental
- DTPDefoamer, Cardiopulmonary Bypass
- LHDDevice, Fertility Diagnostic, Proceptive
- NACDressing, Wound, Hydrophilic
- NADDressing, Wound, Occlusive
- DRXElectrode, Electrocardiograph
- IWZFilm, Radiographic
- FYAGown, Surgical
- FRCIndicator, Biological Sterilization Process
- KIJInstrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
- ITWJoint, Ankle, External Brace
- ITQJoint, Knee, External Brace
- GCJLaparoscope, General & Plastic Surgery
- FXXMask, Surgical
- EBFMaterial, Tooth Shade, Resin
- DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- IQKOrthosis, Cervical
- IQIOrthosis, Limb Brace
- MRIOrthosis, Truncal/Orthosis, Limb
- DTZOxygenator, Cardiopulmonary Bypass
- IMEPack, Hot Or Cold, Reusable
- HMPPad, Eye
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- DWBPump, Blood, Cardiopulmonary Bypass, Roller Type
- FRNPump, Infusion
- NZJRespirator, N95, For Use By The General Public In Public Health Medical Emergencies
- MSHRespirator, Surgical
- FRWScale, Patient
- DTYSensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
- FPASet, Administration, Intravascular
- ILISling, Arm
- KOXSolvent, Adhesive Tape
- IQJSplint, Clavicle
- ILHSplint, Hand, And Components
- GDWStaple, Implantable
- FLFSterilizer, Ethylene-Oxide Gas
- DQDStethoscope, Electronic
- FQLStocking, Medical Support (For General Medical Purposes)
- DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)
- BRXStool, Anesthesia
- IOYSupport, Arm
- NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
- DWJSystem, Thermal Regulating
- KGXTape And Bandage, Adhesive
- LBHVarnish, Cavity
Recall records
Showing 25 of 63| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2231-2025 | 3M Ranger Irrigation Fluid Warming Set, REF 24750 | Notice was issued to clarify flow rates related to the inlet fluid temperature. | Class II | Open, Classified | |
| Z-2483-2025 | 3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370 | 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. | Class I | Open, Classified | |
| Z-0743-2025 | Clarity Precision Grip Attachments, for use in orthodontic treatment. Part numbers/SKUs: 359-830 359-831 359-832 359-833 359-834 359-835 359-836 359-837 | Attachments may not mate with the tooth as intended in the digital treatment design. | Class II | Open, Classified | |
| Z-0038-2025 | 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R | Contamination with foreign substance matter | Class II | Open, Classified | |
| Z-1633-2024 | 3M Durapore Surgical Tape, Catalog Number 1538-118 | Select lots of the 3M Durapore Surgical Tape, Catalog Number 1538-118, were incorrectly labeled with a shelf life of 5 years, rather than 3 years. | Class II | Open, Classified | |
| Z-1475-2024 | 3M Tube Securement Device, Small, 1.7 IN/PO x 2.4 IN/PO, REF 1500U, Sterile; and 3M Tube Securement Device, Large, 2.2 IN/PO x 3.5 IN/PO, REF 1501U, Sterile. Product is packaged 1 device per pouch, 25 pouches per primary carton, and 4 primary cartons per shipper box. | Manufacturing nonconformities are in some lots of the Tube Securement Device, such as the top film layer may be partially or completely missing and some devices may exhibit the appearance of an incorrect shape due to excess material not being removed from the product liner. | Class II | Open, Classified | |
| Z-1170-2024 | 3M Specialty Blade Assembly, REF 9660,70-2011-8491-1, 7100213026, used with used with 3M Surgical Clipper Catalog Number 9661L | 3M has added the following cautionary statement regarding the use of the product: "Caution - To reduce the risk of burns, which if not avoided may result in minor injury: " Do not use on injured skin. " Do not leave clipper running unused in air without applying to skin for more than 1 minute as blade temperature may exceed 41C (105.8F). " Do not leave the clipper blade applied to the same location on the patient s skin for longer than 1 second as potential injury may occur; continuous motion of the clipper during use is required. Note: If clipper is left running unused in air for 10 minutes without applying to skin, the Model 9690 blade maximum temperature may reach 60C (140F) and the Model 9660 blade maximum temperature may reach 77C (170.6F)." | Class II | Open, Classified | |
| Z-1169-2024 | 3M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with used with 3M Surgical Clipper Catalog Number 9661L | 3M has added the following cautionary statement regarding the use of the product: "Caution - To reduce the risk of burns, which if not avoided may result in minor injury: " Do not use on injured skin. " Do not leave clipper running unused in air without applying to skin for more than 1 minute as blade temperature may exceed 41C (105.8F). " Do not leave the clipper blade applied to the same location on the patient s skin for longer than 1 second as potential injury may occur; continuous motion of the clipper during use is required. Note: If clipper is left running unused in air for 10 minutes without applying to skin, the Model 9690 blade maximum temperature may reach 60C (140F) and the Model 9660 blade maximum temperature may reach 77C (170.6F)." | Class II | Open, Classified | |
| Z-2640-2023 | 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482VF; designed to qualify and monitor dynamic-air removal steam sterilization processes | Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Super Rapid Readout Steam Challenge (1496V) may contain biological indicators with a cap that melts, deforms and/or cracks following a steam sterilization cycle of 132C and 135C. | Class II | Open, Classified | |
| Z-2639-2023 | 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482V; designed to qualify and monitor dynamic-air removal steam sterilization processes | Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Super Rapid Readout Steam Challenge (1496V) may contain biological indicators with a cap that melts, deforms and/or cracks following a steam sterilization cycle of 132C and 135C. | Class II | Open, Classified | |
| Z-2638-2023 | 3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qualify and monitor dynamic-air removal steam sterilization processes | Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Super Rapid Readout Steam Challenge (1496V) may contain biological indicators with a cap that melts, deforms and/or cracks following a steam sterilization cycle of 132C and 135C. | Class II | Open, Classified | |
| Z-2637-2023 | 3M Attest Super Rapid Readout Biological Indicator, REF 1492V; used to qualify or monitor dynamic-air-removal steam sterilization cycles | Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Super Rapid Readout Steam Challenge (1496V) may contain biological indicators with a cap that melts, deforms and/or cracks following a steam sterilization cycle of 132C and 135C. | Class II | Open, Classified | |
| Z-1610-2023 | 3M Attest Steam Chemical Integrators, REF 1243B | 3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023 have an increased potential to leak ink during a sterilization cycle. | Class II | Open, Classified | |
| Z-1609-2023 | 3M Attest Steam Chemical Integrators, REF 1243A | 3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023 have an increased potential to leak ink during a sterilization cycle. | Class II | Open, Classified | |
| Z-0188-2022 | 3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape, Catalog No. 2244, (3M ID (SKU): 70-2011-8506-6, SAP ID: 7100212989), packaged 10 electrodes per card, 5 cards per pouch, 20 pouches per shipper box, 1,000 electrodes total per shipper box. The 3M Red Dot Radiolucent Monitoring Electrode with Foam Tape 2244 is intended to be used by healthcare professionals for ECG monitoring. This electrode is disposable, intended for single use, and has been tested for up to 3 days wear. | Potential for breakage of the ECG electrode carbon stud from the eyelet. | Class II | Terminated | |
| Z-0423-2021 | 3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 50 electrodes per pouch; 20 pouches per shipper box (1000 electrodes total). | Corrosion could cause performance failures in the product. | Class II | Terminated | |
| Z-0422-2021 | 3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 50 electrodes per pouch; 20 pouches per shipper box (1000 electrodes total). | Corrosion could cause performance failures in the product. | Class II | Terminated | |
| Z-0421-2021 | 3M Red Dot Monitoring Electrode with 4mm Adapter - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 10 electrodes per card; 4 cards per pouch; 20 pouches per shipper box (800 electrodes total). | Corrosion could cause performance failures in the product. | Class II | Terminated | |
| Z-0420-2021 | Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 3 electrodes per card; 1 card per pouch; 200 pouches per shipper box (600 electrodes total). | Corrosion could cause performance failures in the product. | Class II | Terminated | |
| Z-0419-2021 | Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 5 electrodes per card; 1 card per pouch; 200 pouches per shipper box (1000 electrodes total). | Corrosion could cause performance failures in the product. | Class II | Terminated | |
| Z-0719-2020 | 3M Durapore Advanced, Surgical Tape, Model Numbers: 1590-0, 1590-1, 1590-2, 1590-3, 1591-0, 1591-1, 1591-2, 1591-3, 1590S-1, 1590S-2, 1590B-118, 1590B-136 | While the product meets all safety and efficacy criteria, long term exposure of 3M Durapore Advanced Surgical Tape to continuous high moisture clinical applications has not fully met all of 3M s performance expectations. This use environment may cause tape bond failure, leading the tape to not perform as intended. Further, the tape fibers may fray which could be accidentally ingested or aspirated. | Class II | Terminated | |
| Z-0791-2019 | 3M(TM) Surgical Clipper by Remington(R) REF 9602 The 3M Surgical Clipper Classic, 9602, is intended to remove body hair and head hair from patients in preparation for any medical procedure requiring hair removal. | 3M has recently received reports involving the 3MTM Surgical Clipper by Remington, Model 9602, overheating in mobile/field EMS situations while charging from a modified sine wave power inverter. | Class II | Terminated | |
| Z-0368-2019 | 3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, Rx Only, single use. 200 pack, with each package containing 1 0.40 ml varnish and 1 applicator brush. Product is applied to tooth surfaces for sealing dentinal tubules and treatment of hypersensitive teeth. | Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product. | Class II | Terminated | |
| Z-0777-2018 | 3M Surgical Clipper Professional 9681 | Failure to follow proper charging practices can result in lithium-ion battery degradation, characterized by excessive heat during operation or failure to properly charge. In rare circumstances, battery degradation has been associated with battery venting, which is a rapid release of battery energy. | Class II | Terminated | |
| Z-0946-2018 | ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7 | 3M discovered that the Futuro" Quick Strap Ankle Brace (Cat. #47736EN) and ACE" Brand Deluxe Ankle brace (Cat. #207736) do not have the correct labeling. The products contain natural latex rubber, but do not include the appropriate caution statement. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain