Company
3M Company - Health Care Business
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
39recalls (0 in 12 months)
24recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DRX | Electrode, Electrocardiograph | 6 |
| FRC | Indicator, Biological Sterilization Process | 5 |
| LWK | Razor, Surgical | 4 |
| FLF | Sterilizer, Ethylene-Oxide Gas | 3 |
| KGX | Tape And Bandage, Adhesive | 3 |
| DWJ | System, Thermal Regulating | 2 |
| IQI | Orthosis, Limb Brace | 2 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | 2 |
| EBF | Material, Tooth Shade, Resin | 1 |
| ELW | Material, Impression | 1 |
| ELZ | Crown, Preformed | 1 |
| FLL | Continuous Measurement Thermometer | 1 |
| FMP | Protector, Skin Pressure | 1 |
| FRO | Dressing, Wound, Drug | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
| ITG | Bandage, Cast | 1 |
| KZD | Infusor, Pressure, For I.V. Bags | 1 |
| LBH | Varnish, Cavity | 1 |
| NOC | Splint, Extremity, Non-Inflatable, External, Non-Sterile | 1 |
| NXC | Aligner, Sequential | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2024 | 3M Company - Health Care Business 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 Open, Classified |
NXC | K233257 |
| Oct 9, 2024 | 3M Company - Health Care Business 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R Open, Classified |
FRO | K063458 K080620 +4 |
| Apr 24, 2024 | 3M Company - Health Care Business 3M Durapore Surgical Tape, Catalog Number 1538-118 Open, Classified |
KGX | None listed |
| Apr 3, 2024 | 3M Company - Health Care Business 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, 2 Open, Classified |
KGX | None listed |
| Feb 21, 2024 | 3M Company - Health Care Business 3M Specialty Blade Assembly, REF 9660,70-2011-8491-1, 7100213026, used with used with 3M Surgical Clipper Catalog Number 9661L Open, Classified |
LWK | None listed |
| Feb 21, 2024 | 3M Company - Health Care Business 3M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with used with 3M Surgical Clipper Catalog Number 9661L Open, Classified |
LWK | None listed |
| Sep 26, 2023 | 3M Company - Health Care Business 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482VF; designed to qualify and monitor dynamic-air removal steam sterilization processes Open, Classified |
FRC | K193154 |
| Sep 26, 2023 | 3M Company - Health Care Business 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482V; designed to qualify and monitor dynamic-air removal steam sterilization processes Open, Classified |
FRC | K193154 |
| Sep 26, 2023 | 3M Company - Health Care Business 3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qualify and monitor dynamic-air removal steam sterilization processes Open, Classified |
FRC | K173519 |
| Sep 26, 2023 | 3M Company - Health Care Business 3M Attest Super Rapid Readout Biological Indicator, REF 1492V; used to qualify or
monitor dynamic-air-removal steam sterilization cycles Open, Classified |
FRC | K173437 |
| May 18, 2023 | 3M Company - Health Care Business 3M Attest Steam Chemical Integrators, REF 1243B Open, Classified |
JOJ | K220942 |
| May 18, 2023 | 3M Company - Health Care Business 3M Attest Steam Chemical Integrators, REF 1243A Open, Classified |
JOJ | K220942 |
| Oct 6, 2021 | 3M Company - Health Care Business 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 pouc Terminated |
DRX | None listed |
| Sep 15, 2020 | 3M Company - Health Care Business 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 electrode Terminated |
DRX | K970796 |
| Sep 15, 2020 | 3M Company - Health Care Business 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 electrode Terminated |
DRX | K970796 |
| Sep 15, 2020 | 3M Company - Health Care Business 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 Terminated |
DRX | K970796 |
| Sep 15, 2020 | 3M Company - Health Care Business 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 p Terminated |
DRX | K970796 |
| Sep 15, 2020 | 3M Company - Health Care Business 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 p Terminated |
DRX | K970796 |
| Nov 21, 2019 | 3M Company - Health Care Business 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 Terminated |
KGX | None listed |
| Jan 14, 2019 | 3M Company - Health Care Business 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 Terminated |
LWK | None listed |
| Jul 6, 2018 | 3M Company - Health Care Business 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 Terminated |
LBH | K132109 |
| Feb 2, 2018 | 3M Company - Health Care Business 3M Surgical Clipper Professional 9681 Terminated |
LWK | None listed |
| Jan 31, 2018 | 3M Company - Health Care Business ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7 Terminated |
IQI | None listed |
| Jan 31, 2018 | 3M Company - Health Care Business FUTURO (TM) SPORT, QUICK STRAP ANKLE SUPPORT, REF 47736GEN, UPC 0 51131 19692 6 Terminated |
IQI | None listed |
| Jan 23, 2018 | 3M Company - Health Care Business 3M Bair Hugger(M) Normothermia System, Sterile Full Access Underbody, Model 63700
The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, the temp Terminated |
DWJ | K060865 |
| Jan 23, 2018 | 3M Company - Health Care Business 3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket, REF 63500
The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, th Terminated |
DWJ | K060865 |
| Nov 1, 2017 | 3M Company - Health Care Business ACE(TM) BRAND, ULTRA LITE ANKLE brace: (a) Size Selection Medium, Cat #901014, UPC 051131019984 2; (b) Size Selection Large, Cat #901015, UPC 0 51131019985 9 Terminated |
NOC | None listed |
| Oct 17, 2017 | 3M Company - Health Care Business 3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000) Terminated |
FLL | K120412 |
| May 22, 2017 | 3M Company - Health Care Business 3M Ranger(TM) Pressure Infusor, Model 145, SKU 70200792979
The 3M Ranger Pressure Infusor is a hardware device intended to provide pressure to I.V. solution bags when rapid infusion of liquids is r Terminated |
KZD | None listed |
| Dec 3, 2016 | 3M Company - Health Care Business 3M Universal Electrosurgical Pad, REF 9130 (100 pads / case) and
3M Universal Electrosurgical Pad with Cord, REF 9135-LP (40 pads / case)
Product Usage:
3M Universal Electrosurgical Pads are design Terminated |
GEI | K974279 |
| Jan 22, 2016 | 3M Company - Health Care Business 3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL. Terminated |
FLF | K902036 K941748 |
| Dec 1, 2015 | 3M Company - Health Care Business 3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF Latex Free Catalog #2081, lot number 2018-10AM. Terminated |
FMP | None listed |
| Jul 8, 2015 | 3M Company - Health Care Business Block Versions Used by Dental Offices often referred to as chairside milling:
Lava Ultimate Restorative for CEREC, Compatible with Sirona mill 2912x, 2914x, 3312x, 3314x.
Lava Ultimate Restorati Terminated |
EBF | K110131 K122569 |
| Jul 7, 2014 | 3M Company - Health Care Business 3M Attest Auto-reader. Model numbers 390, 390G,and 490.
These devices incubate the biological indicators (BIs) to determine a positive or negative result for the sterilization cycle. Terminated |
FRC | K103277 K123546 |
| Apr 2, 2014 | 3M Company - Health Care Business 3M" Steri-Vac" Gas Sterilizer/Aerators, Model #'s 4XL,5XL, 8XL
The 3M" Steri-Vac" Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas ster Terminated |
FLF | K812867 K902036 +1 |
| Dec 18, 2013 | 3M Company - Health Care Business 3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular Body VPS, Catalog Number 5315, Impression Material that are intended to reproduce the structure of a patients teeth.
Impres Terminated |
ELW | K000591 |
| Nov 27, 2013 | 3M Company - Health Care Business 3M ESPE, Unitek Stainless Steel Permanent Molar Crowns
Stainless Steel Crowns, are designed to fill the need for long term provisional coverage on adult molars and bicuspids as well as pediatric post Terminated |
ELZ | None listed |
| Sep 18, 2013 | 3M Company - Health Care Business 3M Scotchcast, Wet or Dry Cast Padding, Catalog Numbers WDP2, WDP3, WDP4, and WDP6.
Intended for use in constructing casts for either wet or dry immobilization. Terminated |
ITG | None listed |
| Oct 9, 2012 | 3M Company - Health Care Business 3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL.
3M Steri-Vac Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerato Terminated |
FLF | K902036 K941748 |