ClearanceBrief
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

CodeDeviceRecords
DRXElectrode, Electrocardiograph6
FRCIndicator, Biological Sterilization Process5
LWKRazor, Surgical4
FLFSterilizer, Ethylene-Oxide Gas3
KGXTape And Bandage, Adhesive3
DWJSystem, Thermal Regulating2
IQIOrthosis, Limb Brace2
JOJIndicator, Physical/Chemical Sterilization Process2
EBFMaterial, Tooth Shade, Resin1
ELWMaterial, Impression1
ELZCrown, Preformed1
FLLContinuous Measurement Thermometer1
FMPProtector, Skin Pressure1
FRODressing, Wound, Drug1
GEIElectrosurgical, Cutting & Coagulation & Accessories1
ITGBandage, Cast1
KZDInfusor, Pressure, For I.V. Bags1
LBHVarnish, Cavity1
NOCSplint, Extremity, Non-Inflatable, External, Non-Sterile1
NXCAligner, Sequential1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Dec 23, 20243M 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
NXCK233257
Oct 9, 20243M Company - Health Care Business
3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Open, Classified
FROK063458
K080620 +4
Apr 24, 20243M Company - Health Care Business
3M Durapore Surgical Tape, Catalog Number 1538-118
Open, Classified
KGXNone listed
Apr 3, 20243M 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
KGXNone listed
Feb 21, 20243M 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
LWKNone listed
Feb 21, 20243M 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
LWKNone listed
Sep 26, 20233M 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
FRCK193154
Sep 26, 20233M 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
FRCK193154
Sep 26, 20233M 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
FRCK173519
Sep 26, 20233M 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
FRCK173437
May 18, 20233M Company - Health Care Business
3M Attest Steam Chemical Integrators, REF 1243B
Open, Classified
JOJK220942
May 18, 20233M Company - Health Care Business
3M Attest Steam Chemical Integrators, REF 1243A
Open, Classified
JOJK220942
Oct 6, 20213M 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
DRXNone listed
Sep 15, 20203M 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
DRXK970796
Sep 15, 20203M 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
DRXK970796
Sep 15, 20203M 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
DRXK970796
Sep 15, 20203M 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
DRXK970796
Sep 15, 20203M 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
DRXK970796
Nov 21, 20193M 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
KGXNone listed
Jan 14, 20193M 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
LWKNone listed
Jul 6, 20183M 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
LBHK132109
Feb 2, 20183M Company - Health Care Business
3M Surgical Clipper Professional 9681
Terminated
LWKNone listed
Jan 31, 20183M Company - Health Care Business
ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7
Terminated
IQINone listed
Jan 31, 20183M Company - Health Care Business
FUTURO (TM) SPORT, QUICK STRAP ANKLE SUPPORT, REF 47736GEN, UPC 0 51131 19692 6
Terminated
IQINone listed
Jan 23, 20183M 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
DWJK060865
Jan 23, 20183M 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
DWJK060865
Nov 1, 20173M 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
NOCNone listed
Oct 17, 20173M Company - Health Care Business
3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)
Terminated
FLLK120412
May 22, 20173M 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
KZDNone listed
Dec 3, 20163M 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
GEIK974279
Jan 22, 20163M Company - Health Care Business
3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.
Terminated
FLFK902036
K941748
Dec 1, 20153M 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
FMPNone listed
Jul 8, 20153M 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
EBFK110131
K122569
Jul 7, 20143M 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
FRCK103277
K123546
Apr 2, 20143M 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
FLFK812867
K902036 +1
Dec 18, 20133M 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
ELWK000591
Nov 27, 20133M 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
ELZNone listed
Sep 18, 20133M 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
ITGNone listed
Oct 9, 20123M 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
FLFK902036
K941748
Get alerts for these product codes