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Data / Medical devices / United States / Solventum Us LLC

Solventum Us LLC: FDA-registered device maker in Eagan, MN, United States, 97 510(k) clearances

Solventum Us LLC is registered with the FDA (registration 3042272797) in Eagan, MN, United States. It lists 75 device types. The FDA files 97 510(k) clearances under its listings, the newest dated November 25, 2024. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Solventum Us LLC
FDA registration number
3042272797
Address
1750 Yankee Doodle Rd, Eagan, MN, United States, 55121
Owner or operator
Solventum US LLC (10091183)
Roles
Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
First device listed
August 31, 1978
Registered through
2026
Brand names listed
3M, 3M Electrosurgical Patient Plate, 3M Electrosurgical Patient Plates, 3M Littmann TeleSteth Online Auscultation System, 3M Red Dot Electrodes, 3M SURGICAL CLIPPER, 3M Universal Electrosurgical Pad, 3M¿ Attest¿ Auto-Reader and more

Devices it lists

DeviceProduct codeClassRoleSource
A Chemical Vapor Sterilization Multivariable Chemical IndicatorQKM2Specification developeraccessdata.fda.gov
Accessories, Implant, Dental, EndosseousNDP1Complaint file establishment, Specification developeraccessdata.fda.gov
Accessories, Retractor, DentalEIF1Complaint file establishment, Specification developeraccessdata.fda.gov
Adhesive, Bracket And Tooth Conditioner, ResinDYH2Manufactureraccessdata.fda.gov
Agent, Tooth Bonding, ResinKLE2Complaint file establishment, Specification developeraccessdata.fda.gov
Antimicrobial DrapesPLY2Specification developeraccessdata.fda.gov
Applicator, ResinKXR1Complaint file establishment, Specification developeraccessdata.fda.gov
Bag, IntestineKGY1Specification developeraccessdata.fda.gov
Bandage, CastITG1Specification developeraccessdata.fda.gov
Bandage, ElasticFQM1Specification developeraccessdata.fda.gov
Bandage, LiquidKMF1Specification developeraccessdata.fda.gov
Bath, Incubators/Water, AllJTQ1Specification developeraccessdata.fda.gov
Cabinet, Ethylene-Oxide Gas AeratorFLI2Specification developeraccessdata.fda.gov
Cap, Device DisinfectantQBP2Specification developeraccessdata.fda.gov
Cement, DentalEMA2Complaint file establishment, Specification developeraccessdata.fda.gov
Central Venous Catheter Dressing Change KitPEZ2Complaint file establishment, Specification developeraccessdata.fda.gov
Continuous Measurement ThermometerFLL2Specification developeraccessdata.fda.gov
Crown And Bridge, Temporary, ResinEBG2Complaint file establishment, Specification developeraccessdata.fda.gov
Crown, PreformedELZ1Complaint file establishment, Specification developeraccessdata.fda.gov
Device, Intravascular Catheter SecurementKMK1Complaint file establishment, Specification developeraccessdata.fda.gov
Digital Physical/Chemical Sterilization Process SensorSBE2Specification developeraccessdata.fda.gov
Disk, AbrasiveEHJ1Complaint file establishment, Specification developeraccessdata.fda.gov
Drape, Adhesive, AerosolKGT1Specification developeraccessdata.fda.gov
Drape, Surgical, AntimicrobialKKX2Complaint file establishment, Specification developeraccessdata.fda.gov
Drape, Surgical, ExemptPUI2Specification developeraccessdata.fda.gov
Drape, Urological, DisposableEYY2Specification developeraccessdata.fda.gov
Dressing Change TrayOXQ1Specification developeraccessdata.fda.gov
Dressing, Wound, DrugFROUComplaint file establishment, Specification developeraccessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or BiologicNAE1Specification developeraccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Specification developeraccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Specification developeraccessdata.fda.gov
Electrode, ElectrocardiographDRX2Specification developeraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Specification developeraccessdata.fda.gov
Fiber, Medical, AbsorbentFRL1Specification developeraccessdata.fda.gov
Floss, DentalJES1Complaint file establishment, Specification developeraccessdata.fda.gov
Guard, InstrumentLXZ1Complaint file establishment, Specification developeraccessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, DentalEGS1Complaint file establishment, Specification developeraccessdata.fda.gov
Implant, Endosseous, Root-FormDZE2Specification developeraccessdata.fda.gov
Indicator, Biological Sterilization ProcessFRC2Specification developeraccessdata.fda.gov
Indicator, Physical/Chemical Sterilization ProcessJOJ2Complaint file establishment, Specification developeraccessdata.fda.gov
Infusor, Pressure, For I.V. BagsKZD1Specification developeraccessdata.fda.gov
Instruments, Dental HandDZN1Complaint file establishment, Specification developeraccessdata.fda.gov
Liner, Cavity, Calcium HydroxideEJK2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Mask, SurgicalFXX2Specification developeraccessdata.fda.gov
Material, ImpressionELW2Complaint file establishment, Specification developeraccessdata.fda.gov
Material, Tooth Shade, ResinEBF2Complaint file establishment, Specification developeraccessdata.fda.gov
Media, ElectroconductiveGYB2Specification developeraccessdata.fda.gov
Pack, Hot Or Cold, ReusableIME1Specification developeraccessdata.fda.gov
Pad, EyeHMP1Specification developeraccessdata.fda.gov
PhonocardiographDQC1Specification developeraccessdata.fda.gov
Pliers, OperativeEJY1Complaint file establishment, Specification developeraccessdata.fda.gov
Powder, PorcelainEIH2Complaint file establishment, Specification developeraccessdata.fda.gov
Prism, Fresnel, OphthalmicHKT1Specification developeraccessdata.fda.gov
Protector, Skin PressureFMP1Specification developeraccessdata.fda.gov
Razor, SurgicalLWK1Specification developeraccessdata.fda.gov
Ring (Wound Protector), Drape Retention, InternalKGW2Specification developeraccessdata.fda.gov
Scissors, Collar And CrownEIR1Complaint file establishment, Specification developeraccessdata.fda.gov
Sealant, Pit And Fissure, And ConditionerEBC2Complaint file establishment, Specification developeraccessdata.fda.gov
Securement Wound Dressing For Reduction Of InfectionSELUComplaint file establishment, Specification developeraccessdata.fda.gov
Splint, ClavicleIQJ1Specification developeraccessdata.fda.gov
Staple, Removable (Skin)GDT1Specification developeraccessdata.fda.gov
Sterilizer, Ethylene-Oxide GasFLF2Specification developeraccessdata.fda.gov
Stethoscope, ElectronicDQD2Specification developeraccessdata.fda.gov
Stethoscope, ManualLDE1Complaint file establishment, Specification developeraccessdata.fda.gov
Syringe, Restorative And Impression MaterialEID1Complaint file establishment, Specification developeraccessdata.fda.gov
System, Thermal RegulatingDWJ2Specification developeraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Specification developeraccessdata.fda.gov
Thermometer, Clinical Color ChangeFQZ1Specification developeraccessdata.fda.gov
Transmitters And Receivers, Physiological Signal, RadiofrequencyDRG2Specification developeraccessdata.fda.gov
Tray, Impression, PreformedEHY1Complaint file establishment, Contract manufacturer, Specification developeraccessdata.fda.gov
Tube Impression And MatrixKCQ1Complaint file establishment, Specification developeraccessdata.fda.gov
Varnish, CavityLBH2Complaint file establishment, Specification developeraccessdata.fda.gov
Warmer, Blood, Non-Electromagnetic RadiationBSB2Specification developeraccessdata.fda.gov
Warmer, Thermal, Infusion FluidLGZ2Specification developeraccessdata.fda.gov
Wheel, Polishing AgentEJQ1Complaint file establishment, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 25, 2024K2425383M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490MFRCSubstantially Equivalent3M Companyaccessdata.fda.gov
October 18, 2024K2419593M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M)FRCSubstantially Equivalent3M Companyaccessdata.fda.gov
September 12, 2024K2417103M™ Attest™ Super Rapid Readout Biological Indicator 1492V; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490MFRCSubstantially Equivalent3M Companyaccessdata.fda.gov
June 27, 2024K2415423M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)FRCSubstantially Equivalent3M Companyaccessdata.fda.gov
May 21, 2024DEN2300683M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder 10135CH 3M™ Attest™ eBowie-Dick Auto-reader 1190SBEUnknown3M Companyaccessdata.fda.gov
December 22, 2023K2340433M™ Transbond™ Orthodontic AdhesiveDYHSubstantially Equivalent3M Unitek Orthodontic Productsaccessdata.fda.gov
May 18, 2023K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)KKXSubstantially Equivalent3M Companyaccessdata.fda.gov
May 10, 2023K2313383M™ Clinpro™ Clear 2.1% Sodium Fluoride TreatmentLBHSubstantially Equivalent3M Espe Dental Productsaccessdata.fda.gov
February 6, 2023K2302703M™ VitCal Liner/BaseEJKSubstantially Equivalent3M Espe Dental Productsaccessdata.fda.gov
September 23, 2022K2221523M™ Attest™ Hydrogen Peroxide Indicator Tape 1228JOJSubstantially Equivalent3M Companyaccessdata.fda.gov
June 28, 2022K2117053M Attest Rapid Readout Biological Indicator, 1295FRCSubstantially Equivalent3M Companyaccessdata.fda.gov
June 24, 2022K2209423M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)JOJSubstantially Equivalent3M Companyaccessdata.fda.gov
June 13, 2022K2216953M Filtek Supreme Flowable RestorativeEBFSubstantially Equivalent3M Company Espe Dental Productsaccessdata.fda.gov
May 23, 2022K2205643M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 1355JOJSubstantially Equivalent3M Companyaccessdata.fda.gov
April 20, 2022K2120223M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348EQKMSubstantially Equivalent3M Companyaccessdata.fda.gov
September 5, 2021K2120813M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228JOJSubstantially Equivalent3M Companyaccessdata.fda.gov
April 29, 2021K2106053M Bair Hugger Universal Warming Gown made with Thinsulate InsulationDWJSubstantially Equivalent3M Companyaccessdata.fda.gov
March 30, 2021K2106033M Bair Hugger Temperature Management System (Model 675)DWJSubstantially Equivalent3M Companyaccessdata.fda.gov
December 11, 2020K2034583M Comply Hydrogen Peroxide Chemical Indicator 1248JOJSubstantially Equivalent3M Companyaccessdata.fda.gov
October 29, 2020K200299Curos Jet Disinfecting CapQBPSubstantially Equivalent3M Companyaccessdata.fda.gov
September 4, 2020K2008353M Tegaderm CHG Chlorhexidine Gluconate Gel PadFROSubstantially Equivalent3M Companyaccessdata.fda.gov
July 2, 2020K2007663M Attest Steam Chemical Integrator Test PackFRCSubstantially Equivalent3M Companyaccessdata.fda.gov
June 1, 2020K2005363MTM AttestTM Rapid 5 Steam-Plus Test PackFRCSubstantially Equivalent3M Complanyaccessdata.fda.gov
April 15, 2020K2000923MTM AttestTM Mini Auto-reader 490MFRCSubstantially Equivalent3Maccessdata.fda.gov
February 7, 2020K1931543M Attest Super Rapid 5 Steam-Plus Challenge PackFRCSubstantially Equivalent3M Companyaccessdata.fda.gov
September 11, 2019K1913553M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure MaskFXXSubstantially Equivalent3M Healthcareaccessdata.fda.gov
January 2, 2019K1834763M Filtek Universal RestorativeEBFSubstantially Equivalent3M Espe Dental Productsaccessdata.fda.gov
July 31, 2018K1808743M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face ShieldFXXSubstantially Equivalent3M Healthcareaccessdata.fda.gov
April 23, 2018K1735193M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus Chaallenge Pack, 3M Attest Auto-reader, 3M Attest Auto-readerFRCSubstantially Equivalent3M Companyaccessdata.fda.gov
January 22, 2018K1735843M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest Auto-readerFRCSubstantially Equivalent3M Companyaccessdata.fda.gov
November 21, 2017K1707543M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement DressingFROSubstantially Equivalent3M Company, 3M Healthcareaccessdata.fda.gov
July 11, 2017K1719083M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement DressingSELSubstantially Equivalent3M Companyaccessdata.fda.gov
November 28, 2016K163207Filtek One Bulk Fill RestorativeEBFSubstantially Equivalent3M Companyaccessdata.fda.gov
August 23, 2016K153571Cavilon Advanced High Endurance Skin ProtectantKMFSubstantially Equivalent3M Healthcareaccessdata.fda.gov
January 8, 2015K1420343M STERI-VAC STERILIZER/AERATORFLFSubstantially Equivalent3M Companyaccessdata.fda.gov
December 4, 2014K140657CUROS RED PORT PROTECTORQBPSubstantially EquivalentIvera Medical, Inc.accessdata.fda.gov
May 8, 2014K141081FILTEK BULK FILL POSTERIOR RESTROATIVEEBFSubstantially Equivalent3M Espe Dental Productsaccessdata.fda.gov
November 1, 2013K132109ENAMELASTLBHSubstantially EquivalentUltradent Products Inc. / Oratech, LLCaccessdata.fda.gov
March 18, 2013K1235463M ATTEST(TM) AUTO-READERFRCSubstantially Equivalent3M Companyaccessdata.fda.gov
February 28, 2013K1236793M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSINGFROSubstantially Equivalent3M Companyaccessdata.fda.gov
November 26, 2012K121171CUROS TIPQBPSubstantially EquivalentIvera Medical, Inc.accessdata.fda.gov
May 30, 2012K1204123M SPOTON TEMPERATURE MONITORING SYSTEMFLLSubstantially EquivalentArizant Healthcare, Inc.accessdata.fda.gov
May 3, 2012K1207043M LITTMANN TELESTETH ONLINE AUSCULATION SYSTEMDRGSubstantially Equivalent3M Companyaccessdata.fda.gov
March 19, 2012K120453FILTEK BULK FILL FLOWABLE RESTORATIVEEBFSubstantially Equivalent3M Espe Dental Productsaccessdata.fda.gov
January 12, 2012K111992CUROS PORT PROTECTORQBPSubstantially EquivalentIvera Medical, Inc.accessdata.fda.gov
May 5, 2011K111185RELYX LUTING PLUS AUTOMIXEMASubstantially Equivalent3M Espe Dental Productsaccessdata.fda.gov
January 21, 2011K110131LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROWN RESTORATIVEEBFSubstantially Equivalent3M Espe Dental Productsaccessdata.fda.gov
September 8, 2010K101249STERIGAGE MODEL 1243RA, 1243RB, 1243REJOJSubstantially Equivalent3M Companyaccessdata.fda.gov
May 12, 2010K100235FILTEK SUPREME ULTRA FLOWABLE RESTORATIVEEBFSubstantially Equivalent3M Companyaccessdata.fda.gov
March 10, 2010K092141VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISHLBHSubstantially Equivalent3M Espe Dental Productsaccessdata.fda.gov
December 4, 2009K0931993M COMPLY BOWIE- DICK TYPE LEAD FREE TEST PACKJOJSubstantially Equivalent3M Companyaccessdata.fda.gov
April 29, 2009K090569MODIFICATION TO: ATTEST RAPID READOUT BIOLOGICAL INDICATOR, MODE 1292FRCSubstantially Equivalent3M Companyaccessdata.fda.gov
December 17, 2008K083610FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVEEBFSubstantially Equivalent3M Companyaccessdata.fda.gov
January 17, 2008K073395GILB-2, GLASS IONOMER PROTECTIVE COATINGEMASubstantially Equivalent3M Espe Dental Productsaccessdata.fda.gov
June 26, 2006K060939RANGER IRRIGATION FLUID WARMING SYSTEMLGZSubstantially EquivalentArizant Healthcare, Inc.accessdata.fda.gov
April 24, 2006K060865BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850DWJSubstantially EquivalentArizant Healthcare, Inc.accessdata.fda.gov
September 27, 2005K052235LCREMASubstantially Equivalent3M Companyaccessdata.fda.gov
February 22, 2005K050159MODIFICATION TO: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000DQDSubstantially Equivalent3M Companyaccessdata.fda.gov
September 15, 2004K042289MDI ORTHODZESubstantially EquivalentImtec Corp.accessdata.fda.gov
October 16, 2003K031012ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO, MODEL 1294; ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO TEST PACKFRCSubstantially Equivalent3M Companyaccessdata.fda.gov
October 7, 2003K0312633M LIQUID BANDAGE, MODEL 120-LBKMFSubstantially Equivalent3M Companyaccessdata.fda.gov
August 2, 2002K022476RELYX RMGIPEMASubstantially Equivalent3M Companyaccessdata.fda.gov
June 14, 2001K011200GILB, MODEL 8010EMASubstantially Equivalent3M Companyaccessdata.fda.gov
April 13, 2001K0107813M ESPE HAUREBFSubstantially Equivalent3M Companyaccessdata.fda.gov
September 28, 2000K0024523M RELY X VENEER CEMENT TRY-IN PASTEREMASubstantially Equivalent3M Companyaccessdata.fda.gov
October 8, 1999K9923263M CLINPRO SEALANTEBCSubstantially Equivalent3M Companyaccessdata.fda.gov
August 9, 1999K9919613M LVR SYSTEMEBFSubstantially Equivalent3M Companyaccessdata.fda.gov
August 9, 1998K9816473M DENT II SYSTEMEBFSubstantially Equivalent3M Companyaccessdata.fda.gov
April 30, 1998K973741BAIR HUGGER BLOOD/FLUID WARMERBSBSubstantially EquivalentAugustine Medical, Inc.accessdata.fda.gov
February 3, 1998K9745533M UNIVERSAL ELECTROSURGICAL PAD, SPLIT (9160) 3M UNIVERSAL ELECTROSURGICAL PAD (9130)GEISubstantially Equivalent3M Healthcareaccessdata.fda.gov
January 30, 1998K9742793M UNIVERSAL ELECTROSURGICAL PAD, WITH CORD (CATALOG NUMBER 9135), 3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT WITH CORD (C)GEISubstantially Equivalent3M Healthcareaccessdata.fda.gov
December 17, 1997K9739613M DENT SYSTEM II PLUSEMASubstantially Equivalent3M Companyaccessdata.fda.gov
October 31, 1996K9637663M PROPLUS SYSTEMELWSubstantially Equivalent3M Companyaccessdata.fda.gov
August 12, 1996K9627853M DENT SYSTEMKLESubstantially Equivalent3M Companyaccessdata.fda.gov
February 5, 1996K9551033M NO STING BARRIER FILMKMFSubstantially Equivalent3M Medical Products Groupaccessdata.fda.gov
July 6, 1995K952408ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATIONJOJSubstantially EquivalentPymah Corp.accessdata.fda.gov
August 17, 1994K935267B-D DIGITAL THERMOMETERFLLSubstantially EquivalentBd Becton Dickinson Vacutainer Systems Preanalyticaccessdata.fda.gov
May 16, 1994K941189DISPOSABLE PROPHYLAXIS ANGLEEGSSubstantially EquivalentTeam Technologies, Inc.accessdata.fda.gov
February 1, 1994K925496ATI DISPOSABLE BIOLOGICAL-PLUS TEST PACKFRCSubstantially EquivalentPymah Corp.accessdata.fda.gov
January 5, 1994K9331393M VITREMER LUTING CEMENTEMASubstantially Equivalent3M Companyaccessdata.fda.gov
December 23, 1992K9250323M VITREMER TRI-CURE GLASS IONOMER SYSTEMEMASubstantially Equivalent3M Companyaccessdata.fda.gov
March 20, 1992K9204253M BRAND RESTORATIVE Z100EBFSubstantially Equivalent3M Companyaccessdata.fda.gov
March 20, 1992K920424SCOTCHBOND BRAND MULTI-PURPOSE ADHESIVE SYSTEMKLESubstantially Equivalent3M Companyaccessdata.fda.gov
December 5, 1990K904921STERI-VAC(TM) AERATOR MODEL XLFLISubstantially Equivalent3M Health Care, Ltd.accessdata.fda.gov
July 3, 1990K900771ATTEST BRAND RAPID READOUT BIOLOGICAL INDICATORFRCSubstantially Equivalent3M Companyaccessdata.fda.gov
February 13, 1990K900332EM 1149 OPTIMIZE SCOTCHPLATE CONDUC ADHES DISP ELEGEISubstantially Equivalent3M Companyaccessdata.fda.gov
August 11, 1988K882690IMPRINT VINYL POLYSILOXANE IMPRESSION MATERIALELWSubstantially Equivalent3M Companyaccessdata.fda.gov
November 14, 1985K853698SCOTCHPRIME CERAMIC PRIMEREIHSubstantially Equivalent3M Companyaccessdata.fda.gov
November 1, 1985K852192DISPOSABLE STEAM BIOLOGICAL TEST PACKFRCSubstantially EquivalentParke-Davis Co.accessdata.fda.gov
January 7, 1985K844211CONCISE LIGHT CURED WHITE SEALANTEBCSubstantially Equivalent3M Companyaccessdata.fda.gov
November 29, 1983K8333643M SCOTCHPLATE II DISPERSIVE ELECTRODEGEISubstantially Equivalent3M Companyaccessdata.fda.gov
January 12, 1983K8236893M SCOTCHPLATE 51148 SMALL CONDUCTIVEGEISubstantially Equivalent3M Companyaccessdata.fda.gov
January 12, 1982K813180SCOTCHBOND DENTAL ADHESIVEKLESubstantially Equivalent3M Companyaccessdata.fda.gov
December 31, 1981K813202THERMALOG S STEAM STERILIZATION INTEGRAJOJSubstantially EquivalentBio-Medical Sciences, Inc.accessdata.fda.gov
September 17, 1981K8015503M GERMICIDAL SURGICAL INCISE DRAPEKKXSubstantially Equivalent3M Companyaccessdata.fda.gov
March 18, 1980K800485VINYL POLYSILOXANE IMPRESSION MATERIALELWSubstantially Equivalent3M Companyaccessdata.fda.gov
July 14, 1977K771080STEAM STERILIZATION INDICATORFRCSubstantially EquivalentInfo-Chemaccessdata.fda.gov

Compare with other makers

Updated November 25, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.