FDA 510(k) Applications Submitted by 3M Company

FDA 510(k) Number Submission Date Device Name Applicant
K962065 05/28/1996 3M VITREBOND LIGHT CURE GLASS IONOMER/BASE 3M COMPANY
K963766 09/19/1996 3M PROPLUS SYSTEM 3M COMPANY
K981325 04/13/1998 3M M.G. MATERIAL 3M COMPANY
K040890 03/24/2004 3M TEGADERM SILVER 3M COMPANY
K053256 11/22/2005 3M TEGADERM SILVER (AG) MESH 3M COMPANY
K203284 11/09/2020 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 3M Company
K031263 04/21/2003 3M LIQUID BANDAGE, MODEL 120-LB 3M COMPANY
K982893 08/17/1998 3M TEGASORB HYDROCOLLOID DRESSING 3M COMPANY
K982892 08/17/1998 3M TEGASORB THIN HYDROCOLLOID DRESSING 3M COMPANY
K972962 08/11/1997 3M CDI BLOOD PARAMETER MONITORING SYSTEM 500 3M COMPANY
K970168 01/16/1997 3M QUIKPLUS SYSTEM 3M COMPANY
K955098 11/07/1995 3M MINI-DRIVER ELECTRIC SYSTEM 3M COMPANY
K210603 03/01/2021 3M Bair Hugger Temperature Management System (Model 675) 3M Company
K090569 03/02/2009 MODIFICATION TO: ATTEST RAPID READOUT BIOLOGICAL INDICATOR, MODE 1292 3M COMPANY
K053409 12/07/2005 3M LIQUID BANDAGE 3M COMPANY
K001114 04/06/2000 3M QUIK TEMP TEMPORIZATION MATERIAL 3M COMPANY
K200299 02/06/2020 Curos Jet Disinfecting Cap 3M Company
K052128 08/05/2005 3M ATTEST 293 AUTO-READER, 3M ATTEST 293G AUTO-READER 3M COMPANY
K031012 03/31/2003 ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO, MODEL 1294; ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO TEST PACK 3M COMPANY
K063023 10/02/2006 3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1870 3M COMPANY
DEN060009 10/03/2006 3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE; 3M N95 HOME RESPIRATOR 3M COMPANY
K955382 11/24/1995 3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95 3M COMPANY
K050159 01/25/2005 MODIFICATION TO: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000 3M COMPANY
K051790 07/01/2005 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 4100 3M COMPANY
K041934 07/19/2004 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000 3M COMPANY
K122467 08/13/2012 3M TRUE DEFINITION SCANNER 3M COMPANY
K122569 08/23/2012 LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D LAVA ULTIMATE IMPLANT CROWN RESTOR 3M COMPANY
K170330 02/02/2017 3M Protemp Cement Temporary Dental Cement 3M Company
K220507 02/22/2022 3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large 3M Company
K210605 03/01/2021 3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation 3M Company
K222578 08/25/2022 3MÖ IobanÖ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) 3M Company
K213809 12/06/2021 3M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge Pack, 3M Attest Auto-reader, 3M Attest Mini Auto-reader 3M Company
K192550 09/17/2019 3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H 3M Company
K150622 03/11/2015 3M Comply Hydrogen Peroxide Chemical Indicator 1248 3M Company
K150694 03/18/2015 3M Comply Hydrogen Peroxide Indicator Tape 1228 3M Company
K200835 03/31/2020 3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad 3M Company
K171003 04/04/2017 3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader 3M Company
K173437 11/03/2017 3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H 3M Company
K173519 11/14/2017 3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus Chaallenge Pack, 3M Attest Auto-reader, 3M Attest Auto-reader 3M Company
K173584 11/20/2017 3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest Auto-reader 3M Company
K121069 04/09/2012 3M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK 3M COMPANY
K101834 07/01/2010 3M LITTMANN SCOPE-TO SCOPE SOFTWARE SYSTEM 3M COMPANY
K093199 10/09/2009 3M COMPLY BOWIE- DICK TYPE LEAD FREE TEST PACK 3M COMPANY
K083903 12/29/2008 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3200 3M COMPANY
K123679 11/30/2012 3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING 3M COMPANY
K020589 02/22/2002 3M COMPLY 1228 GAS PLASMA INDICATOR TAPE 3M COMPANY
K120704 03/08/2012 3M LITTMANN TELESTETH ONLINE AUSCULATION SYSTEM 3M COMPANY
K171373 05/10/2017 3M Bair Hugger Model 675 Total Temperature Management System 3M Company
K090519 02/26/2009 VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247 3M COMPANY
K011167 04/16/2001 XSE 3M COMPANY
K011200 04/19/2001 GILB, MODEL 8010 3M COMPANY
K022476 07/29/2002 RELYX RMGIP 3M COMPANY
K052235 08/17/2005 LCR 3M COMPANY
K991961 06/10/1999 3M LVR SYSTEM 3M COMPANY
K992326 07/13/1999 3M CLINPRO SEALANT 3M COMPANY
K992489 07/26/1999 3M TR SYSTEM 3M COMPANY
K973961 10/16/1997 3M DENT SYSTEM II PLUS 3M COMPANY
K981647 05/11/1998 3M DENT II SYSTEM 3M COMPANY
K971446 04/21/1997 3M UNIVERSAL ELECTROSURGICAL PAD SPLIT/SOLID(9130&9160) 3M COMPANY
K003723 12/04/2000 3M LITTMANN 3M COMPANY
K123085 10/01/2012 FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOCKINGS; FUTURO (TM) TRAVEL PANTYHOSE 3M COMPANY
K972355 06/25/1997 3M AURORA SYSTEM 3M COMPANY
K110457 02/17/2011 3M TEGADERM MATRIX DRESSING 3M COMPANY
K063458 11/15/2006 3M TEGADERM CHG DRESSING 3M COMPANY
K210277 02/01/2021 3M Attest Rapid Readout Biological Indicator, 1295 3M Company
K200766 03/25/2020 3M Attest Steam Chemical Integrator Test Pack 3M Company
K200996 04/16/2020 3M Attest Rapid Readout Biological Indicator 3M Company
K191236 05/08/2019 3MÖ AttestÖ Steam Chemical Integrators 3M Company
K211705 06/03/2021 3M Attest Rapid Readout Biological Indicator, 1295 3M Company
K212022 06/29/2021 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E 3M Company
K212081 07/02/2021 3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228 3M Company
K192673 09/26/2019 3MÖ ComplyÖ Hydrogen Peroxide Indicator Tape 1228 3M Company
K192937 10/18/2019 3M Comply Hydrogen Peroxide Chemical Indicator 3M Company
K203285 11/09/2020 3M Comply Hydrogen Peroxide Indicator Tape 1228 3M Company
K193154 11/14/2019 3M Attest Super Rapid 5 Steam-Plus Challenge Pack 3M Company
K193254 11/26/2019 3M Attest Steam Chemical Integrator 3M Company
K150477 02/24/2015 3M Comply Indicator Tape for Ethylene Oxide (EO) Sterilization 3M COMPANY
K160546 02/26/2016 3M Attest Rapid Readout Biological Indicator 3M COMPANY
K152060 07/24/2015 3M Attest Rapid Readout Biological Indicator 1295 3M COMPANY
K142034 07/28/2014 3M STERI-VAC STERILIZER/AERATOR 3M COMPANY
K153410 11/25/2015 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing 3M COMPANY
K171908 06/26/2017 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing 3M Company
K170321 02/01/2017 3M Comply Hydrogen Peroxide Chemical Indicator 1248 3M COMPANY
K170563 02/27/2017 3M Comply Hydrogen Peroxide Indicator Tape 3M Company
K173435 11/03/2017 3M Attest Rapid Readout Biological Indicator 3M Company
K183211 11/19/2018 3M Comply Hydrogen Peroxide Chemical Indicator 3M Company
K183209 11/19/2018 3M Comply Hydrogen Peroxide Indicator Tape 3M Company
K970500 02/10/1997 3M SUSTEL DENTAL SYSTEM 3M COMPANY
K100235 01/26/2010 FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE 3M COMPANY
K010781 03/15/2001 3M ESPE HAUR 3M COMPANY
K962785 07/17/1996 3M DENT SYSTEM 3M COMPANY
K072733 09/27/2007 3M ESPE ADULT CROWN 3M COMPANY
K163207 11/15/2016 Filtek One Bulk Fill Restorative 3M Company
K083610 12/08/2008 FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE 3M COMPANY
K031287 04/23/2003 STERI-DRAPE SURGICAL DRAPES 3M COMPANY
K002452 08/10/2000 3M RELY X VENEER CEMENT TRY-IN PASTER 3M COMPANY
K091632 06/04/2009 SPK SEALANT 3M COMPANY
K151302 05/15/2015 Clinpro Varnish 3m Company
K004009 12/26/2000 3M ATTEST 290 AUTO-READER 3M COMPANY
K140392 02/14/2014 3M ATTEST RAPID READOUT BIOLOGICAL INDICATOR / 3M ATTEST AUTO-READER 3M COMPANY
K101249 05/04/2010 STERIGAGE MODEL 1243RA, 1243RB, 1243RE 3M COMPANY
K121484 05/18/2012 3M ATTEST(TM) SUPER RAPID READOUT BIOLOGICAL INDICATOR, 3M ATTEST(TM) AUTO-READER 3M COMPANY
K121593 05/31/2012 3M ATTEST (TM) SUPER RADID READOUT STEAM CHALLENGE PACK 3M ATTEST(TM) SUPER RAPID 5 STEAM-PLUS CHALLENGE PACK 3M COMPANY
K101528 06/02/2010 3M COMPLY LEAD FREE PROCESS INDICATORS FOR STEAM 3M COMPANY
K101910 07/09/2010 3M ATTEST RAPID READOUT STEAM PROCESS CHALLENGE DEVICE, MODEL 1296V, 3M ATTEST RAPID READOUT STEAM-PLUS 3M COMPANY
K123546 11/19/2012 3M ATTEST(TM) AUTO-READER 3M COMPANY
K192119 08/06/2019 3M Clarity Aligners 3M Company
K183159 11/15/2018 3M Clarity Aligners 3M Company
K220564 02/28/2022 3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 1355 3M Company
K220942 03/31/2022 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES) 3M Company
K222152 07/20/2022 3MÖ AttestÖ Hydrogen Peroxide Indicator Tape 1228 3M Company
K222508 08/18/2022 3MÖ ComplyÖ Hydrogen Peroxide Chemical Indicator 1248 3M Company
K203458 11/24/2020 3M Comply Hydrogen Peroxide Chemical Indicator 1248 3M Company


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