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3M Company

FDA 510(k) & PMA Approved Devices — 51 products

Total Devices51
Categories12
Latest Approval2025-01-28
TypeNumberDevice NameCodeDate
510(k) K243501 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M FRC 2025-01-28 View
510(k) K242538 3M™ 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 490M FRC 2024-11-25 View
510(k) K241959 3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M) FRC 2024-10-18 View
510(k) K241710 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M FRC 2024-09-12 View
510(k) K241542 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD) FRC 2024-06-27 View
510(k) K240717 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E FRC 2024-06-27 View
510(k) DEN230068 3M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder 10135CH 3M™ Attest™ eBowie-Dick Auto-reader 1190 JOJ 2024-05-21 View
510(k) K233814 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M) FRC 2024-03-15 View
510(k) K222578 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) KKX 2023-05-18 View
510(k) K222508 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 JOJ 2022-11-01 View
510(k) K222152 3M™ Attest™ Hydrogen Peroxide Indicator Tape 1228 JOJ 2022-09-23 View
510(k) K211705 3M Attest Rapid Readout Biological Indicator, 1295 FRC 2022-06-28 View
510(k) K220942 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES) JOJ 2022-06-24 View
510(k) K220564 3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 1355 JOJ 2022-05-23 View
510(k) K220507 3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large PZW 2022-05-23 View
510(k) K212022 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E QKM 2022-04-20 View
510(k) K213809 3M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge Pack, 3M Attest Auto-reader, 3M Attest Mini Auto-reader FRC 2022-04-06 View
510(k) K212081 3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228 JOJ 2021-09-05 View
510(k) K210605 3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation DWJ 2021-04-29 View
510(k) K210603 3M Bair Hugger Temperature Management System (Model 675) DWJ 2021-03-30 View
510(k) K210277 3M Attest Rapid Readout Biological Indicator, 1295 FRC 2021-03-03 View
510(k) K200996 3M Attest Rapid Readout Biological Indicator FRC 2020-12-11 View
510(k) K203458 3M Comply Hydrogen Peroxide Chemical Indicator 1248 JOJ 2020-12-11 View
510(k) K203285 3M Comply Hydrogen Peroxide Indicator Tape 1228 JOJ 2020-12-10 View
510(k) K203284 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator QKM 2020-12-07 View
510(k) K200299 Curos Jet Disinfecting Cap QBP 2020-10-29 View
510(k) K200835 3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad FRO 2020-09-04 View
510(k) K200766 3M Attest Steam Chemical Integrator Test Pack FRC 2020-07-02 View
510(k) K192550 3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H FRC 2020-06-05 View
510(k) K193154 3M Attest Super Rapid 5 Steam-Plus Challenge Pack FRC 2020-02-07 View
510(k) K193254 3M Attest Steam Chemical Integrator JOJ 2019-12-23 View
510(k) K191236 3M™ Attest™ Steam Chemical Integrators JOJ 2019-11-22 View
510(k) K192937 3M Comply Hydrogen Peroxide Chemical Indicator JOJ 2019-11-16 View
510(k) K192673 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 JOJ 2019-10-28 View
510(k) K192119 3M Clarity Aligners NXC 2019-09-05 View
510(k) K183211 3M Comply Hydrogen Peroxide Chemical Indicator JOJ 2019-02-26 View
510(k) K183209 3M Comply Hydrogen Peroxide Indicator Tape JOJ 2019-02-15 View
510(k) K183159 3M Clarity Aligners NXC 2018-11-26 View
510(k) K173519 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 FRC 2018-04-23 View
510(k) K173437 3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H FRC 2018-03-19 View
510(k) K173435 3M Attest Rapid Readout Biological Indicator FRC 2018-02-09 View
510(k) K173584 3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest Auto-reader FRC 2018-01-22 View
510(k) K171373 3M Bair Hugger Model 675 Total Temperature Management System DWJ 2017-10-10 View
510(k) K170321 3M Comply Hydrogen Peroxide Chemical Indicator 1248 JOJ 2017-08-14 View
510(k) K170563 3M Comply Hydrogen Peroxide Indicator Tape JOJ 2017-07-27 View
510(k) K171003 3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader FRC 2017-07-21 View
510(k) K171908 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing SEL 2017-07-11 View
510(k) K153410 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing SEL 2017-05-15 View
510(k) K170330 3M Protemp Cement Temporary Dental Cement EMA 2017-02-06 View
510(k) K163207 Filtek One Bulk Fill Restorative EBF 2016-11-28 View
510(k) K160546 3M Attest Rapid Readout Biological Indicator FRC 2016-06-09 View