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3M Company

FDA 510(k) & PMA Approved Devices — 50 products

Total Devices50
Categories12
Latest FDA decision2025-01-28
TypeNumberDevice NameCodeDateActions
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 490MFRC2025-01-28 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 490MFRC2024-11-25 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)FRC2024-10-18 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 490MFRC2024-09-12 View
510(k) K241542 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)FRC2024-06-27 View
510(k) K240717 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348EFRC2024-06-27 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)FRC2024-03-15 View
510(k) K222578 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)KKX2023-05-18 View
510(k) K222508 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248JOJ2022-11-01 View
510(k) K222152 3M™ Attest™ Hydrogen Peroxide Indicator Tape 1228JOJ2022-09-23 View
510(k) K211705 3M Attest Rapid Readout Biological Indicator, 1295FRC2022-06-28 View
510(k) K220942 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)JOJ2022-06-24 View
510(k) K220564 3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 1355JOJ2022-05-23 View
510(k) K220507 3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, LargePZW2022-05-23 View
510(k) K212022 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348EQKM2022-04-20 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-readerFRC2022-04-06 View
510(k) K212081 3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228JOJ2021-09-05 View
510(k) K210605 3M Bair Hugger Universal Warming Gown made with Thinsulate InsulationDWJ2021-04-29 View
510(k) K210603 3M Bair Hugger Temperature Management System (Model 675)DWJ2021-03-30 View
510(k) K210277 3M Attest Rapid Readout Biological Indicator, 1295FRC2021-03-03 View

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