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Molnlycke Health Care Us, LLC

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
27
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K232508Barrier EasyWarm Active Self-Warming BlanketSeptember 15, 2023
K203369Avance Solo Negative Pressure Wound Therapy (NPWT) SystemJuly 1, 2021
K202090Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove,November 22, 2020
K193573Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel April 10, 2020
K191869Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel(R) PI UltraToMarch 13, 2020
K190077Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator UndergloveMay 24, 2019
K161939Avance Abdominal Dressing KitNovember 17, 2016
K161935Avance Foam Dressing Kit - XLNovember 4, 2016
K161948Avance Gauze Dressing KitsNovember 3, 2016
K161797Avance Tubing, Avance Y-Connector, Avance ViewPadOctober 19, 2016
K160379Exufiber Ag+August 25, 2016
K152741Mepiseal Soft Silicone SealantJanuary 22, 2016
K151872Avance Y-Connector SNovember 2, 2015
K150146Biogel PI Micro Indicator UndergloveAugust 31, 2015
K141847AVANCE FOAM DRESSING KITSMarch 26, 2015
K140477BIOGEL PS SURGICAL GLOVE SERIES, BIOGEL SKINSENSE SURGICAL GLOVE SERIESMarch 23, 2015
K141719BIOGEL PL MICRO SURGICAL GLOVESeptember 4, 2014
K132048BARRIER EASYWARM ACTIVE SELF-WARMING BLANKETNovember 6, 2013
K111413BIOGEL (R) INDICATOR (R) UNDERGLOVEJanuary 30, 2012
K112257BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVESeptember 20, 2011