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Molnlycke Health Care Us, LLC

FDA 510(k) & PMA Approved Devices — 12 products

Total Devices12
Categories5
Latest FDA decision2023-09-15
TypeNumberDevice NameCodeDateActions
510(k) K232508 Barrier EasyWarm Active Self-Warming BlanketDWJ2023-09-15 View
510(k) K203369 Avance Solo Negative Pressure Wound Therapy (NPWT) SystemOMP2021-07-01 View
510(k) K202090 Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove, Biogel PI Micro Indicator Underglove, Biogel PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential ClaimKGO2020-11-22 View
510(k) K193573 Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI MicroKGO2020-04-10 View
510(k) K191869 Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel(R) PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential ClaimKGO2020-03-13 View
510(k) K190077 Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator UndergloveKGO2019-05-24 View
510(k) K161939 Avance Abdominal Dressing KitOXJ2016-11-17 View
510(k) K161935 Avance Foam Dressing Kit - XLOMP2016-11-04 View
510(k) K161948 Avance Gauze Dressing KitsOMP2016-11-03 View
510(k) K161797 Avance Tubing, Avance Y-Connector, Avance ViewPadOMP2016-10-19 View
510(k) K160379 Exufiber Ag+FRO2016-08-25 View
510(k) K152741 Mepiseal Soft Silicone SealantOMP2016-01-22 View
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