FDA 510(k) Applications Submitted by Molnlycke Health Care, US LLC
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K151872 |
07/09/2015 |
Avance Y-Connector S |
MOLNLYCKE HEALTH CARE, US LLC |
K141719 |
06/25/2014 |
BIOGEL PL MICRO SURGICAL GLOVE |
MOLNLYCKE HEALTH CARE, US LLC |
K190077 |
01/16/2019 |
Biogel« PI UltraTouch S Surgical Glove, Biogel« Pl Ultra Touch S Indicator Underglove |
Molnlycke Health Care, US LLC |
K191869 |
07/12/2019 |
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 Claim |
Molnlycke Health Care, US LLC |
K202090 |
07/28/2020 |
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 Underg |
Molnlycke Health Care, US LLC |
K160379 |
02/10/2016 |
Exufiber Ag+ |
MOLNLYCKE HEALTH CARE, US LLC |
K161797 |
06/30/2016 |
Avance Tubing, Avance Y-Connector, Avance ViewPad |
MOLNLYCKE HEALTH CARE, US LLC |
K161935 |
07/14/2016 |
Avance Foam Dressing Kit - XL |
MOLNLYCKE HEALTH CARE, US LLC |
K161948 |
07/15/2016 |
Avance Gauze Dressing Kits |
MOLNLYCKE HEALTH CARE, US LLC |
K152741 |
09/23/2015 |
Mepiseal Soft Silicone Sealant |
MOLNLYCKE HEALTH CARE, US LLC |
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