Molnlycke Health Care Us, LLC - FDA 510(k) Cleared Devices
Recent clearances: Barrier EasyWarm Active Self-Warming Blanket, Avance Solo Negative Pressure Wound Therapy (NPWT) System, 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 Claim
27
Total
27
Cleared
0
Denied
FDA 510(k) Regulatory Record - Molnlycke Health Care Us, LLC General Hospital ✕
16 devices
Cleared
Nov 22, 2020
Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons /...
General Hospital
117d
Cleared
Apr 10, 2020
Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI...
General Hospital
109d
Cleared
Mar 13, 2020
Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential...
General Hospital
245d
Cleared
May 24, 2019
Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator...
General Hospital
128d
Cleared
Aug 31, 2015
Biogel PI Micro Indicator Underglove
General Hospital
221d
Cleared
Mar 23, 2015
BIOGEL PS SURGICAL GLOVE SERIES, BIOGEL SKINSENSE SURGICAL GLOVE SERIES
General Hospital
390d
Cleared
Sep 04, 2014
BIOGEL PL MICRO SURGICAL GLOVE
General Hospital
71d
Cleared
Jan 30, 2012
BIOGEL (R) INDICATOR (R) UNDERGLOVE
General Hospital
255d
Cleared
Sep 20, 2011
BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVE
General Hospital
46d
Cleared
Aug 24, 2011
BIOGEL ORTHOPOR BROWN SURGICAL GLOVE
General Hospital
34d
Cleared
Aug 26, 2008
SKINSENSE POLYISOPRENE UNDERGLOVE
General Hospital
123d
Cleared
Sep 11, 2007
BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENT
General Hospital
105d