Medical Device Manufacturer · US , Norcross , GA

Molnlycke Health Care Us, LLC - FDA 510(k) Cleared Devices

27 submissions · 27 cleared · Since 2006
27
Total
27
Cleared
0
Denied

FDA 510(k) cleared devices by Molnlycke Health Care Us, LLC General Hospital

16 devices
1-16 of 16
Cleared Nov 22, 2020
Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons /...
K202090 · KGO
General Hospital · 117d
Cleared Apr 10, 2020
Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI...
K193573 · KGO
General Hospital · 109d
Cleared Mar 13, 2020
Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential...
K191869 · KGO
General Hospital · 245d
Cleared May 24, 2019
Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator...
K190077 · KGO
General Hospital · 128d
Cleared Aug 31, 2015
Biogel PI Micro Indicator Underglove
K150146 · KGO
General Hospital · 221d
Cleared Mar 23, 2015
BIOGEL PS SURGICAL GLOVE SERIES, BIOGEL SKINSENSE SURGICAL GLOVE SERIES
K140477 · KGO
General Hospital · 390d
Cleared Sep 04, 2014
BIOGEL PL MICRO SURGICAL GLOVE
K141719 · KGO
General Hospital · 71d
Cleared Jan 30, 2012
BIOGEL (R) INDICATOR (R) UNDERGLOVE
K111413 · KGO
General Hospital · 255d
Cleared Sep 20, 2011
BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVE
K112257 · KGO
General Hospital · 46d
Cleared Aug 24, 2011
BIOGEL ORTHOPOR BROWN SURGICAL GLOVE
K112089 · KGO
General Hospital · 34d
Cleared Aug 26, 2008
SKINSENSE POLYISOPRENE UNDERGLOVE
K081180 · KGO
General Hospital · 123d
Cleared Sep 11, 2007
BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENT
K071465 · KGO
General Hospital · 105d
Cleared Sep 11, 2007
BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENT
K071700 · KGO
General Hospital · 82d
Cleared Sep 10, 2007
BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT...
K071414 · KGO
General Hospital · 112d
Cleared Sep 10, 2007
BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENT
K071565 · KGO
General Hospital · 95d
Cleared Dec 20, 2006
BIOGEL ECLIPSE INDICATOR UNDERGLOVE
K062847 · KGO
General Hospital · 77d
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