FDA 510(k) Applications Submitted by MOLNLYCKE HEALTH CARE US, LLC
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K112257 |
08/05/2011 |
BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVE |
MOLNLYCKE HEALTH CARE US, LLC |
| K141847 |
07/09/2014 |
AVANCE FOAM DRESSING KITS |
MOLNLYCKE HEALTH CARE US, LLC |
| K140477 |
02/26/2014 |
BIOGEL PS SURGICAL GLOVE SERIES, BIOGEL SKINSENSE SURGICAL GLOVE SERIES |
MOLNLYCKE HEALTH CARE US, LLC |
| K132048 |
07/02/2013 |
BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET |
MOLNLYCKE HEALTH CARE US, LLC |
| K150146 |
01/22/2015 |
Biogel PI Micro Indicator Underglove |
MOLNLYCKE HEALTH CARE US, LLC |
| K161939 |
07/14/2016 |
Avance Abdominal Dressing Kit |
Molnlycke Health Care US, LLC |
| K232508 |
08/18/2023 |
Barrier EasyWarm Active Self-Warming Blanket |
Molnlycke Health Care US, LLC |
| K203369 |
11/16/2020 |
Avance Solo Negative Pressure Wound Therapy (NPWT) System |
Molnlycke Health Care US, LLC |
| K081180 |
04/25/2008 |
SKINSENSE POLYISOPRENE UNDERGLOVE |
MOLNLYCKE HEALTH CARE US, LLC |
| K071414 |
05/21/2007 |
BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
MOLNLYCKE HEALTH CARE US, LLC |
| K071565 |
06/07/2007 |
BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENT |
MOLNLYCKE HEALTH CARE US, LLC |
| K062847 |
10/04/2006 |
BIOGEL ECLIPSE INDICATOR UNDERGLOVE |
MOLNLYCKE HEALTH CARE US, LLC |
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