Company · US
Molnlycke Health Care Us, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2023. Name variants (Inc, Corp, punctuation) are merged.
27510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 15, 2023 | K232508 | Barrier EasyWarm Active Self-Warming Blanket Molnlycke Health Care Us, LLC | DWJ |
| Jul 1, 2021 | K203369 | Avance Solo Negative Pressure Wound Therapy (NPWT) System Molnlycke Health Care Us, LLC | OMP |
| Nov 22, 2020 | K202090 | Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove, Biogel PI Micro Ind Molnlycke Health Care Us, LLC | KGO |
| Apr 10, 2020 | K193573 | Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro Molnlycke Health Care Us, LLC | KGO |
| Mar 13, 2020 | K191869 | Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel(R) PI UltraTouch S Indicator Unde Molnlycke Health Care Us, LLC | KGO |
| May 24, 2019 | K190077 | Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove Molnlycke Health Care Us, LLC | KGO |
| Nov 17, 2016 | K161939 | Avance Abdominal Dressing Kit Molnlycke Health Care Us, LLC | OXJ |
| Nov 4, 2016 | K161935 | Avance Foam Dressing Kit - XL Molnlycke Health Care Us, LLC | OMP |
| Nov 3, 2016 | K161948 | Avance Gauze Dressing Kits Molnlycke Health Care Us, LLC | OMP |
| Oct 19, 2016 | K161797 | Avance Tubing, Avance Y-Connector, Avance ViewPad Molnlycke Health Care Us, LLC | OMP |
| Aug 25, 2016 | K160379 | Exufiber Ag+ Molnlycke Health Care Us, LLC | FRO |
| Jan 22, 2016 | K152741 | Mepiseal Soft Silicone Sealant Molnlycke Health Care Us, LLC | OMP |
| Nov 2, 2015 | K151872 | Avance Y-Connector S Molnlycke Health Care Us, LLC | OMP |
| Aug 31, 2015 | K150146 | Biogel PI Micro Indicator Underglove Molnlycke Health Care Us, LLC | KGO |
| Mar 26, 2015 | K141847 | AVANCE FOAM DRESSING KITS Molnlycke Health Care Us, LLC | OMP |
| Mar 23, 2015 | K140477 | BIOGEL PS SURGICAL GLOVE SERIES, BIOGEL SKINSENSE SURGICAL GLOVE SERIES Molnlycke Health Care Us, LLC | KGO |
| Sep 4, 2014 | K141719 | BIOGEL PL MICRO SURGICAL GLOVE Molnlycke Health Care Us, LLC | KGO |
| Nov 6, 2013 | K132048 | BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET Molnlycke Health Care Us, LLC | DWJ |
| Jan 30, 2012 | K111413 | BIOGEL (R) INDICATOR (R) UNDERGLOVE Molnlycke Health Care Us, LLC | KGO |
| Sep 20, 2011 | K112257 | BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVE Molnlycke Health Care Us, LLC | KGO |
| Aug 24, 2011 | K112089 | BIOGEL ORTHOPOR BROWN SURGICAL GLOVE Molnlycke Health Care Us, LLC | KGO |
| Aug 26, 2008 | K081180 | SKINSENSE POLYISOPRENE UNDERGLOVE Molnlycke Health Care Us, LLC | KGO |
| Sep 11, 2007 | K071700 | BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENT Molnlycke Health Care Us, LLC | KGO |
| Sep 11, 2007 | K071465 | BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENT Molnlycke Health Care Us, LLC | KGO |
| Sep 10, 2007 | K071565 | BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENT Molnlycke Health Care Us, LLC | KGO |
| Sep 10, 2007 | K071414 | BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) Molnlycke Health Care Us, LLC | KGO |
| Dec 20, 2006 | K062847 | BIOGEL ECLIPSE INDICATOR UNDERGLOVE Molnlycke Health Care Us, LLC | KGO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||