FDA 510(k) Applications Submitted by Megan Bevill
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K150146 |
01/22/2015 |
Biogel PI Micro Indicator Underglove |
MOLNLYCKE HEALTH CARE US, LLC |
| K160379 |
02/10/2016 |
Exufiber Ag+ |
MOLNLYCKE HEALTH CARE, US LLC |
| K100412 |
02/16/2010 |
BIOLOX DELTA CERAMIC FEMORAL HEADS |
SMITH & NEPHEW, INC. |
| K110837 |
03/25/2011 |
REVISION PROTHESIS |
SMITH & NEPHEW, INC. |
| K100897 |
03/31/2010 |
LEGION POROUS + HA TIBIAL BASEPLATES |
SMITH & NEPHEW, INC. |
| K071160 |
04/26/2007 |
REFLECTION, TANDEM UNIPOLAR |
SMITH & NEPHEW, INC. |
| K111635 |
06/13/2011 |
SMITH & NEPHEW RJ CONSTRAINED LINERS |
SMITH & NEPHEW, INC. |
| K161797 |
06/30/2016 |
Avance Tubing, Avance Y-Connector, Avance ViewPad |
MOLNLYCKE HEALTH CARE, US LLC |
| K092098 |
07/14/2009 |
PATIENT SPECIFIC ACETABULAR RECONSTRUCTION PROSTHESIS |
SMITH & NEPHEW, INC. |
| K161935 |
07/14/2016 |
Avance Foam Dressing Kit - XL |
MOLNLYCKE HEALTH CARE, US LLC |
| K161939 |
07/14/2016 |
Avance Abdominal Dressing Kit |
Molnlycke Health Care US, LLC |
| K161948 |
07/15/2016 |
Avance Gauze Dressing Kits |
MOLNLYCKE HEALTH CARE, US LLC |
| K092386 |
08/05/2009 |
R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS |
SMITH & NEPHEW, INC. |
| K082358 |
08/18/2008 |
SMITH & NEPHEW, INC. PATIENT MATCHED TECHNOLOGY |
SMITH & NEPHEW, INC. |
| K232508 |
08/18/2023 |
Barrier EasyWarm Active Self-Warming Blanket |
Molnlycke Health Care US, LLC |
| K102370 |
08/20/2010 |
R3 XLPE ANTEVERTED LINERS |
SMITH & NEPHEW, INC. |
| K072531 |
09/07/2007 |
LEGION STEM WITH HOLES |
SMITH & NEPHEW, INC. |
| K152741 |
09/23/2015 |
Mepiseal Soft Silicone Sealant |
MOLNLYCKE HEALTH CARE, US LLC |
| K113012 |
10/11/2011 |
PROMOS MODULAR SHOULDER SYSTEM |
SMITH & NEPHEW, INC. |
| K093363 |
10/28/2009 |
COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS |
SMITH & NEPHEW, INC. |
| K203369 |
11/16/2020 |
Avance Solo Negative Pressure Wound Therapy (NPWT) System |
Molnlycke Health Care US, LLC |
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