Molnlycke Health Care Us, LLC is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
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
Molnlycke Health Care Us, LLC has 27 FDA 510(k) cleared medical devices. Based in Norcross, US.
Last cleared in 2023. Active since 2006. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Molnlycke Health Care Us, LLC Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Molnlycke Health Care Us, LLC
27 devices
Cleared
Sep 15, 2023
Barrier EasyWarm Active Self-Warming Blanket
Cardiovascular
28d
Cleared
Jul 01, 2021
Avance Solo Negative Pressure Wound Therapy (NPWT) System
General & Plastic Surgery
227d
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
Nov 17, 2016
Avance Abdominal Dressing Kit
General & Plastic Surgery
126d
Cleared
Nov 04, 2016
Avance Foam Dressing Kit - XL
General & Plastic Surgery
113d
Cleared
Nov 03, 2016
Avance Gauze Dressing Kits
General & Plastic Surgery
111d
Cleared
Oct 19, 2016
Avance Tubing, Avance Y-Connector, Avance ViewPad
General & Plastic Surgery
111d
Cleared
Aug 25, 2016
Exufiber Ag+
General & Plastic Surgery
197d
Cleared
Jan 22, 2016
Mepiseal Soft Silicone Sealant
General & Plastic Surgery
121d