Molnlycke Health Care, US LLC
Anderson, SC, US
MOLNLYCKE HEALTH CARE, US LLC appears in FDA device records in Anderson, SC. FDA records list 27 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 27 510(k) clearances for Molnlycke Health Care, US LLC between 2006 and 2023. The busiest year on record is 2016, with 6. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2007 | 4 |
| 2008 | 1 |
| 2011 | 2 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 4 |
| 2016 | 6 |
| 2019 | 1 |
| 2020 | 3 |
| 2021 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K232508 | Barrier EasyWarm Active Self-Warming Blanket | DWJ | Substantially Equivalent | |
| K203369 | Avance Solo Negative Pressure Wound Therapy (NPWT) System | OMP | Substantially Equivalent | |
| K202090 | 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 | KGO | Substantially Equivalent | |
| K193573 | Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro | KGO | Substantially Equivalent | |
| K191869 | Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel(R) PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim | KGO | Substantially Equivalent | |
| K190077 | Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove | KGO | Substantially Equivalent | |
| K161939 | Avance Abdominal Dressing Kit | OXJ | Substantially Equivalent | |
| K161935 | Avance Foam Dressing Kit - XL | OMP | Substantially Equivalent | |
| K161948 | Avance Gauze Dressing Kits | OMP | Substantially Equivalent | |
| K161797 | Avance Tubing, Avance Y-Connector, Avance ViewPad | OMP | Substantially Equivalent | |
| K160379 | Exufiber Ag+ | FRO | Substantially Equivalent | |
| K152741 | Mepiseal Soft Silicone Sealant | OMP | Substantially Equivalent | |
| K151872 | Avance Y-Connector S | OMP | Substantially Equivalent | |
| K150146 | Biogel PI Micro Indicator Underglove | KGO | Substantially Equivalent | |
| K141847 | AVANCE FOAM DRESSING KITS | OMP | Substantially Equivalent | |
| K140477 | BIOGEL PS SURGICAL GLOVE SERIES, BIOGEL SKINSENSE SURGICAL GLOVE SERIES | KGO | Substantially Equivalent | |
| K141719 | BIOGEL PL MICRO SURGICAL GLOVE | KGO | Substantially Equivalent | |
| K132048 | BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET | DWJ | Substantially Equivalent | |
| K111413 | BIOGEL (R) INDICATOR (R) UNDERGLOVE | KGO | Substantially Equivalent | |
| K112257 | BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVE | KGO | Substantially Equivalent | |
| K112089 | BIOGEL ORTHOPOR BROWN SURGICAL GLOVE | KGO | Substantially Equivalent | |
| K081180 | SKINSENSE POLYISOPRENE UNDERGLOVE | KGO | Substantially Equivalent | |
| K071700 | BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENT | KGO | Substantially Equivalent | |
| K071465 | BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENT | KGO | Substantially Equivalent | |
| K071565 | BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENT | KGO | Substantially Equivalent | |
| K071414 | BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | KGO | Substantially Equivalent | |
| K062847 | BIOGEL ECLIPSE INDICATOR UNDERGLOVE | KGO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004824904 | 3004824904 | MOLNLYCKE HEALTH CARE, US LLC | 100 Schmid Plaza Road, Anderson, SC 29624 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Molnlycke Health Care, US LLC edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain