Chrysalis Intelligence · Sponsors · Molnlycke Health Care Us, LLC

Molnlycke Health Care Us, LLC

Peachtree Corners, GA, US · 5 510(k) clearances

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Total clearances
5
2020-03-13 → 2023-09-15
Last 12 months
0
Product codes
3
Most recent
2023-09-15
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
KGO — — — 3 2020-11-22
DWJ System, Thermal Regulating Class II Cardiovascular 1 2023-09-15
OMP Negative Pressure Wound Therapy Powered Suction Pump Class II General, Plastic Surgery 1 2021-07-01
Filings

All 510(k) clearances (5)

Date K-number Device Code Class Specialty
2023-09-15 K232508 Barrier EasyWarm Active Self-Warming Blanket DWJ Class II Cardiovascular
2021-07-01 K203369 Avance Solo Negative Pressure Wound Therapy (NPWT) System OMP Class II General, Plastic Surgery
2020-11-22 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 — —
2020-04-10 K193573 Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro KGO — —
2020-03-13 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 — —
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence