# Molnlycke Health Care, Inc.

- Location (FDA's records): Norcross, GA
- FDA decisions: 19 (1998–2014): 19 510(k) clearances
- Names in FDA's records: Molnlycke Health Care, Inc. (10); Molnlycke Health Care (9)
- Product codes: FRO (4), KKX (3), FYA (3), MGQ (2), MGP (2), OXJ (1), MSH (1), KMF (1), OMP (1), LZA (1)
- Predicates its devices cite: 27 (5 its own); citations of its devices by later devices: 21 (5 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Surgikos, Inc.: 13 (https://510kreport.com/company/surgikos)
- Smith & Nephew, Inc.: 2 (https://510kreport.com/company/smith-nephew)
- Johnson & Johnson Medical, Inc.: 2 (https://510kreport.com/company/johnson-johnson-medical)
- Louis M. Gerson Co., Inc.: 1 (https://510kreport.com/company/louis-m-gerson)
- Molnlycke Clinical Products AB: 1 (https://510kreport.com/company/molnlycke-clinical-products)
- Laboratoires Urgo: 1 (https://510kreport.com/company/laboratoires-urgo)
- Sgmp Co., Ltd.: 1 (https://510kreport.com/company/sgmp)
- Johnson & Johnson Medical, Div. of Ethicon, Inc.: 1 (https://510kreport.com/company/johnson-johnson-medical-div-of-ethicon)

## Firms that cite its devices most
- Molnlycke Health Care Us, LLC: 3 (https://510kreport.com/company/molnlycke-health-care-us)
- Huizhou Foryou Medical Devices Co., Ltd.: 2 (https://510kreport.com/company/huizhou-foryou-medical-devices)
- Covalon Technologies, Ltd.: 1 (https://510kreport.com/company/covalon-technologies)
- Advanced Medical Solutions Limited: 1 (https://510kreport.com/company/advanced-medical-solutions)
- Talley Group, Ltd.: 1 (https://510kreport.com/company/talley-group)
- Curaline, Inc.: 1 (https://510kreport.com/company/curaline)
- Convatec Limited: 1 (https://510kreport.com/company/convatec)
- Monlycke Health Care: 1 (https://510kreport.com/company/monlycke-health-care)

## Its most-cited devices
- K100029: Mepilex Border AG Dressing (2010), cited by 5
- K984371: Mepitel Non Adherent Silicone Dressing (1999), cited by 4
- K061554: Mepilex AG Absorbent Silicone-Coated Dressing (2007), cited by 4
- K122132: Avance Foam Dressing Kit Incl. Transparent Film, Transfer Pad (Small, Medium, Large) Avance Transparent Film Avance Foam (2013), cited by 3
- K130852: Avance® Foam Abdominal Dressing Kit (2014), cited by 2
- K983184: Mepilex (1998), cited by 1

## Recent decisions
- K130852: Avance® Foam Abdominal Dressing Kit (Apr 14, 2014)
- K130040: Mepitel AG (Feb 12, 2014)
- K123892: Mepilex Transfer AG (Apr 5, 2013)
- K122132: Avance Foam Dressing Kit Incl. Transparent Film, Transfer Pad (Small, Medium, Large) Avance Transparent Film Avance Foam (Jan 17, 2013)
- K102923: Barrier N95 Particulate Respirator (Nov 19, 2010)
- K100029: Mepilex Border AG Dressing (Sep 15, 2010)
- K061554: Mepilex AG Absorbent Silicone-Coated Dressing (Jan 25, 2007)
- K062138: Powder Free Sterile Nitrile Examination Gloves, Blue; Powder Free Polychloroprene Sterile Examination Glove (Oct 5, 2006)

Source page: https://510kreport.com/company/molnlycke-health-care