Molnlycke Health Care
Molndal Vastra Gotaland, SE
MOLNLYCKE HEALTH CARE appears in FDA device records in Molndal Vastra Gotaland, SE. FDA records list 19 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 6 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 19 510(k) clearances for Molnlycke Health Care between 1998 and 2014. The busiest year on record is 1999, with 3. The most recent is 2014, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 2 |
| 1999 | 3 |
| 2000 | 3 |
| 2003 | 1 |
| 2005 | 2 |
| 2006 | 1 |
| 2007 | 1 |
| 2010 | 2 |
| 2013 | 2 |
| 2014 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K130852 | AVANCE® FOAM ABDOMINAL DRESSING KIT | OXJ | Substantially Equivalent | |
| K130040 | MEPITEL AG | FRO | Substantially Equivalent | |
| K123892 | MEPILEX TRANSFER AG | FRO | Substantially Equivalent | |
| K122132 | AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAM | OMP | Substantially Equivalent | |
| K102923 | BARRIER N95 PARTICULATE RESPIRATOR | MSH | Substantially Equivalent | |
| K100029 | MEPILEX BORDER AG DRESSING | FRO | Substantially Equivalent | |
| K061554 | MEPILEX AG ABSORBENT SILICONE-COATED DRESSING | FRO | Substantially Equivalent | |
| K062138 | POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPRENE STERILE EXAMINATION GLOVE | LZA | Substantially Equivalent | |
| K051625 | BARRIER SURGICAL DRAPES | KKX | Substantially Equivalent | |
| K050786 | BARRIER SURGICAL GOWNS | FYA | Substantially Equivalent | |
| K031131 | KLINIDRAPE SURGICAL DRAPES | KKX | Substantially Equivalent | |
| K000902 | KLINIDRAPE REINFORCED SURGICAL GOWNS | FYA | Substantially Equivalent | |
| K000901 | KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD PROTECTION | FYA | Substantially Equivalent | |
| K000906 | KLINIDRAPE SURGICAL DRAPES | KKX | Substantially Equivalent | |
| K984371 | MEPITEL NON ADHERENT SILICONE DRESSING | MGP | Substantially Equivalent | |
| K984370 | HYPERGEL 20% HYPERTONIC SALINE GEL | MGQ | Substantially Equivalent | |
| K984368 | NORMLGEL 0.9% ISOTONIC SALINE GEL | MGQ | Substantially Equivalent | |
| K983554 | ALLDRESS, ABSORBENT FILM DRESSING | KMF | Substantially Equivalent for Some Indications | |
| K983184 | MEPILEX | MGP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8020673 | 2819 | MOLNLYCKE HEALTH CARE | TUBITON HOUSE, OLDHAM OL1 3HS GB | 2026 | |
| 3007048057 | 3007048057 | Molnlycke Health Care AB | Entreprenorsstraket 21, Molndal Vastra Gotaland SE-431 53 SE | 2026 | and 10 more, listed in full below |
| 3007605720 | 3007605720 | Molnlycke Health Care Oy | Saimaankatu 6 PO Box 76, Mikkeli Etela-Savo FI-50101 FI | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FQMBandage, Elastic
- KMFBandage, Liquid
- FYFCap, Surgical
- FMRDevice, Transfer, Patient, Manual
- KKXDrape, Surgical, Antimicrobial
- MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
- MGPDressing, Wound And Burn, Occlusive
- FRODressing, Wound, Drug
- NACDressing, Wound, Hydrophilic
- NADDressing, Wound, Occlusive
- MDAElastomer, Silicone, For Scar Management
- FYAGown, Surgical
- LYYLatex Patient Examination Glove
- FNGLift, Patient, Ac-Powered
- FSALift, Patient, Non-Ac-Powered
- FXXMask, Surgical
- IKYMattress, Flotation Therapy, Non-Powered
- OXJMesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects
- OMPNegative Pressure Wound Therapy Powered Suction Pump
- LZAPolymer Patient Examination Glove
- FMPProtector, Skin Pressure
- OPHRadiation Attenuating Medical Glove
- MSHRespirator, Surgical
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- KGOSurgeon'S Gloves
- KGXTape And Bandage, Adhesive
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1243-2019 | EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03; b. EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated, Part Number: 131704-03; c. EZ Derm 2 x 2 (5 x 5 cm) Non-Perforated, Part Number: 131705-03; d. EZ Derm 3 x 48 (8 x 122 cm) Perforated, Part Number: 131710-03; e. EZ Derm 3 x 24 (8 x 61 cm) Perforated, Part Number: 131711-03; f. EZ Derm 3 x 12 (8 x 30 cm) Perforated, Part Number: 131712-03; g. EZ Derm 3 x 4 (8 x 10 cm) Perforated, Part Number: 131713-03; h. EZ Derm 7 x 18 (17 x 46 cm) Perforated, Part Number: 131714-03; i. EZ Derm 2 x 2 (5 x 5 cm) Perforated. Part Number: 131715-03 Product Usage: EZ Derm is a porcine derived xenograft in which the collagen has been cross linked with an aldehyde. EZ Derm (porcine xenograft) can be used for partial thickness skin loss injuries. Use of EZ Derm for burns, donor sites and chronic vascular ulcers reduces pain and fluid loss. EZ Derm can also be used as a temporary cover, or test graft, prior to auto grafting and as a protective covering over perforated auto grafts. | Intermittent heat seal failures on the outer pouch of some EZ Derm products. | Class II | Terminated | |
| Z-0417-2018 | 9x15" Medium Utility Positioner with Cover | Products may not meet specifications due to possible presence of metal shavings. | Class II | Terminated | |
| Z-0416-2018 | 7x10" Small Utility Positioner with Cover | Products may not meet specifications due to possible presence of metal shavings. | Class II | Terminated | |
| Z-2110-2017 | Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts' | Sterilization validation failure. | Class II | Open, Classified | |
| Z-1219-2007 | Biogel Skinsense Polyisoprene Surgical Gloves, Non-Latex, Sterile, (Size 8) Made in Malaysia | Sterility compromised (package integrity): The primary packaging for a portion of the lot may contain gloves that were not sealed properly. | Terminated | ||
| Z-1137-03 | Barrier Hip Sheet with Side Pockets | pouch may tear which could result in contamination of sterile field | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain