Molnlycke Health Care, Inc.
Molnlycke Health Care, Inc. holds FDA 510(k) medical device clearances, first cleared 1998, most recent 2006, with 4 FDA device recalls on record.
Top product codes for Molnlycke Health Care, Inc.
FDA recalls by Molnlycke Health Care, Inc.
- 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.
- Z-0417-2018 — 9x15" Medium Utility Positioner with Cover
- Z-0416-2018 — 7x10" Small Utility Positioner with Cover
- Z-2110-2017 — Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Molnlycke Health Care, Inc.
- K062138 — POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPRENE STERILE EXAMINATION GLOVE
- K051625 — BARRIER SURGICAL DRAPES
- K000902 — KLINIDRAPE REINFORCED SURGICAL GOWNS
- K000901 — KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD PROTECTION
- K000906 — KLINIDRAPE SURGICAL DRAPES
- K984371 — MEPITEL NON ADHERENT SILICONE DRESSING
- K984370 — HYPERGEL 20% HYPERTONIC SALINE GEL
- K984368 — NORMLGEL 0.9% ISOTONIC SALINE GEL
- K983554 — ALLDRESS, ABSORBENT FILM DRESSING
- K983184 — MEPILEX
Data sourced from openFDA. This site is unofficial and independent of the FDA.