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Molnlycke Health Care, Inc

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
19
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1243-2019Class IIEZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, PMarch 26, 2019
Z-0417-2018Class II9x15" Medium Utility Positioner with CoverJuly 26, 2017
Z-0416-2018Class II7x10" Small Utility Positioner with CoverJuly 26, 2017
Z-2110-2017Class IIBrennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'April 24, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K130852AVANCE® FOAM ABDOMINAL DRESSING KITApril 14, 2014
K130040MEPITEL AGFebruary 12, 2014
K123892MEPILEX TRANSFER AGApril 5, 2013
K122132AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARJanuary 17, 2013
K102923BARRIER N95 PARTICULATE RESPIRATORNovember 19, 2010
K100029MEPILEX BORDER AG DRESSINGSeptember 15, 2010
K061554MEPILEX AG ABSORBENT SILICONE-COATED DRESSINGJanuary 25, 2007
K062138POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPRENE STERILE EXAMINATIOOctober 5, 2006
K051625BARRIER SURGICAL DRAPESJuly 14, 2005
K050786BARRIER SURGICAL GOWNSMay 9, 2005
K031131KLINIDRAPE SURGICAL DRAPESJune 10, 2003
K000902KLINIDRAPE REINFORCED SURGICAL GOWNSJuly 11, 2000
K000901KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD PROTECTIONJuly 5, 2000
K000906KLINIDRAPE SURGICAL DRAPESJune 23, 2000
K984371MEPITEL NON ADHERENT SILICONE DRESSINGMarch 3, 1999
K984370HYPERGEL 20% HYPERTONIC SALINE GELMarch 1, 1999
K984368NORMLGEL 0.9% ISOTONIC SALINE GELFebruary 22, 1999
K983554ALLDRESS, ABSORBENT FILM DRESSINGNovember 10, 1998
K983184MEPILEXOctober 28, 1998