Mayer Laboratories

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
19
Inspections
5
Compliance Actions
1

Recent 510(k) Clearances

K-NumberDeviceDate
K130345AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMINGAugust 1, 2013
K113686KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATEDMarch 6, 2012
K110325AQUA LUBEDecember 8, 2011
K001974EZ-ON CONDOMOctober 24, 2001
K946374KIMONO MICROTHINNovember 8, 1995
K946376MAXXSeptember 22, 1995
K943064KIMONO (CONDOMS)September 22, 1995
K925869SHEATHES, STERILE SHEATHESJanuary 6, 1994
K926049DIGITEX, DIGITEX HYPOALLERGENICJuly 22, 1993
K904375KIMONO PLUSNovember 26, 1990
K904453LABELLING MODIFICATION TO MAXX PLUSNovember 23, 1990
K904840ORION PLUS/MODIFICATIONNovember 20, 1990
K895530STANDARD CONDOMNovember 28, 1989
K884470KIMONO PLUS OTHERS (MULTIPLE) CONDOMSMarch 31, 1989
K884468SUPER MAXX OTHERS (MULTIPLE) CONDOMSMarch 31, 1989
K884469ORION PLUS W/NONOXYNOL-9 OTHERS (MULTIPLE) CONDOMSMarch 31, 1989
K872356CONDOMS (HOMBRE BLACK/BLACK SATIN/XT-12/ORION)April 6, 1988
K874851XL-4 PAGODA (CONDOMS)January 21, 1988
K872799KIMONO (CONDOMS)December 8, 1987