Company · US

Mayer Laboratories

FDA 510(k) clearances and medical device recalls filed under this name, 1987 to 2026. Name variants (Inc, Corp, punctuation) are merged.

20510(k) clearances (1 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
HIS	Condom	14
MOL	Condom, Synthetic	2
NUC	Lubricant, Personal	2
ITX	Transducer, Ultrasonic, Diagnostic	1
LYY	Latex Patient Examination Glove	1

Decided	510(k)	Device and applicant	Code
Mar 30, 2026	K252158	Sagami Original 002 Polyurethane Male Condom Mayer Laboratories	MOL
Aug 1, 2013	K130345	AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMING Mayer Laboratories, Inc.	NUC
Mar 6, 2012	K113686	KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED Mayer Laboratories, Inc.	HIS
Dec 8, 2011	K110325	AQUA LUBE Mayer Laboratories, Inc.	NUC
Oct 24, 2001	K001974	EZ-ON CONDOM Mayer Laboratories	MOL
Nov 8, 1995	K946374	KIMONO MICROTHIN Mayer Laboratories	HIS
Sep 22, 1995	K946376	MAXX Mayer Laboratories	HIS
Sep 22, 1995	K943064	KIMONO (CONDOMS) Mayer Laboratories	HIS
Jan 6, 1994	K925869	SHEATHES, STERILE SHEATHES Mayer Laboratories	ITX
Jul 22, 1993	K926049	DIGITEX, DIGITEX HYPOALLERGENIC Mayer Laboratories	LYY
Nov 26, 1990	K904375	KIMONO PLUS Mayer Laboratories	HIS
Nov 23, 1990	K904453	LABELLING MODIFICATION TO MAXX PLUS Mayer Laboratories	HIS
Nov 20, 1990	K904840	ORION PLUS/MODIFICATION Mayer Laboratories	HIS
Nov 28, 1989	K895530	STANDARD CONDOM Mayer Laboratories	HIS
Mar 31, 1989	K884470	KIMONO PLUS OTHERS (MULTIPLE) CONDOMS Mayer Laboratories	HIS
Mar 31, 1989	K884469	ORION PLUS W/NONOXYNOL-9 OTHERS (MULTIPLE) CONDOMS Mayer Laboratories	HIS
Mar 31, 1989	K884468	SUPER MAXX OTHERS (MULTIPLE) CONDOMS Mayer Laboratories	HIS
Apr 6, 1988	K872356	CONDOMS (HOMBRE BLACK/BLACK SATIN/XT-12/ORION) Mayer Laboratories	HIS
Jan 21, 1988	K874851	XL-4 PAGODA (CONDOMS) Mayer Laboratories	HIS
Dec 8, 1987	K872799	KIMONO (CONDOMS) Mayer Laboratories	HIS

Date	Firm and product	Code	Linked 510(k)
No recalls in this window.