Mira, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
21
Inspections
9
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K951728SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPEMarch 19, 1997
K950806SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTSJune 5, 1996
K941495RETURN PATH DIATHERMY HANDLEJuly 15, 1994
K933527MODIFICATION OF ANTERIOR SEGMENT ELECTRODESJanuary 25, 1994
K923629OPHTHALMIC TRICHIASIS PROBEOctober 19, 1992
K894248CONVERTER SYSTEMFebruary 27, 1990
K891601POWER OPERATED AND CONTROLLED VITREOUS SCISSORSMay 23, 1989
K890448LIGHT SOURCE, ENDOSCOP, XENON ARCMay 8, 1989
K863246MIRALITEOctober 31, 1986
K863591ENDOPHOTOCOAGULATION PROBEOctober 10, 1986
K855105SIMMONS SHELLMarch 31, 1986
K854869INTRAOCULAR FORCEPS & SCISSORSMarch 5, 1986
K855215AIR/FLUID EXCHANGE SYSTEMFebruary 27, 1986
K854870INTRAOCULAR ELECTROMAGNETFebruary 19, 1986
K854872VFI/VFE SYSTEM IIFebruary 13, 1986
K854871MICRO SURGICAL SYSTEMFebruary 7, 1986
K854868I/A - VFE SYSTEM IIFebruary 7, 1986
K854873INTRAOCULAR PRESSURE REDUCERFebruary 4, 1986
K854288OPHALMIC LASER PHOTOCOAGULATORNovember 12, 1985
K853890OPHTHALMIC LASER PHOTOCOAGULATORNovember 12, 1985