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Carl Zeiss, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
44
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K013402VISULAS 532SNovember 14, 2001
K003885VISULAS YAG IIFebruary 22, 2001
K993357IOLMASTERMarch 20, 2000
K983868OPMI TWINER SURGICAL MICROSCOPEJanuary 29, 1999
K965139SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEMApril 23, 1997
K961380CPC PROBEMarch 17, 1997
K961171HUMPHREY OCT SCANNERJune 21, 1996
K954167HUMPHREY FIELD ANALYZER (HFA II)November 24, 1995
K952894VISULINK 900 ARGONAugust 14, 1995
K950985ZEISS ENDOLIVE STERO ENDOSCOPEMarch 29, 1995
K931478ZEISS OPMI L STEREO-LAPAROSCOPESeptember 28, 1994
K942233MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEMJuly 1, 1994
K936198ZEISS SUPERLUX HIGH-INTENSITY LIGHT SOURCESApril 6, 1994
K932376ZEISS OPMILAS 144 SURGICAL LASERSDecember 14, 1993
K926452ZEISS VISULAS YAG II LASERNovember 22, 1993
K933322ZEISS OPMILAS 144 SURGICAL LASERSOctober 15, 1993
K925642ZEISS DIODE-PUMPED SOLID STATE LASERSeptember 13, 1993
K925641ZEISS 20 SL SLIT-LAMP & MECHANICAL MICROMANIPULATRSeptember 9, 1993
K924588ZEISS LASER INDIRECT OPHTHALMOSCOPEJuly 9, 1993
K923274ZEISS VISULAS DIODE LASERApril 5, 1993