Keeler Instruments, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
60
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K181143Keeler TonoCare TonometerFebruary 8, 2019
K112093CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTERDecember 8, 2011
K093298PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000December 10, 2010
K100500PSL CLASSIC SLIT LAMPMarch 9, 2010
K062412CRYOMATICNovember 6, 2006
K060822VANTAGE INDIRECT OPHTHALMOSCOPEMay 23, 2006
K032087KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004November 26, 2003
K992954KEELER CRYO MASTER & PROBESDecember 21, 1999
K990257KEELER PULSAIR 3000 NON CONTACT TONOMETERMarch 25, 1999
K973064KEELER TEARSCOPE-PLUSApril 7, 1998
K970029KEELER SPECTRA INDIRECT OPHTHALMOSCOPEApril 2, 1997
K942180KEELER MULTILASE 3000November 22, 1994
K942104KEELER VANTAGE INDIRECT OPHTHALMOSCOPEAugust 4, 1994
K914956KEELER KONAN SPECULAR MICROSCOPE SP5500February 3, 1992
K911721KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATIONJune 25, 1991
K900111KEELER KONAN SPECULAR MICROSCOPE SP3300March 23, 1990
K895213MICROLASE BY LASER TRABECULOPLASTYOctober 31, 1989
K893171VISTA STREAK RETINOSCOPE (AC-POWERED)September 21, 1989
K891610HENSON CFA 3000 CENTRAL VISUAL FIELD SCREENERJune 5, 1989
K893172VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED)June 5, 1989