Medical Device Manufacturer · US , Mchenry , IL

Keeler Instruments, Inc.

60 submissions · 60 cleared · Since 1981
60
Total
60
Cleared
0
Denied

Keeler Instruments, Inc. — FDA 510(k) Submissions

Keeler Instruments, Inc. has submitted 60 FDA 510(k) premarket notifications since 1981, of which 60 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Ophthalmoscope, Ac-powered, Tonometer, Ac-powered, Knife, Ophthalmic, Microscope, Operating & Accessories, Ac-powered, Ophthalmic, Instrument, Microsurgical . Use the specialty filter in the sidebar to narrow results.

60 devices
1–25 of 60
Keeler TonoCare Tonometer
K181143 · HKX Tonometer, Ac-powered · Ophthalmic
Feb 2019 283d
CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER
K112093 · HRN Unit, Cryophthalmic,... · Ophthalmic
Dec 2011 139d
PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000
K093298 · HKX Tonometer, Ac-powered · Ophthalmic
Dec 2010 415d
PSL CLASSIC SLIT LAMP
K100500 · HJO Biomicroscope, Slit-lamp,... · Ophthalmic
Mar 2010 15d
CRYOMATIC
K062412 · HRN Unit, Cryophthalmic,... · Ophthalmic
Nov 2006 81d
VANTAGE INDIRECT OPHTHALMOSCOPE
K060822 · HLI Ophthalmoscope, Ac-powered · Ophthalmic
May 2006 57d
KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004
K032087 · HLJ Ophthalmoscope,... · Ophthalmic
Nov 2003 142d
KEELER CRYO MASTER & PROBES
K992954 · HRN Unit, Cryophthalmic,... · Ophthalmic
Dec 1999 111d
KEELER PULSAIR 3000 NON CONTACT TONOMETER
K990257 · HKX Tonometer, Ac-powered · Ophthalmic
Mar 1999 57d
KEELER TEARSCOPE-PLUS
K973064 · HJO Biomicroscope, Slit-lamp,... · Ophthalmic
Apr 1998 232d
KEELER SPECTRA INDIRECT OPHTHALMOSCOPE
K970029 · HLJ Ophthalmoscope,... · Ophthalmic
Apr 1997 89d
KEELER MULTILASE 3000
K942180 · HQF Laser, Ophthalmic · Ophthalmic
Nov 1994 202d
KEELER VANTAGE INDIRECT OPHTHALMOSCOPE
K942104 · HLI Ophthalmoscope, Ac-powered · Ophthalmic
Aug 1994 94d
KEELER KONAN SPECULAR MICROSCOPE SP5500
K914956 · HRM Microscope, Operating &... · General & Plastic Surgery
Feb 1992 90d
KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION
K911721 · HKX Tonometer, Ac-powered · Ophthalmic
Jun 1991 69d
KEELER KONAN SPECULAR MICROSCOPE SP3300
K900111 · HLI Ophthalmoscope, Ac-powered · Ophthalmic
Mar 1990 73d
MICROLASE BY LASER TRABECULOPLASTY
K895213 · HQF Laser, Ophthalmic · Ophthalmic
Oct 1989 74d
VISTA STREAK RETINOSCOPE (AC-POWERED)
K893171 · HKL Retinoscope, Ac-powered · Ophthalmic
Sep 1989 149d
HENSON CFA 3000 CENTRAL VISUAL FIELD SCREENER
K891610 · HOD Clamp, Eyelid, Ophthalmic · Ophthalmic
Jun 1989 77d
VISTA FINOFF TRANSILLUMINATOR (AC-POWERED)
K893170 · HJM Transilluminator, Ac-powered · Ophthalmic
Jun 1989 41d
VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED)
K893172 · HLI Ophthalmoscope, Ac-powered · Ophthalmic
Jun 1989 41d
VISTA SPECIALIST OPHTHALMOSCOPE (BATTERY & AC)
K893173 · HLI Ophthalmoscope, Ac-powered · Ophthalmic
Jun 1989 41d
MICROLASE 8 0 0 (OPHTHALMIC LASER)
K890086 · HQF Laser, Ophthalmic · Ophthalmic
Mar 1989 64d
LQ1106 OPHTHALMIC YAG LASER
K882772 · GEX Powered Laser Surgical... · General & Plastic Surgery
Aug 1988 51d
KEELER ACU 22XT OPHTHALMIC CRYO UNIT
K874555 · HPS Unit, Cryophthalmic · Ophthalmic
Jan 1988 86d
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