ClearanceBrief
Company ยท US

Keeler Instruments, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 2019. Name variants (Inc, Corp, punctuation) are merged.

60510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)

Product codes

CodeDeviceRecords
HLIOphthalmoscope, Ac-Powered7
HKXTonometer, Ac-Powered5
GZXInstrument, Microsurgical4
HNNKnife, Ophthalmic4
HRMMicroscope, Operating & Accessories, Ac-Powered, Ophthalmic4
HLJOphthalmoscope, Battery-Powered3
HQFLaser, Ophthalmic3
HRNUnit, Cryophthalmic, Ac-Powered3
HJOBiomicroscope, Slit-Lamp, Ac-Powered2
HMPPad, Eye2
HNRForceps, Ophthalmic2
HPQHeadlamp, Operating, Ac-Powered2
HPSUnit, Cryophthalmic2
HQAUnit, Cryotherapy, Ophthalmic2
DWSInstruments, Surgical, Cardiovascular1
FSPLoupe, Diagnostic/Surgical1
GEXPowered Laser Surgical Instrument1
HITTester, Color Vision1
HJMTransilluminator, Ac-Powered1
HKKTelescope, Spectacle, Low-Vision1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Feb 8, 2019K181143Keeler TonoCare Tonometer
Keeler Instruments, Inc.
HKX
Dec 8, 2011K112093CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER
Keeler Instruments, Inc.
HRN
Dec 10, 2010K093298PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000
Keeler Instruments, Inc.
HKX
Mar 9, 2010K100500PSL CLASSIC SLIT LAMP
Keeler Instruments, Inc.
HJO
Nov 6, 2006K062412CRYOMATIC
Keeler Instruments, Inc.
HRN
May 23, 2006K060822VANTAGE INDIRECT OPHTHALMOSCOPE
Keeler Instruments, Inc.
HLI
Nov 26, 2003K032087KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004
Keeler Instruments, Inc.
HLJ
Dec 21, 1999K992954KEELER CRYO MASTER & PROBES
Keeler Instruments, Inc.
HRN
Mar 25, 1999K990257KEELER PULSAIR 3000 NON CONTACT TONOMETER
Keeler Instruments, Inc.
HKX
Apr 7, 1998K973064KEELER TEARSCOPE-PLUS
Keeler Instruments, Inc.
HJO
Apr 2, 1997K970029KEELER SPECTRA INDIRECT OPHTHALMOSCOPE
Keeler Instruments, Inc.
HLJ
Nov 22, 1994K942180KEELER MULTILASE 3000
Keeler Instruments, Inc.
HQF
Aug 4, 1994K942104KEELER VANTAGE INDIRECT OPHTHALMOSCOPE
Keeler Instruments, Inc.
HLI
Feb 3, 1992K914956KEELER KONAN SPECULAR MICROSCOPE SP5500
Keeler Instruments, Inc.
HRM
Jun 25, 1991K911721KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION
Keeler Instruments, Inc.
HKX
Mar 23, 1990K900111KEELER KONAN SPECULAR MICROSCOPE SP3300
Keeler Instruments, Inc.
HLI
Oct 31, 1989K895213MICROLASE BY LASER TRABECULOPLASTY
Keeler Instruments, Inc.
HQF
Sep 21, 1989K893171VISTA STREAK RETINOSCOPE (AC-POWERED)
Keeler Instruments, Inc.
HKL
Jun 5, 1989K893173VISTA SPECIALIST OPHTHALMOSCOPE (BATTERY & AC)
Keeler Instruments, Inc.
HLI
Jun 5, 1989K893172VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED)
Keeler Instruments, Inc.
HLI
Jun 5, 1989K893170VISTA FINOFF TRANSILLUMINATOR (AC-POWERED)
Keeler Instruments, Inc.
HJM
Jun 5, 1989K891610HENSON CFA 3000 CENTRAL VISUAL FIELD SCREENER
Keeler Instruments, Inc.
HOD
Mar 15, 1989K890086MICROLASE 8 0 0 (OPHTHALMIC LASER)
Keeler Instruments, Inc.
HQF
Aug 26, 1988K882772LQ1106 OPHTHALMIC YAG LASER
Keeler Instruments, Inc.
GEX
Jan 29, 1988K874555KEELER ACU 22XT OPHTHALMIC CRYO UNIT
Keeler Instruments, Inc.
HPS
Jan 27, 1988K874411DONALDSON NATURAL EYEPATCH 'PATIENT PAK'
Keeler Instruments, Inc.
HMP
Nov 13, 1987K873388KEELER CTU CRYO SYSTEM
Keeler Instruments, Inc.
HPS
Sep 24, 1987K871369VARIOUS TYPES OF: KEELER MAGNATONE 2 STETHOSCOPES:
Keeler Instruments, Inc.
LDE
Mar 17, 1987K870750KEELER PULSAIR NON CONTACT TONOMETER
Keeler Instruments, Inc.
HKX
Feb 12, 1987K870203KEELER LVA SYSTEM MULTI-CAP SERIES LVA51-1/2/3/4/5
Keeler Instruments, Inc.
HKK
Dec 15, 1986K864467HENSON - HAMBLIN CFS 2000 CENTRAL FIELD SCREEN
Keeler Instruments, Inc.
HOO
Dec 15, 1986K864290RK-M & RK-DK DIAMOND KNIVES WITH MEASURING GAUGE
Keeler Instruments, Inc.
HNN
Oct 31, 1986K863992THORNTON TITANIUM FORCEPS (VARIOUS TYPES)
Keeler Instruments, Inc.
HNR
Oct 31, 1986K863991THORTON TITANIUM NEEDLEHOLDERS(NO,W CATCH & STAND
Keeler Instruments, Inc.
HNR
Oct 31, 1986K863990THORNTON TITANIUM SILVER SPATULA
Keeler Instruments, Inc.
HND
Oct 31, 1986K863989THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER)
Keeler Instruments, Inc.
HNC
Oct 31, 1986K863988THORTON TITANIUM HOOK ANGLED RIGHT
Keeler Instruments, Inc.
HNQ
Aug 21, 1986K861747KEELER FIBEROPTIC HEADLAMP
Keeler Instruments, Inc.
HPQ
Aug 21, 1986K861746KEELER DUAL LIGHTSOURCE
Keeler Instruments, Inc.
HPQ
Jun 9, 1986K861744SAPPHIRE KNIFE BLADE
Keeler Instruments, Inc.
HNN
Jun 2, 1986K861748RUBY & SAPPHIRE BLADE HOLDER
Keeler Instruments, Inc.
HNN
May 23, 1986K8617493X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE
Keeler Instruments, Inc.
FSP
May 13, 1986K861745VICKERS ERGOMATIC MICROSURG INSTRU CARDIAC SET
Keeler Instruments, Inc.
DWS
Apr 4, 1986K860979DONALDSON NATURAL EYEPATCH
Keeler Instruments, Inc.
HMP
Dec 30, 1985K854422SERIES 25 SLIMLINE CRYO PROBES
Keeler Instruments, Inc.
HQA
Dec 30, 1985K854411KEELER-COMPACT CRYO SYSTEM
Keeler Instruments, Inc.
HQA
Dec 16, 1985K854440MODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50
Keeler Instruments, Inc.
HRM
Dec 13, 1985K854256KEELER AMOILS SURGICAL ASTIGOMETER
Keeler Instruments, Inc.
Nov 12, 1985K854244THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPE
Keeler Instruments, Inc.
HLI
Nov 7, 1985K853179VICKERS ERGOMATIC MICROSUR INSTRU-UNIV R O L HAND
Keeler Instruments, Inc.
GZX

Newest 50 of 60.

Latest recalls

DateFirm and productCodeLinked 510(k)
May 22, 2008Keeler Instruments Inc
Keeler All Pupil II Indirect Ophthalmoscope, Keeler Instruments, Inc., Broomall, PA 19008
Terminated		 HLIK854244
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