Keeler Instruments, Inc.
Medical device manufacturer in Malvern, PA.
60510(k) clearances
0PMA approvals
1recalls
Device types
- HLI Ophthalmoscope, Ac-Powered 6
- HKX Tonometer, Ac-Powered 5
- HNN Knife, Ophthalmic 4
- HRM Microscope, Operating & Accessories… 4
- GZX Instrument, Microsurgical 4
- HLJ Ophthalmoscope, Battery-Powered 3
- HQF Laser, Ophthalmic 3
- HRN Unit, Cryophthalmic, Ac-Powered 3
- HPS Unit, Cryophthalmic 2
- HQA Unit, Cryotherapy, Ophthalmic 2
- HMP Pad, Eye 2
- HPQ Headlamp, Operating, Ac-Powered 2
- HNR Forceps, Ophthalmic 2
- HJO Biomicroscope, Slit-Lamp, Ac-Powered 2
- DWS Instruments, Surgical, Cardiovascular 1
- HOO Perimeter, Ac-Powered 1
- HNQ Hook, Ophthalmic 1
- FSP Loupe, Diagnostic/Surgical 1
- HRS Plate, Fixation, Bone 1
- HIT Tester, Color Vision 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K181143 | Keeler TonoCare TonometerHKX · Traditional | 02/08/2019SE |
| K112093 | Cryomatic Cryo Console, Disposable Cryo Probe, Disposable Probe AdapterHRN · Special | 12/08/2011SE |
| K093298 | Pulsair Intellipuff, Pulsair Desktop Model 2414-P-2001, 2417-P-2000HKX · Traditional | 12/10/2010SE |
| K100500 | PSL Classic Slit LampHJO · Traditional | 03/09/2010SE |
| K062412 | CryomaticHRN · Traditional | 11/06/2006SE |
| K060822 | Vantage Indirect OphthalmoscopeHLI · Special | 05/23/2006SE |
| K032087 | Keeler Wide Angle Ophthalmoscope Model 1130-P-5004HLJ · Traditional | 11/26/2003SE |
| K992954 | Keeler Cryo Master & ProbesHRN · Traditional | 12/21/1999SE |
| K990257 | Keeler Pulsair 3000 Non Contact TonometerHKX · Traditional | 03/25/1999SE |
| K973064 | Keeler Tearscope-PlusHJO · Traditional | 04/07/1998SE |
| K970029 | Keeler Spectra Indirect OphthalmoscopeHLJ · Traditional | 04/02/1997SE |
| K942180 | Keeler Multilase 3000HQF · Traditional | 11/22/1994SE |
| K942104 | Keeler Vantage Indirect OphthalmoscopeHLI · Traditional | 08/04/1994SE |
| K914956 | Keeler Konan Specular Microscope SP5500HRM · Traditional | 02/03/1992SE |
| K911721 | Keeler Pulsair Non Contact Tonometer, ModificationHKX · Traditional | 06/25/1991SE |
| K900111 | Keeler Konan Specular Microscope SP3300HLI · Traditional | 03/23/1990SE |
| K895213 | Microlase by Laser TrabeculoplastyHQF · Traditional | 10/31/1989SE |
| K893171 | Vista Streak Retinoscope (Ac-Powered)HKL · Traditional | 09/21/1989SE |
| K893173 | Vista Specialist Ophthalmoscope (Battery & Ac)HLI · Traditional | 06/05/1989SE |
| K893172 | Vista Ophthalmoscope (Battery and Ac-Powered)HLI · Traditional | 06/05/1989SE |
| K893170 | Vista Finoff Transilluminator (Ac-Powered)HJM · Traditional | 06/05/1989SE |
| K891610 | Henson Cfa 3000 Central Visual Field ScreenerHOD · Traditional | 06/05/1989SE |
| K890086 | Microlase 8 0 0 (Ophthalmic Laser)HQF · Traditional | 03/15/1989SE |
| K882772 | LQ1106 Ophthalmic Yag LaserGEX · Traditional | 08/26/1988SE |
| K874555 | Keeler Acu 22XT Ophthalmic Cryo UnitHPS · Traditional | 01/29/1988SE |
| K874411 | Donaldson Natural Eyepatch 'Patient Pak'HMP · Traditional | 01/27/1988SE |
| K873388 | Keeler Ctu Cryo SystemHPS · Traditional | 11/13/1987SE |
| K871369 | Various Types of: Keeler Magnatone 2 Stethoscopes:LDE · Traditional | 09/24/1987SE |
| K870750 | Keeler Pulsair Non Contact TonometerHKX · Traditional | 03/17/1987SE |
| K870203 | Keeler Lva System Multi-Cap Series LVA51-1/2/3/4/5HKK · Traditional | 02/12/1987SE |
| K864467 | Henson - Hamblin CFS 2000 Central Field ScreenHOO · Traditional | 12/15/1986SE |
| K864290 | Rk-M & Rk-Dk Diamond Knives with Measuring GaugeHNN · Traditional | 12/15/1986SE |
| K863992 | Thornton Titanium Forceps (Various Types)HNR · Traditional | 10/31/1986SE |
| K863991 | Thorton Titanium Needleholders(No,W Catch & StandHNR · Traditional | 10/31/1986SE |
| K863990 | Thornton Titanium Silver SpatulaHND · Traditional | 10/31/1986SE |
| K863989 | Thornton Titanium Speculum (Modified Barraquer)HNC · Traditional | 10/31/1986SE |
| K863988 | Thorton Titanium Hook Angled RightHNQ · Traditional | 10/31/1986SE |
| K861747 | Keeler Fiberoptic HeadlampHPQ · Traditional | 08/21/1986SE |
| K861746 | Keeler Dual LightsourceHPQ · Traditional | 08/21/1986SE |
| K861744 | Sapphire Knife BladeHNN · Traditional | 06/09/1986SE |
| K861748 | Ruby & Sapphire Blade HolderHNN · Traditional | 06/02/1986SE |
| K861749 | 3X Blue Panoramic Loupes 13.5 Working DistanceFSP · Traditional | 05/23/1986SE |
| K861745 | Vickers Ergomatic Microsurg Instru Cardiac SetDWS · Traditional | 05/13/1986SE |
| K860979 | Donaldson Natural EyepatchHMP · Traditional | 04/04/1986SE |
| K854422 | Series 25 Slimline Cryo ProbesHQA · Traditional | 12/30/1985SE |
| K854411 | Keeler-Compact Cryo SystemHQA · Traditional | 12/30/1985SE |
| K854440 | Modified Clinical Widefield Specular Microscope 50HRM · Traditional | 12/16/1985SE |
| K854256 | Keeler Amoils Surgical Astigometer · Traditional | 12/13/1985SE |
| K854244 | The Keeler All Pupil Indirect OphthalmoscopeHLI · Traditional | 11/12/1985SE |
| K853179 | Vickers Ergomatic Microsur Instru-Univ R O L HandGZX · Traditional | 11/07/1985SE |
| K853161 | The Vickers Standard Microsurgery SetGZX · Traditional | 11/07/1985SE |
| K853181 | Vickers Ergomatic Micros Instr-Fine R or L HandedGZX · Traditional | 10/28/1985SE |
| K853180 | Vickers Ergomatic Micros Instr-Long R or L HandedGZX · Traditional | 10/28/1985SE |
| K852150 | Clinical Widefield Specular Micriscope 500HRM · Traditional | 06/03/1985SE |
| K844323 | Konan Clinic Microscope CLM-100-150HRM · Traditional | 11/21/1984SE |
| K832843 | Oscar Colour Vision TesterHIT · Traditional | 01/04/1984SE |
| K832844 | Ruby Knives for Ophth. SurgeryHNN · Traditional | 09/29/1983SE |
| K832437 | Medic Lux Diagnostic SetsHLJ · Traditional | 08/16/1983SE |
| K811245 | Ophthalmic ScissorsHNF · Traditional | 07/31/1981SE |
| K811244 | Cryophthalmic UnitHRS · Traditional | 06/23/1981SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1132-2008 | Keeler All Pupil II Indirect Ophthalmoscope, Keeler Instruments, Inc., Broomall, PA 19008Good Manufacturing Practices (GMP) deficiencies may compromise the safety and effectiveness of the device.… | 01/08/2008Terminated |