Panels › Ophthalmic › Product code HLI · Class 2
Ophthalmoscope, Ac-Powered
Regulation 886.1570
0510(k)s in 12 months (87 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in HLI
| Company | 510(k)s | Recalls |
|---|---|---|
| Optovue, Inc. | 7 | 4 |
| Carl Zeiss Meditec, Inc. | 7 | 1 |
| Keeler Instruments, Inc. | 6 | 1 |
| Neitz Instruments Company, Ltd. | 7 | 0 |
| Heidelberg Engineering | 5 | 0 |
| Talia Technology , Ltd. | 5 | 0 |
| Welch Allyn, Inc. | 5 | 0 |
| Woodlyn, Inc. | 5 | 0 |
| American Medical Optics | 3 | 0 |
| Bioptigen, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 4, 1994 | K942104 | KEELER VANTAGE INDIRECT OPHTHALMOSCOPE Keeler Instruments, Inc. | HLI |
| Jul 18, 1994 | K941705 | NERVE FIBER ANALYZER Carl Zeiss Meditec, Inc. | HLI |
| Feb 22, 1994 | K935988 | R&D BATTERIES # 5615, 5234, 5097 R & D Batteries, Inc. | HLI |
| Jun 21, 1993 | K930023 | MODEL #12000 BINOCULAR INDERECT OPHTHALMOSCOPE Welch Allyn, Inc. | HLI |
| Mar 26, 1993 | K923742 | TOPOGRAPHIC SCANNING SYSTEM TOPSS Carl Zeiss Meditec, Inc. | HLI |
| Oct 27, 1992 | K921163 | REGALTECH MAXISCOPE Regaltech Pty. , Ltd., AU | HLI |
| Jan 6, 1992 | K914484 | LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE Hgm Medical Laser Systems, Inc. | HLI |
| Dec 23, 1991 | K912581 | ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO) Carl Zeiss, Inc. | HLI |
| Oct 23, 1991 | K912397 | PROFESSIONAL INDIRECT OPHTHALMOSCOPE Clement Clarke, Inc., GB | HLI |
| Oct 9, 1991 | K913118 | GLAUCOMA-SCOPE Ophthalmic Imaging Systems | HLI |
| Sep 27, 1991 | K912891 | HEIDELBERG RETINA TOMOGRAPH Heidelberg Engineering | HLI |
| Mar 23, 1990 | K900111 | KEELER KONAN SPECULAR MICROSCOPE SP3300 Keeler Instruments, Inc. | HLI |
| Sep 11, 1989 | K895010 | MENTOR SPECTACLE BINOCULAR INDIRECT OPHTHALMOSCOPE Mentor O & O, Inc. | HLI |
| Jun 5, 1989 | K893173 | VISTA SPECIALIST OPHTHALMOSCOPE (BATTERY & AC) Keeler Instruments, Inc. | HLI |
| Jun 5, 1989 | K893172 | VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED) Keeler Instruments, Inc. | HLI |
| Jan 24, 1989 | K882517 | RODENSTOCK SCANNING LASER OPHTHALMOSCOPE Rodenstock Instrument Corp. | HLI |
| Sep 6, 1988 | K881984 | EOL, MODEL LIO Eol, Inc. | HLI |
| Jun 10, 1987 | K871268 | RODENSTOCK SCANNING LASER OPHTHALMOSCOPE G. Rodenstock Instrumente GmbH, DE | HLI |
| Nov 12, 1985 | K854244 | THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPE Keeler Instruments, Inc. | HLI |
| May 1, 1985 | K851264 | AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS American Medical Optics | HLI |
| May 1, 1985 | K851263 | AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOP American Medical Optics | HLI |
| Apr 30, 1985 | K851262 | AMER. MEDICAL OPTICAL BINOCULAR INDIRECT OPHTHALMA American Medical Optics | HLI |
| Feb 15, 1985 | K844971 | MONOCULAR DIRECT OPHTHALMOSCOPE Nidek, Inc. | HLI |
| Feb 15, 1985 | K843597 | NIDEK MONOCULAR INDIRECT OPHTHALMOSCOPE Nidek, Inc. | HLI |
| Feb 15, 1985 | K843596 | NIDEK-BINOCULAR INDIRECT OPHTHALMOSCOPE Nidek, Inc. | HLI |
| Dec 19, 1984 | K844054 | CANON AUTO KERATOMETER K-1 Canon USA, Inc. | HLI |
| Dec 11, 1984 | K843812 | WOODLYN CLASSIC CATARACT ACUITY TEST Woodlyn, Inc. | HLI |
| Nov 21, 1984 | K843304 | BINOCULAR INDIRECT OPHTHALMOSCOPE Mentor O & O, Inc. | HLI |
| Nov 21, 1984 | K843099 | MAMIYA SLIT LAMP P-1 Okada Corp. | HLI |
| Aug 7, 1984 | K841767 | WOODLYN CLASSIC KERATOMETER Woodlyn, Inc. | HLI |
| Aug 7, 1984 | K841764 | WOODLYN CLASSIC JAVAL OPHTHALMOMETER Woodlyn, Inc. | HLI |
| Aug 7, 1984 | K841761 | WOODLYN CLASSIC SLIT LAMP HSSL-CL Woodlyn, Inc. | HLI |
| Aug 2, 1984 | K841763 | WOODLYN SLIT LAMP HSSL-EC Woodlyn, Inc. | HLI |
| Aug 10, 1982 | K822104 | ALCON INDIRECT OPHTHALMOSCOPE Alcon Laboratories | HLI |
| Dec 11, 1979 | K791510 | BLUE FIELD ENTOPTOSCOPE BFE100 Medical Instrument Research Assoc., Inc. | HLI |
| Dec 13, 1977 | K772214 | OPHTHALMOSCOPE, BINOCULAR, INDIRECT Varian Assoc., Inc. | HLI |
| May 6, 1977 | K770768 | OPHTHALMOSCOPE, MODEL #11100 Welch Allyn, Inc. | HLI |
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