HLJ · Class II · 21 CFR 886.1570

FDA Product Code HLJ: Ophthalmoscope, Battery-powered

Leading manufacturers include Rudolf Riester GmbH & Co. KG, Neitz Instruments Company, Ltd. and R & D Batteries, Inc..

47
Total
47
Cleared
123d
Avg days
1976
Since

FDA 510(k) Cleared Ophthalmoscope, Battery-powered Devices (Product Code HLJ)

47 devices
1–24 of 47
Cleared Nov 19, 2010
OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS
K093495
American Diagnostic Corp.
Ophthalmic · 374d
Cleared Nov 26, 2003
KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004
K032087
Keeler Instruments, Inc.
Ophthalmic · 142d
Cleared Jul 03, 1997
MS401097-17,MS722-K,MS720,MS721,MS722
K962767
Alexander Mfg. Co.
Ophthalmic · 352d
Cleared Apr 02, 1997
KEELER SPECTRA INDIRECT OPHTHALMOSCOPE
K970029
Keeler Instruments, Inc.
Ophthalmic · 89d
Cleared Jul 24, 1995
RI-FORMER WALL MODEL 2,5 V/220 V OR 110 V 3,5 V/220 V OR 110 V, RI-FORMER ANAESTHETIC MODEL 2,5 V/220 V OR 110 C 3,5 V/V
K950914
Rudolf Riester GmbH & Co. KG
Ophthalmic · 151d
Cleared Mar 28, 1995
HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134
K950797
Neitz Instruments Company, Ltd.
Ophthalmic · 35d
Cleared Mar 22, 1995
HALOGEN DIAGNOSTIC SET BX A - 12345
K950796
Neitz Instruments Company, Ltd.
Ophthalmic · 29d
Cleared Jan 17, 1995
RI-SCOPE S OTOSCOPE
K945640
Rudolf Riester GmbH & Co. KG
Ophthalmic · 62d
Cleared Aug 05, 1994
NEITZ HALOGEN OPHTHALMOSCOPE BXA-13A
K942717
Neitz Instruments Company, Ltd.
Ophthalmic · 57d
Cleared Aug 05, 1994
NEITZ HALOGEN POCKET OPHTHALMOSCOPE A-JR
K942719
Neitz Instruments Company, Ltd.
Ophthalmic · 57d
Cleared Aug 05, 1994
NEITZ HALOGEN OPHTHALMOSCOPE BXA-13
K942721
Neitz Instruments Company, Ltd.
Ophthalmic · 57d
Cleared Jun 03, 1994
R&D BATTERIES, PART NOS. 5135, 5097, 5444, AND 5502
K942034
R & D Batteries, Inc.
Ophthalmic · 36d
Cleared Feb 22, 1994
REPLACEMENT BATTERIES PART NO. 5098,5135, 5097
K936018
R & D Batteries, Inc.
Ophthalmic · 68d
Cleared Feb 22, 1994
R & D BATTERIES
K936104
R & D Batteries, Inc.
Ophthalmic · 62d
Cleared Dec 03, 1993
DE LUXE
K925755
Rudolf Riester GmbH & Co. KG
Ophthalmic · 385d
Cleared Oct 18, 1993
UNI II
K925756
Rudolf Riester GmbH & Co. KG
Ophthalmic · 339d
Cleared Oct 15, 1993
RI-FORMER
K932504
Rudolf Riester GmbH & Co. KG
Ophthalmic · 147d
Cleared Aug 03, 1993
OPHTHALMOSCOPE
K925757
Rudolf Riester GmbH & Co. KG
Ophthalmic · 263d
Cleared Mar 29, 1993
MIS
K923543
Ceram Optec, Inc.
Ophthalmic · 256d
Cleared Oct 04, 1985
INDIRECT OPHTHALMOSCOPE
K853891
Carl Zeiss, Inc.
Ophthalmic · 15d
Cleared Aug 16, 1983
MEDIC LUX DIAGNOSTIC SETS
K832437
Keeler Instruments, Inc.
Ophthalmic · 22d
Cleared Mar 09, 1983
DORC LIGHTWEIGHT BINOCULAR OPHTHALMOSCOP
K830215
Jedmed Instrument Co.
Ophthalmic · 44d
Cleared Oct 15, 1976
SOLA COMMIDO LOUPE
K760770
Codman & Shurtleff, Inc.
Ophthalmic · 11d
Cleared Oct 15, 1976
SOLA SCHULTZE-CROCK OPTHALMOSCOPE
K760771
Codman & Shurtleff, Inc.
Ophthalmic · 11d

About Product Code HLJ - Regulatory Context