Panels › Ophthalmic › Product code HLJ · Class 2
Ophthalmoscope, Battery-Powered
Regulation 886.1570
0510(k)s in 12 months (47 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in HLJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Rudolf Riester GmbH & Co. KG | 6 | 0 |
| Heine Optotechnik GmbH & Co. KG | 5 | 0 |
| Neitz Instruments Company, Ltd. | 5 | 0 |
| Design Med. Corp. | 3 | 0 |
| Keeler Instruments, Inc. | 3 | 0 |
| R & D Batteries, Inc. | 3 | 0 |
| Codman & Shurtleff, Inc. | 2 | 0 |
| Randwal Instrument Co., Inc. | 2 | 0 |
| Access / God Loves You | 1 | 0 |
| Alexander Mfg. Co. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 18, 2015 | K142486 | HEINE BETA 200, HEINE BETA 200 S, HEINE K 180 Heine Optotechnik GmbH & Co. KG, DE | HLJ |
| Jan 29, 2015 | K142837 | HEINE SIGMA 250 & HEINE SIGMA 250 M2 Heine Optotechnik GmbH & Co. KG, DE | HLJ |
| Mar 7, 2014 | K131959 | HEINE MINI 3000(R) OPHTHALMOSCOPE Heine Optotechnik GmbH & Co. KG, DE | HLJ |
| Dec 4, 2013 | K131961 | HEINE BETA 200(R) OPHTHALMOSCOPE Heine Optotechnik GmbH & Co. KG, DE | HLJ |
| Oct 30, 2013 | K131719 | OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS Medical Devices (Pvt) , Ltd., PK | HLJ |
| Mar 22, 2013 | K123587 | HEINE MINI 3000 LED OPHTHALMOSCOPE Heine Optotechnik GmbH & Co. KG, DE | HLJ |
| Nov 19, 2010 | K093495 | OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS American Diagnostic Corp. | HLJ |
| Nov 5, 2007 | K070270 | PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36 Kirchner & Wilhelm GmbH + Co.Kg | HLJ |
| Nov 7, 2006 | K052599 | 66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A Suzhou 66 Vision Tech Co., Ltd., CN | HLJ |
| May 16, 2006 | K061278 | OPTYSE OPHTHALMOSCOPE Ophthalmos , Ltd., GB | HLJ |
| Jan 9, 2006 | K053425 | PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS Precision Optics Corp. | HLJ |
| Nov 26, 2003 | K032087 | KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004 Keeler Instruments, Inc. | HLJ |
| Sep 12, 2000 | K002044 | MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT Magna Fortis Corporation | HLJ |
| Jul 3, 1997 | K962767 | MS401097-17,MS722-K,MS720,MS721,MS722 Alexander Mfg. Co. | HLJ |
| Apr 2, 1997 | K970029 | KEELER SPECTRA INDIRECT OPHTHALMOSCOPE Keeler Instruments, Inc. | HLJ |
| Jul 24, 1995 | K950914 | 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 Rudolf Riester GmbH & Co. KG, DE | HLJ |
| Mar 28, 1995 | K950797 | HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134 Neitz Instruments Company, Ltd., JP | HLJ |
| Mar 22, 1995 | K950796 | HALOGEN DIAGNOSTIC SET BX A - 12345 Neitz Instruments Company, Ltd., JP | HLJ |
| Jan 17, 1995 | K945640 | RI-SCOPE S OTOSCOPE Rudolf Riester GmbH & Co. KG, DE | HLJ |
| Nov 22, 1994 | K944402 | FOCOMETER Lacrimedics, Inc. | HLJ |
| Aug 5, 1994 | K942721 | NEITZ HALOGEN OPHTHALMOSCOPE BXA-13 Neitz Instruments Company, Ltd. | HLJ |
| Aug 5, 1994 | K942719 | NEITZ HALOGEN POCKET OPHTHALMOSCOPE A-JR Neitz Instruments Company, Ltd. | HLJ |
| Aug 5, 1994 | K942717 | NEITZ HALOGEN OPHTHALMOSCOPE BXA-13A Neitz Instruments Company, Ltd. | HLJ |
| Jun 3, 1994 | K942034 | R&D BATTERIES, PART NOS. 5135, 5097, 5444, AND 5502 R & D Batteries, Inc. | HLJ |
| Feb 22, 1994 | K936104 | R & D BATTERIES R & D Batteries, Inc. | HLJ |
| Feb 22, 1994 | K936018 | REPLACEMENT BATTERIES PART NO. 5098,5135, 5097 R & D Batteries, Inc. | HLJ |
| Dec 3, 1993 | K925755 | DE LUXE Rudolf Riester GmbH & Co. KG, DE | HLJ |
| Oct 18, 1993 | K925756 | UNI II Rudolf Riester GmbH & Co. KG, DE | HLJ |
| Oct 15, 1993 | K932504 | RI-FORMER Rudolf Riester GmbH & Co. KG, DE | HLJ |
| Aug 3, 1993 | K925757 | OPHTHALMOSCOPE Rudolf Riester GmbH & Co. KG, DE | HLJ |
| Mar 29, 1993 | K923543 | MIS Ceram Optec, Inc. | HLJ |
| Sep 30, 1992 | K922910 | MEDICAL BATTERY PACKS Access / God Loves You | HLJ |
| Jul 9, 1992 | K920272 | ORIEL Truphatek, Ltd., IL | HLJ |
| Nov 27, 1989 | K896072 | D.L. SCOPE OPHTHALMOSCOPE North American Medical Products, Inc. | HLJ |
| Nov 24, 1987 | K873987 | IRAS GLARE TESTER Randwal Instrument Co., Inc. | HLJ |
| Jun 3, 1987 | K871735 | VOROSCOPE(TM) Australian Biomedical Corporation , Ltd., AU | HLJ |
| Oct 4, 1985 | K853891 | INDIRECT OPHTHALMOSCOPE Carl Zeiss, Inc. | HLJ |
| Sep 6, 1985 | K852953 | #SM-3001 OPHTHA OTOSC SET SUBSETS SOLD Design Med. Corp. | HLJ |
| Jun 18, 1985 | K852334 | MODEL BX OPHTHALMOSCOPE(BX-RP INCLUDES BATTE HAN) Design Med. Corp. | HLJ |
| Nov 27, 1984 | K843897 | POCKET OPHTHALMOSCOPE GH Design Med. Corp. | HLJ |
| Aug 15, 1984 | K842567 | PORTABLE ACUIOMETER Randwal Instrument Co., Inc. | HLJ |
| May 9, 1984 | K841292 | SPECTACLE INDIRECT OPHTHALMOSCOPE Keller Instruments, Inc. | HLJ |
| Aug 16, 1983 | K832437 | MEDIC LUX DIAGNOSTIC SETS Keeler Instruments, Inc. | HLJ |
| Mar 9, 1983 | K830215 | DORC LIGHTWEIGHT BINOCULAR OPHTHALMOSCOP Jedmed Instrument Co. | HLJ |
| Apr 10, 1978 | K780215 | EYESCOPE Visual Methods, Inc. | HLJ |
| Oct 15, 1976 | K760771 | SOLA SCHULTZE-CROCK OPTHALMOSCOPE Codman & Shurtleff, Inc. | HLJ |
| Oct 15, 1976 | K760770 | SOLA COMMIDO LOUPE Codman & Shurtleff, Inc. | HLJ |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.