Panels › Ophthalmic › Product code HLZ · Class 2
Electrode, Corneal
Regulation 886.1220
1510(k)s in 12 months (11 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in HLZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Retmap, Inc. | 2 | 0 |
| Cadwell Laboratories, Inc. | 1 | 0 |
| Doran Instruments, Inc. | 1 | 0 |
| Life-Tech Instruments, Inc. | 1 | 0 |
| Lkc Technologies, Inc. | 1 | 0 |
| Nicolet Biomedical Instruments | 1 | 0 |
| Sauquoit Industries, Inc. | 1 | 0 |
| Thomasville Medical Assoc. | 1 | 0 |
| Tomey Corporation USA | 1 | 0 |
| Universo S.A. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 1, 2026 | K253586 | RM Electrode (RMH 25-01) Retmap, Inc. | HLZ |
| Dec 7, 2023 | K232273 | RM Electrode (RMH 23-01) Retmap, Inc. | HLZ |
| May 9, 1997 | K961805 | TOMEY DTL ELECTRODE Tomey Corporation USA | HLZ |
| Feb 25, 1994 | K926540 | SOPHER AND BIERER OVUM FORCEPS Thomasville Medical Assoc. | HLZ |
| Jan 31, 1992 | K913239 | GOLDLENS(TM) Doran Instruments, Inc. | HLZ |
| Feb 14, 1985 | K844409 | DTL ELECTRODE Sauquoit Industries, Inc. | HLZ |
| Mar 31, 1983 | K830557 | ERG-JET ELECTRODE Universo S.A. | HLZ |
| Apr 9, 1982 | K820254 | GOLD FOIL ERG ELECTRODES Cadwell Laboratories, Inc. | HLZ |
| Jan 22, 1982 | K813399 | ERG-JET ELECTRODE Nicolet Biomedical Instruments | HLZ |
| Nov 15, 1978 | K781476 | MULAR GOLD LEAF ELECTRODE MODEL 7501 Life-Tech Instruments, Inc. | HLZ |
| Aug 4, 1976 | K760199 | ELECTRORETINOGRAPH Lkc Technologies, Inc. | HLZ |
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