Panels › General, Plastic Surgery › Product code HRM · Class 1
Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
Regulation 878.4700
0510(k)s in 12 months (14 all time)
0recalls in 12 months (7 all time)
0recalls that name a 510(k)
Top companies in HRM
| Company | 510(k)s | Recalls |
|---|---|---|
| Keeler Instruments, Inc. | 4 | 0 |
| Leica Microsystems, Inc. | 0 | 3 |
| Alcon Research, Ltd. | 0 | 2 |
| Alcon Laboratories | 1 | 0 |
| Alcon Research Laboratories Ltd. | 0 | 1 |
| Carl Zeiss, Inc. | 1 | 0 |
| Haag-Streit USA Inc | 0 | 1 |
| Hill-Med, Inc. | 1 | 0 |
| Lumenis, Inc. | 1 | 0 |
| Marco Ophthalmic, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 7, 1993 | K932720 | HM-0970 Hill-Med, Inc. | HRM |
| Jul 22, 1993 | K930439 | MARCO SURGISCOPE OPERATION MICROSCOPES Marco Ophthalmic, Inc. | HRM |
| Oct 9, 1992 | K920641 | ALCON OPERATING MICROSCOPES Alcon Laboratories | HRM |
| Feb 3, 1992 | K914956 | KEELER KONAN SPECULAR MICROSCOPE SP5500 Keeler Instruments, Inc. | HRM |
| Jun 8, 1989 | K891584 | S 22 INSTRUMENT STAND Carl Zeiss, Inc. | HRM |
| Apr 11, 1989 | K891001 | MICROSCOPE KNOB COVER, STERILE, DISPOSABLE Prescott'S, Inc. | HRM |
| Dec 16, 1985 | K854440 | MODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50 Keeler Instruments, Inc. | HRM |
| Oct 15, 1985 | K853855 | XTAL X-150 OPERATING MICROSCOPE Xtal Corp. | HRM |
| Jul 30, 1985 | K852586 | CROMIC SURGICAL MICROSCOPE MODEL MC-1 Seltrex, Corp. | HRM |
| Jun 3, 1985 | K852150 | CLINICAL WIDEFIELD SPECULAR MICRISCOPE 500 Keeler Instruments, Inc. | HRM |
| May 31, 1985 | K850270 | CORNEAL LIGHT SHIELD Mentor O & O, Inc. | HRM |
| Nov 21, 1984 | K844323 | KONAN CLINIC MICROSCOPE CLM-100-150 Keeler Instruments, Inc. | HRM |
| Sep 14, 1982 | K822563 | OPHTHALMIC MICROSCOPE Treace Medical, Inc. | HRM |
| Nov 16, 1979 | K792083 | HAAG-STREIT SLIT LAMP 900 Lumenis, Inc. | HRM |
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