Panels › General, Plastic Surgery › Product code EPT · Class 1
Microscope, Surgical
Regulation 878.4700
0510(k)s in 12 months (18 all time)
0recalls in 12 months (14 all time)
0recalls that name a 510(k)
Top companies in EPT
| Company | 510(k)s | Recalls |
|---|---|---|
| Leica Microsystems, Inc. | 0 | 6 |
| Carl Zeiss Meditec Inc | 0 | 4 |
| Storz Instrument Co. | 4 | 0 |
| Carl Zeiss, Inc. | 3 | 0 |
| Haag-Streit USA Inc | 0 | 3 |
| Jedmed Instrument Co. | 2 | 0 |
| Kelleher Corp. | 2 | 0 |
| Alcon Laboratories | 1 | 0 |
| The Lebanon Corp. | 1 | 0 |
| Micrins Surgical, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 9, 2022 | Leica Microsystems, Inc. Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system Open, Classified |
EPT | None listed |
| Dec 9, 2022 | Leica Microsystems, Inc. Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard).
Surgical microscope system Open, Classified |
EPT | None listed |
| May 20, 2020 | Leica Microsystems, Inc. Leica ARveo and M530 OH6 microscope systems. Terminated |
EPT | None listed |
| Jul 31, 2019 | Haag-Streit USA Inc HS Hi-R NEO 900A NIR
Reference # 657 822
Serial # from 101
Product Usage:
A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment Terminated |
EPT | None listed |
| Jul 31, 2019 | Haag-Streit USA Inc HS Hi-R NEO 900A
Reference # 657 821
Serial # from 101
Product Usage:
A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment and Terminated |
EPT | None listed |
| Jul 31, 2019 | Haag-Streit USA Inc HS Hi-R NEO 900
Reference # 657 820
Serial # from 101
Product Usage:
A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment and Terminated |
EPT | None listed |
| Sep 14, 2018 | Leica Microsystems, Inc. Leica M525 F20 Surgical Microscope System Terminated |
EPT | None listed |
| Jun 4, 2018 | Leica Microsystems, Inc. Leica Microsystems products labeled as the following: Leica M320 Microscope Systems with Article Numbers 10448419, 10448420, 10448485, 10448486
Product Usage:
Intended use of this device is an optica Terminated |
EPT | None listed |
| Jan 1, 2017 | Seiler Instr. & Mfg. Co. Inc. Alpha Air 6 ENT Microscope
Microscope examination of the human ear, nose, and throat. Open, Classified |
EPT | None listed |
| May 31, 2013 | Carl Zeiss Meditec, Inc. Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI Pentero C, Product Numbers: 302583-9001-000 (PENTERO C), and 305961-0000-00 (Ceiling Mount for PENTERO C),
Product Usage: Terminated |
EPT | None listed |
| Oct 24, 2011 | Carl Zeiss Meditec, Inc. OPMI VARIO 700 Surgical Microscope.
Manufactured by: Carl Zeiss Meditec AG,
Oberkochen, Germany.
Provide a magnified view of the surgical field. Terminated |
EPT | None listed |
| Sep 23, 2011 | Carl Zeiss Meditec, Inc. OPMI Pentero, OPMI Pentero C, OPMI Pentero 900,
OPMI Vario/S8, OPMI Vario/S88, OPMI Neuro Multivision/NC4,
OPMI Vario/NC33, OPMI Neuro/NC4, OPMI Neuro/NC4 Ceiling Mount.
A surgical microscope and ac Terminated |
EPT | None listed |
| Jan 14, 2011 | Carl Zeiss Meditec Inc VISU 200 on S8 Floor Stand, Manufactured by Carl Zeiss Surgical GmbH, Germany
Medical device: Surgical microscope used during ophthalmic surgeries, which allows real time visualization of the surgical Terminated |
EPT | None listed |
| Jun 24, 2006 | Leica Microsystems, Inc. Leica M520 Surgical Microscope; a surgical microscope with a 6:1 motorized zoom magnification, 207-470 mm motorized Multi-Foc variable objective lens with diameter and light intensity of illuminated f Terminated |
EPT | None listed |
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