Data / Medical devices / Microscope, Phase Contrast
Microscope, Phase Contrast (IBM): 12 FDA-registered makers in 5 countries
12 establishments in 5 countries are registered with the FDA to make Microscope, Phase Contrast (product code IBM, Class 1, 21 CFR 864.3600). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on June 13, 1989, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- IBM
- Device class
- 1
- Regulation
- 864.3600
- Medical specialty
- Pathology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Japan | 4 |
| China | 2 |
| Germany | 1 |
| India | 1 |
Makers of Microscope, Phase Contrast
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Celltivity Scientific, Inc | Waltham, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cision Vision | San Mateo, CA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Caliber Imaging & Diagnostics, Inc. | Rochester, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carl Zeiss Microscopy, GmbH | Jena Thuringia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carl Zeiss Suzhou Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Evident Corporation | Kamiina-gun Nagano, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Evident Corporation | Hachioji-shi Tokyo, Japan | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Evident Nagano Corporation | Kamiina-gun Nagano, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Invenio Imaging, Inc. | San Jose, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Labotech Microscopes India Private Limited | AMBALA CANTT Haryana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nanjing Nikon Jiangnan Optical Instrument Co., Ltd. | Nanjing Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nikon Corporation | SHINAGAWA-KU Tokyo, Japan | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 13, 1989. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.