Hamamatsu Corp.
Bridgewater, NJ, US
HAMAMATSU CORP. appears in FDA device records in Bridgewater, NJ. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2247528 | 1000121818 | HAMAMATSU CORP. | 360 FOOTHILL RD., BRIDGEWATER, NJ 08807 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2280-2023 | NanoZoomer S360MD Slide scanner system-automated system for creating, viewing, and managing digital slides. The NanoZoomer System creates diagnostic-quality digital images of glass slides containing formalin-fixed paraffin-embedded (FFPE) tissue. Catalog Number: C13220-01MD | If the wrong barcode information is recorded in the NDPi file, a pathologist may refer to the whole slide image (WSI) of a different patient. | Class II | Open, Classified | |
| Z-3076-2011 | Hamamatsu model L10951-35 Micro Focus x-ray generator. The x-ray generator is incorporated into a cabinet x-ray system that is used for a variety of studies. | It was discovered about a potential issue of X-ray leakage with our Model # LI1 0951-35 Micro Focus X-Ray generator. | Terminated | ||
| Z-1224-2012 | Hamamatsu Corporation, Bridgewater NJ 08807 Microfocus X-ray Source L8601 series, L9121 series (90kV type MICROFOCUS X-RAY SOURCE), L7901 series, and L8031 series (100kV type MICROFOCUS x-ray source | It was discovered that the Micro Focus X-ray Source could be experiencing software related problems that would allow the unit to exceed the maximum power setting that was set by the operator. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain