Data / Medical devices / High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid
High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid (PSW): 4 FDA-registered makers in 1 country
4 establishments in 1 country are registered with the FDA to make High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid (product code PSW, Class 2, 21 CFR 892.1570). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on November 21, 2023, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PSW
- Device class
- 2
- Regulation
- 892.1570
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
Makers of High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid
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 |
|---|---|---|---|---|---|---|---|---|
| CS Medical LLC | Creedmoor, NC, United States | Manufacturer, Specification developer | 6 | November 21, 2023 | 0 | 0 | 0 | api.fda.gov |
| CIVCO Medical Instruments Co., Inc. | Coralville, IA, United States | Manufacturer | 1 | November 16, 2015 | 0 | 0 | 0 | api.fda.gov |
| Medical Chemical Corporation | Torrance, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tricor Systems | Elgin, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 21, 2023. 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.