Promex, Inc.
United StatesFDA applicant, unverified
- Devices
- 18
What Promex, Inc. makes
Promex, Inc. manufactures automated and manual biopsy devices, including vitrectomy tools, spinal and bone biopsy needles, breast lesion localization needles, and automated core biopsy systems. Their portfolio also includes surgical cutters, co-axial introducer needles, K-wire and Steinmann pins, and tissue markers for biopsy sites. The company produces instruments for gastroenterology, urology, and orthopedic procedures, as well as aspiration biopsy needles like Chiba, Fraseneen, and Westcott styles.
Promex’s devices are regulated under FDA Class I and Class II classifications, with most products requiring 510(k) clearance. The company’s instruments are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Search and filter all 18 devicesFrequently asked questions
How many devices does Promex, Inc. have in the registry?
The registry currently lists 18 devices for Promex, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Promex, Inc.'s devices?
Among its 18 most recently registered devices, Promex, Inc. has devices listed in FDA 510(k) (18 devices).
What risk classes do Promex, Inc.'s devices fall under?
Among its 18 most recently registered devices, the classes recorded for Promex, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Promex, Inc. in the registry?
The most recently registered devices listed for Promex, Inc. include AUTOMATED VITRECTOMY DEVICE, CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE, BREAST LESION LOCALIZATION NEEDLE and AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT.