Data / Medical devices / Injector, Fluid, Non-Electrically Powered
Injector, Fluid, Non-Electrically Powered (KZE): 7 FDA-registered makers in 4 countries
7 establishments in 4 countries are registered with the FDA to make Injector, Fluid, Non-Electrically Powered (product code KZE, Class 2, 21 CFR 880.5430). 5 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 53 510(k) clearances under this code, the latest on July 19, 2012, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KZE
- Device class
- 2
- Regulation
- 880.5430
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Germany | 1 |
| Israel | 1 |
| Singapore | 1 |
Makers of Injector, Fluid, Non-Electrically Powered
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 |
|---|---|---|---|---|---|---|---|---|
| Injex Pharma GMBH | Berlin, Germany | Manufacturer | 1 | September 25, 2002 | 0 | 0 | 0 | api.fda.gov |
| Mada Medical Products, Inc. | Carlstadt, NJ, United States | Manufacturer | 1 | December 10, 1985 | 0 | 0 | 0 | api.fda.gov |
| National Medical Products, Inc. | Irvine, CA, United States | Manufacturer | 1 | November 24, 1997 | 0 | 0 | 0 | api.fda.gov |
| Pharmajet, Inc. | Golden, CO, United States | Manufacturer for export, Specification developer | 1 | July 27, 2011 | 0 | 0 | 0 | api.fda.gov |
| Viora Ltd. | Migdal HaEmek Northern, Israel | Manufacturer | 1 | January 23, 2009 | 0 | 0 | 0 | api.fda.gov |
| Trident Manufacturing, Inc. | Pingree Grove, IL, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Univac Precision Engineering Pte Ltd | Singapore North West, Singapore | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 19, 2012. 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.