Data / Medical devices / Syringe, Cartridge
Syringe, Cartridge (EJI): 50 FDA-registered makers in 17 countries
50 establishments in 17 countries are registered with the FDA to make Syringe, Cartridge (product code EJI, Class 2, 21 CFR 872.6770). 10 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 45 510(k) clearances under this code, the latest on November 16, 2017, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- EJI
- Device class
- 2
- Regulation
- 872.6770
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| Pakistan | 19 |
| United States | 9 |
| South Korea | 4 |
| France | 3 |
| United Kingdom | 2 |
| China | 2 |
| Denmark | 1 |
| Canada | 1 |
| Poland | 1 |
| Brazil | 1 |
| Australia | 1 |
| India | 1 |
| Italy | 1 |
| United Arab Emirates | 1 |
| Latvia | 1 |
| Germany | 1 |
| Switzerland | 1 |
Makers of Syringe, Cartridge
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 |
|---|---|---|---|---|---|---|---|---|
| Milestone Scientific, Inc. | Roseland, NJ, United States | Complaint file establishment, Manufacturer, Specification developer | 3 | August 8, 2006 | 0 | 1 | 0 | api.fda.gov |
| Integra LifeSciences Production Corporation | Mansfield, MA, United States | Specification developer | 2 | October 30, 2014 | 0 | 0 | 0 | api.fda.gov |
| Accompany Surgical | SIALKOT Punjab, Pakistan | Manufacturer | 1 | November 6, 2012 | 0 | 0 | 0 | api.fda.gov |
| Goldstar Medical Instruments | SIALKOT Punjab, Pakistan | Manufacturer | 1 | November 6, 2012 | 0 | 0 | 0 | api.fda.gov |
| Hu-Friedy MFG. Co. LLC | Northbrook, IL, United States | Manufacturer, Repackager or relabeler, Specification developer | 1 | November 6, 2012 | 0 | 0 | 0 | api.fda.gov |
| J & J Instruments, LLC | Northbrook, IL, United States | Specification developer | 1 | November 6, 2012 | 0 | 0 | 0 | api.fda.gov |
| Osung MND Co., Ltd. | Gimpo-si Gyeonggi, South Korea | Manufacturer | 1 | July 16, 1984 | 0 | 0 | 0 | api.fda.gov |
| Ronvig Dental MFG. A/S | DAUGAARD Midtjylland, Denmark | Manufacturer | 1 | October 13, 2000 | 0 | 0 | 0 | api.fda.gov |
| Septodont | CEDEX Val-de-Marne, France | Contract manufacturer, Manufacturer | 1 | July 11, 1995 | 0 | 0 | 0 | api.fda.gov |
| Sofic SAS | Mazamet, Cedex Tarn, France | Manufacturer | 1 | July 11, 1995 | 0 | 0 | 0 | api.fda.gov |
| Acme Commercial Ways Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arnold Tuber Industries | Orchard Park, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B&H Surgical Instrument | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B. Ali Impex | SIALKOT, Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beyes Dental Inc | Toronto Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bailey Instruments Ltd | Manchester, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Confident Instruments | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Densol International (private) Limited | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Denta Craft Instruments | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dental Hi Tec | Mazieres en Mauges Maine-et-Loire, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dental Studio | Anyang-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentis Medical Division | Daegu, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DTR Medical Ltd | Swansea, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Emerald Instruments | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foshan Coxo Medical Instrument Co., Ltd. | Foshan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fabryka Narzedzi Medycznych CHIRMED Marcin Dyner Spolka Komandytowa | RUDNIKI K/CZESTOCHOWY Slaskie, Poland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guilin Woodpecker Medical Instrument Co., Ltd | GUILIN CITY Guangxi, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hexa Dental | Commerce, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Indusbello Industria De Instrumentos Odo | Londrina Parana, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inka Surgical Instruments | Jandakot Western Australia, Australia | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jaffrose International | Sialkot Punjab, Pakistan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lacigrus International | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Laparomed Private Limited | Mumbai Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lohar Medical Company | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medcave Private Limited | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDESY srl | MANIAGO Pordenone, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medihub Co., Ltd. | Gunpo-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nextcon International | Sialkot Punjab, Pakistan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Perfect Ophthalmic Instruments FZE | Dubai Dubayy, United Arab Emirates | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RUMEX Baltics SIA | Riga, Latvia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Signor Seven International | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Silver Plus Corp. | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STS Corporation | Duluth, GA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgicrafts | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tontarra Medizintechnik GMBH | WURMLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tricor Systems | Elgin, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wise Instruments | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Young Innovations Inc. | Algonquin, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| medmix Switzerland AG | Haag Sankt Gallen, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 16, 2017. 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.