Data / Medical devices / Holder, Syringe, Lead
Holder, Syringe, Lead (IWR): 10 FDA-registered makers in 6 countries
10 establishments in 6 countries are registered with the FDA to make Holder, Syringe, Lead (product code IWR, Class 1, 21 CFR 892.6500). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on February 19, 1994, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- IWR
- Device class
- 1
- Regulation
- 892.6500
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| China | 1 |
| Denmark | 1 |
| Pakistan | 1 |
| Canada | 1 |
| France | 1 |
Makers of Holder, Syringe, Lead
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 |
|---|---|---|---|---|---|---|---|---|
| Ebayga Radiation Shielding Technology (shanghai) Co., Ltd | Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ergodenta Aps | Taastrup Hovedstaden, Denmark | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lemer Pax America | Montreal Quebec, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lemer-Pax | Carquefou Loire-Atlantique, France | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mirion Technologies (capintec), Inc | Florham Park, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Radiation Products Design, Inc. | Albertville, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Radium Incorporated | Waynesboro, VA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Radnostix | Idaho Falls, ID, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sirtex Medical Inc. | Woburn, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 19, 1994. 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.