Data / Medical devices / Beads, Hydrophilic, For Wound Exudate Absorption
Beads, Hydrophilic, For Wound Exudate Absorption (KOZ): 7 FDA-registered makers in 3 countries
7 establishments in 3 countries are registered with the FDA to make Beads, Hydrophilic, For Wound Exudate Absorption (product code KOZ, Class 1, 21 CFR 878.4018). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 22 510(k) clearances under this code, the latest on April 12, 1991, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KOZ
- Device class
- 1
- Regulation
- 878.4018
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| China | 5 |
| Sweden | 1 |
| Taiwan | 1 |
Makers of Beads, Hydrophilic, For Wound Exudate Absorption
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 |
|---|---|---|---|---|---|---|---|---|
| Perstorp Specialty Chemicals AB, Perstorp Pharma | PERSTORP Skane lan [SE-12], Sweden | Manufacturer | 1 | January 31, 1991 | 0 | 0 | 0 | api.fda.gov |
| Dongyang City Yonoel Outdoor Products Co.,ltd | Dongyang Zhejiang, China | Exporter to the US, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| H&K International Trade Limited (china) | jinhua Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Henan Huibo Medical Co., Ltd | Nanyang City Henan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oriental Resources Development Limited | Hukou Township Hsinchu(County), Taiwan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yiwu Eo Sterilization Technology Co., Ltd. | Yiwu Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yiwu Ori-Power Medtech Co., Ltd. | YIWU Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 12, 1991. 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.