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Wondfo
WONDFO USA CO., LTD. · Model DW52-S-SQ-25BX · UDI-DI 00816862026078
2
510(k) clearances
0
Adverse events
2
Recalls
70
Facilities
Description
25 Semi-Quantitative FSH Strips; Follicle Stimulating Hormone (FSH) 5/10/25/50 mIU/mL
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-22 | Changchun Wancheng Bio-Electron Co., Ltd. | Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause fa |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.