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Stone Extraction Balloon
Jiangsu Vedkang Medical Science and Technology Co.,Ltd. · Model VDK-BAL-23-11/13/15-B · UDI-DI 06970057571027
GCA
Prescription
1
510(k) clearances
441
Adverse events (1 deaths)
2
Recalls
35
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-02-11 | EXP Pharmaceutical Services Corp | EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were re |
| 2002-08-28 | Wilson-Cook Medical Inc | The product was labeled with a 5 year expiration date instead of a 1 year expiration date. |
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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.