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Mediox

Mediox Medical Service Ltd · Model FA08409 · UDI-DI 00850054612199

OCJ Prescription
1
510(k) clearances
20
Adverse events
2
Recalls
48
Facilities

Description

Mediox medical, Kyphoplasty Tool Kit,include guide wire,drill,bone cement filler ,puncture needle and cannula,dilator and working cannula. Model FA08409 Product content is Puncture needle 3.7

Recalls

DateFirmReason
2011-03-22DePuy Spine, Inc.Mislabeled: Package labeled (11g x 6 inch) contains a 13g x 4-inch side hole needle
2011-03-22DePuy Spine, Inc.Mislabeled: Package labeled (11g x 6 inch) contains a 13g x 4-inch side hole needle

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Data 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.