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ZD

Zhende Medical Co., Ltd. · Model / · UDI-DI 06959385758317

PQE
0
510(k) clearances
1
Adverse events
1
Recalls
22
Facilities

Description

Two-piece Ostomy Bag

Recalls

DateFirmReason
2017-10-26ConvaTec, IncA portion of Lot 7H02242 outer boxes (market units) of the SUR-FIT Natura Moldable Durahesive Skin Barrier (10 pack, 45 mm, REF 411802) were incorrectly labeled as Natura Moldable

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.