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STERiLANCE

Sterilance Medical (Suzhou) Inc. · Model LDE4 · UDI-DI 16945630142007

QRL
10
510(k) clearances
238
Adverse events
1
Recalls
87
Facilities

Recalls

DateFirmReason
2025-07-25Home Health US, IncorporatedDue to incorrect/lack of Unique Device Identifier (UDI) codes.

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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.