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Millennium

Avalign Technologies, Inc. · Model 72-5280010 · UDI-DI 00190776369484

FXM Prescription
1
510(k) clearances
15
Adverse events
5
Recalls
16
Facilities

Description

Digital Camera 1000S System, USB HD Endoscopic Camera System

Recalls

DateFirmReason
2004-02-19Smith And Nephew, Inc. Endoscopy DivisionEndocouplers assembled with screws that cannot be effectively sterilized
2004-02-19Smith And Nephew, Inc. Endoscopy DivisionEndocouplers assembled with screws that cannot be effectively sterilized
2004-02-19Smith And Nephew, Inc. Endoscopy DivisionEndocouplers assembled with screws that cannot be effectively sterilized
2004-02-19Smith And Nephew, Inc. Endoscopy DivisionEndocouplers assembled with screws that cannot be effectively sterilized
2004-02-19Smith And Nephew, Inc. Endoscopy DivisionEndocouplers assembled with screws that cannot be effectively sterilized

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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.