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PANOVIEW

Richard Wolf GmbH · Model 8964401 · UDI-DI 04055207023266

FGA
10
510(k) clearances
98
Adverse events (7 deaths)
8
Recalls
33
Facilities

Description

NEPHROSCOPE 12° 20.8FR WL 224MM rigid, with parallel ocular lens, working channel for instruments up to 10.5 Fr, TL 387 mm, rod lens system

Recalls

DateFirmReason
2024-07-23Karl Storz EndoscopyVarious medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
2024-07-23Karl Storz EndoscopyVarious medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
2024-07-23Karl Storz EndoscopyVarious medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
2024-07-23Karl Storz EndoscopyVarious medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
2024-07-23Karl Storz EndoscopyVarious medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
2024-07-23Karl Storz EndoscopyVarious medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
2024-07-23Karl Storz EndoscopyVarious medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
2024-07-23Karl Storz EndoscopyVarious medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

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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.