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StrongArm Surgical Holders and Positioners

FLEXBAR MACHINE CORPORATION · Model 73002-NC · UDI-DI 00842102113963

FFO
5
510(k) clearances
86
Adverse events
3
Recalls
152
Facilities

Description

StrongArm Cvd Post Sys,Short Dstl Arm w/Quick-Connect Fit. (no Rail Clamp)

Recalls

DateFirmReason
2024-12-03Sklar InstrumentsReports of various packaging issues that may result in a breach of the sterile barrier.
2015-11-25Abeon Medical CorporationThe firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.
2015-11-25Abeon Medical CorporationThe firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.

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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.