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Sklar®

SKLAR CORPORATION · Model 45-5899 · UDI-DI 10649111180651

EMI
4
510(k) clearances
0
Adverse events
4
Recalls
147
Facilities

Description

CARTILAGE FILE COARSE 9.5"

Recalls

DateFirmReason
2021-04-26Meta C.G.M. SpaSterility issues; single use devices labeled as sterile may not have been adequately sterilized
2021-04-26Meta C.G.M. SpaSterility issues; single use devices labeled as sterile may not have been adequately sterilized
2021-04-26Meta C.G.M. SpaSterility issues; single use devices labeled as sterile may not have been adequately sterilized
2021-04-26Meta C.G.M. SpaSterility issues; single use devices labeled as sterile may not have been adequately 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.