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Transformer, Endoscope

FDA product code GCW · Class 2 · Gastroenterology, Urology

127
Registered devices
3
Adverse events
6
Recalls
1
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2017-04-13Pentax of America IncPentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s comp
2017-04-13Pentax of America IncPentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s comp
2017-04-13Pentax of America IncPentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s comp
2017-04-13Pentax of America IncPentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s comp
2015-02-11EXP Pharmaceutical Services CorpEXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that
2015-02-11EXP Pharmaceutical Services CorpEXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.