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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-2065-2016 - Bronchoscope
Intended to provide optical visualization of and therapeutic access to the Airway and Bronchial Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems:...
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2
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06/28/2016
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Pentax Medical Company
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Z-2066-2016 - Choledocho-Nephroscope
Intended to provide optical visualization of and therapeutic access to the Abdominal Cavity. This anatomy includes, but is not restricted to, the organs, tissues and subsystems...
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2
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06/28/2016
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Pentax Medical Company
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Z-2067-2016 - Choledochoscope
Intended to provide optical visualization of and therapeutic access to the Biliary Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Common Bi...
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2
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06/28/2016
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Pentax Medical Company
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Z-2068-2016 - Colonoscope
Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystem...
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2
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06/28/2016
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Pentax Medical Company
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Z-2069-2016 - Confocal GI Scope
Intended to provide optical visualization of an therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems...
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2
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06/28/2016
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Pentax Medical Company
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Z-2070-2016 - Cystoscope
Intended to provide optical visualization of and therapeutic access to the Urinary Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Urethra to th...
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2
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06/28/2016
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Pentax Medical Company
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Z-2079-2016 - Esophagoscope
Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth ...
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2
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06/28/2016
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Pentax Medical Company
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Z-2071-2016 - Gastroscope
Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystem...
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2
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06/28/2016
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Pentax Medical Company
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Z-2072-2016 - Intubation Scope
Intended to provide optical visualization of, therapeutic access to, and use to facilitate routine or difficult tracheal intubations of the Upper Airway. This anatomy includes, but i...
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2
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06/28/2016
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Pentax Medical Company
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Z-2073-2016 - Laryngo Stroboscope
Product Usage Intended to provide optical visualization of, therapeutic access to, the Upper Airway and Vocal Folds. This anatomy includes, but is not restricted to, the organs, t...
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2
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06/28/2016
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Pentax Medical Company
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