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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-2078-2016 - Ureteroscope
Intended to provide optical visualization of and therapeutic access to the Urinary Track. This anatomy includes but is not restricted to the organs, tissues and subsystems: Urethra, Blad...
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2
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06/28/2016
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Pentax Medical Company
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Z-2077-2016 - Ultrasound Gastroscope
Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to organs, ti...
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2
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06/28/2016
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Pentax Medical Company
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Z-2076-2016 - Ultrasound Bronchoscope
Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Pulmonary Tract including but not restricted to organs, tissues and su...
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2
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06/28/2016
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Pentax Medical Company
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Z-2080-2016 - Small Bowel Scope
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 mo...
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2
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06/28/2016
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Pentax Medical Company
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Z-2075-2016 - Signmoidoscope
Intended to provide optical visualization of, therapeutic access to, the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsyste...
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2
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06/28/2016
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Pentax Medical Company
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Z-2074-2016 - Naso-Pharyngo-Laryngoscope
Intended to provide optical visualization of, therapeutic access to, the Upper Airway. 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-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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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-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-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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