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Pentax Medical Company

29 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Colonoscope Product Usage: Intended to provide optical visualization of and therapeutic ac recall (Z-2275-2016)Pentax Medical Company2016-07-23
Confocal GI Scope Product Usage: Intended to provide optical visualization of and therapeu recall (Z-2276-2016)Pentax Medical Company2016-07-23
Duodenoscope Product Usage: Intended to provide optical visualization of and therapeutic a recall (Z-2277-2016)Pentax Medical Company2016-07-23
Gastroscope Product Usage: Intended to provide optical visualization of and therapeutic ac recall (Z-2278-2016)Pentax Medical Company2016-07-23
Ultrasound Gastroscope Product Usage: Intended to provide optical visualization of, ultras recall (Z-2279-2016)Pentax Medical Company2016-07-23
Signmoidoscope Product Usage: Intended to provide optical visualization of, therapeutic ac recall (Z-2280-2016)Pentax Medical Company2016-07-23
Bronchoscope Intended to provide optical visualization of and therapeutic access to the Ai recall (Z-2065-2016)Pentax Medical Company2016-06-28
Choledocho-Nephroscope Intended to provide optical visualization of and therapeutic access recall (Z-2066-2016)Pentax Medical Company2016-06-28
Choledochoscope Intended to provide optical visualization of and therapeutic access to the recall (Z-2067-2016)Pentax Medical Company2016-06-28
Colonoscope Intended to provide optical visualization of and therapeutic access to the Low recall (Z-2068-2016)Pentax Medical Company2016-06-28
Confocal GI Scope Intended to provide optical visualization of an therapeutic access to th recall (Z-2069-2016)Pentax Medical Company2016-06-28
Cystoscope Intended to provide optical visualization of and therapeutic access to the Urin recall (Z-2070-2016)Pentax Medical Company2016-06-28
Gastroscope Intended to provide optical visualization of and therapeutic access to the Upp recall (Z-2071-2016)Pentax Medical Company2016-06-28
Intubation Scope Intended to provide optical visualization of, therapeutic access to, and recall (Z-2072-2016)Pentax Medical Company2016-06-28
Laryngo Stroboscope Product Usage Intended to provide optical visualization of, therapeuti recall (Z-2073-2016)Pentax Medical Company2016-06-28
Naso-Pharyngo-Laryngoscope Intended to provide optical visualization of, therapeutic acces recall (Z-2074-2016)Pentax Medical Company2016-06-28
Signmoidoscope Intended to provide optical visualization of, therapeutic access to, the Lo recall (Z-2075-2016)Pentax Medical Company2016-06-28
Ultrasound Bronchoscope Intended to provide optical visualization of, ultrasonic visualiza recall (Z-2076-2016)Pentax Medical Company2016-06-28
Ultrasound Gastroscope Intended to provide optical visualization of, ultrasonic visualizat recall (Z-2077-2016)Pentax Medical Company2016-06-28
Ureteroscope Intended to provide optical visualization of and therapeutic access to the Ur recall (Z-2078-2016)Pentax Medical Company2016-06-28
Esophagoscope Gastrointestinal Tract. This anatomy includes, but is not restricted to, the recall (Z-2079-2016)Pentax Medical Company2016-06-28
Small Bowel Scope Gastrointestinal Tract. This anatomy includes, but is not restricted to, recall (Z-2080-2016)Pentax Medical Company2016-06-28
PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve recall (Z-2290-2014)Pentax Medical Company2014-08-21
EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ul recall (Z-2116-2014)Pentax Medical Company2014-07-24
PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes recall (Z-0084-2014)Pentax Medical Company2013-10-28
EG-3870UTK, Pentax Ultrasound Video Gastroscope. The EG-3870UTK, Ultrasound Video Gastrosc recall (Z-1489-2012)Pentax Medical Company2012-05-03
EB- Series Video Bronchoscopes, EB-1570K & EB-1970K. Intended to provide optical visualiza recall (Z-0818-2012)Pentax Medical Company2012-01-20
EE- Series Video Esophagoscopes, EE-1580K. Intended to provide optical visualization of (v recall (Z-0819-2012)Pentax Medical Company2012-01-20
EE- Series Video Naso Pharyngo Laryngo Scope, VNL-1570STK. Intended to provide optical vis recall (Z-0820-2012)Pentax Medical Company2012-01-20

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Every clearance here is in the API, with alerts when new ones post.