Pentax Precision Instrument Corp. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Pentax Precision Instrument Corp. - FDA 510(k) Cleared Devices
Recent clearances: EG-3630UR, FG-36UX FIBER ULTRASOUND GASTROSCOPE, EG-3830UT
67
Total
67
Cleared
0
Denied
Pentax Precision Instrument Corp. has 67 FDA 510(k) cleared medical devices. Based in Mchenry, US.
Historical record: 67 cleared submissions from 1979 to 2004. Primary specialty: Gastroenterology & Urology.
Browse the FDA 510(k) cleared devices submitted by Pentax Precision Instrument Corp. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Tuv Rheinland of North America, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Pentax Precision Instrument Corp.
67 devices
Cleared
Jun 09, 2004
EG-3630UR
Radiology
14d
Cleared
Jun 09, 2004
FG-36UX FIBER ULTRASOUND GASTROSCOPE
Radiology
14d
Cleared
Jun 09, 2004
EG-3830UT
Radiology
14d
Cleared
Aug 08, 2003
EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE
Radiology
59d
Cleared
Feb 11, 2003
EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE
Radiology
125d
Cleared
Oct 16, 2002
EB-1830T3, VIDEO BRONCHOSCOPE
Ear, Nose, Throat
8d
Cleared
Sep 12, 2002
FG-36UX FIBER ULTRASOUND GASTROSCOPE
Radiology
143d
Cleared
Sep 06, 2002
EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE
Radiology
137d
Cleared
Feb 04, 2002
EG-3630UR, ULTRASUND VIDEO GASTROSCOPE
Radiology
91d
Cleared
Apr 17, 2001
FG-36UX, FIBER ULTRASOUND GASTROSCOPE
Radiology
35d
Cleared
Sep 04, 1997
AP-4000, AIR PULSE SENSORY STIMULATOR
Neurology
279d
Cleared
Feb 10, 1997
FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE
Radiology
266d
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