Pentax Medical Company is one of 15039 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Pentax Medical Company - FDA 510(k) Cleared Devices
Recent clearances: ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUS, PENTAX VIDEO BRONCHOSCOPES (EB FAMILY), PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)
12
Total
12
Cleared
0
Denied
Pentax Medical Company has 12 FDA 510(k) cleared medical devices. Based in Montvale, US.
Historical record: 12 cleared submissions from 2004 to 2014.
Browse the FDA 510(k) cleared devices submitted by Pentax Medical Company 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 Medical Company
12 devices
Cleared
Apr 25, 2014
ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUS
Ear, Nose, Throat
302d
Cleared
Apr 10, 2014
PENTAX VIDEO BRONCHOSCOPES (EB FAMILY)
Ear, Nose, Throat
363d
Cleared
Apr 10, 2014
PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)
Gastroenterology & Urology
289d
Cleared
Apr 09, 2014
PENTAX VIDEO COLONOSCOPES (EC FAMILY)
Gastroenterology & Urology
292d
Cleared
Dec 28, 2009
PENTEX EC-3890LI
Gastroenterology & Urology
90d
Cleared
Dec 02, 2009
PENTAX ED-3490TK, VIDEO DUODENOSCOPE
Gastroenterology & Urology
90d
Cleared
May 19, 2009
EG-3670URK
Radiology
112d
Cleared
May 19, 2009
EG-3870UTK
Radiology
112d
Cleared
Sep 05, 2008
ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK
Radiology
98d
Cleared
May 03, 2006
EG-3670URK
Radiology
16d
Cleared
Oct 19, 2004
ISC-1000 PENTAX CONFOCAL LASER SYSTEM
General & Plastic Surgery
15d
Cleared
Oct 19, 2004
EC-3870CILK, CONFOCAL VIDEO COLONOSCOPE
General & Plastic Surgery
15d