Medical Device Manufacturer · US , Montvale , NJ

Pentax Medical Company - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 2004
12
Total
12
Cleared
0
Denied
FDA 510(k) Regulatory Record - Pentax Medical Company Ear, Nose, Throat ✕
2 devices
1-2 of 2
Cleared Apr 25, 2014
ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUS
K131946 · EOQ
Ear, Nose, Throat · 302d
Cleared Apr 10, 2014
PENTAX VIDEO BRONCHOSCOPES (EB FAMILY)
K131028 · EOQ
Ear, Nose, Throat · 363d
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All12 Gastroenterology & Urology 4 Radiology 4 General & Plastic Surgery 2 Ear, Nose, Throat 2