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 General & Plastic Surgery ✕
2 devices
1-2 of 2
Cleared Oct 19, 2004
ISC-1000 PENTAX CONFOCAL LASER SYSTEM
K042740 · GCJ
General & Plastic Surgery · 15d
Cleared Oct 19, 2004
EC-3870CILK, CONFOCAL VIDEO COLONOSCOPE
K042741 · GCJ
General & Plastic Surgery · 15d
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All12 Gastroenterology & Urology 4 Radiology 4 General & Plastic Surgery 2 Ear, Nose, Throat 2