Medical Device Manufacturer · US , Mchenry , IL

Pentax Precision Instrument Corp. - FDA 510(k) Cleared Devices

67 submissions · 67 cleared · Since 1979
67
Total
67
Cleared
0
Denied
67 devices
26-50 of 67
Cleared Jun 29, 1995
FS-34P2, FIBER SIGMOIDOSCOPE
K951576 · FAM
Gastroenterology & Urology · 86d
Cleared Jun 27, 1995
FS-38X, FIBER SIGMOIDOSCOPE
K951572 · FAM
Gastroenterology & Urology · 84d
Cleared Jun 27, 1995
FS-38H, FIBER SIGMOIDOSCOPE
K951573 · FAM
Gastroenterology & Urology · 84d
Cleared Jun 27, 1995
FC-38TLH, FIBER COLONOSCOPE
K951575 · FDF
Gastroenterology & Urology · 84d
Cleared Jun 27, 1995
FC-38LX, FIBER COLONOSCOPE
K951578 · FDF
Gastroenterology & Urology · 84d
Cleared Jun 27, 1995
FC-38LH, FIBER COLONOSCCOPE
K951580 · FDF
Gastroenterology & Urology · 84d
Cleared Jun 02, 1995
PENTAX FACE MASK
K933683 · FXX
General Hospital · 673d
Cleared May 30, 1995
FCN-15X, FIBER CHOLEDOCHONEPHROSCOPE
K951191 · FBN
Gastroenterology & Urology · 75d
Cleared May 30, 1995
FE-24X, FIBER ESOPHAGOSCOPE
K951197 · GCL
Gastroenterology & Urology · 75d
Cleared May 30, 1995
FE-34TH, FIBER ESOPHAGOSCOPE
K951198 · GCL
Gastroenterology & Urology · 75d
Cleared Apr 10, 1995
FB-18X, FIBER BRONCHOSCOPE
K951199 · EOQ
Ear, Nose, Throat · 25d
Cleared Apr 07, 1995
FNL-10P, FIBER NASOPARHYNGOSCOPE
K951196 · EOB
Ear, Nose, Throat · 22d
Cleared Apr 06, 1995
FI-10M
K951194 · CAL
Anesthesiology · 21d
Cleared Apr 06, 1995
FI-10P
K951195 · CAL
Anesthesiology · 21d
Cleared Feb 07, 1994
EPM-3300 VIDEO PROCESSOR
K934918 · FET
Gastroenterology & Urology · 115d
Cleared Jan 26, 1994
VB-1830/VB-1530, VIDEO BRONCHOSCOPE
K934920 · EOQ
Ear, Nose, Throat · 103d
Cleared Jun 25, 1993
PENTAX XENON LIGHT SOURCE
K921315 · GCT
Gastroenterology & Urology · 464d
Cleared Jul 01, 1992
PENTAX NASO-PHARYNGO-LARYNGOSCOPE FNL-15P2/15RP2
K921707 · EOB
Ear, Nose, Throat · 82d
Cleared Jan 23, 1992
METAL HALIDE LIGHT SOURCE MODEL LM 250
K915274 · FST
General & Plastic Surgery · 59d
Cleared Jan 10, 1992
PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P
K914008 · FAJ
Gastroenterology & Urology · 123d
Cleared Jan 10, 1992
PENTAX URETERORENOFIBERSCOPE, MODEL FUR-10P
K914106 · FGB
Gastroenterology & Urology · 119d
Cleared Jun 12, 1991
PENTAX ULTRASOUND ENDOSCOPE, MODEL FG-32UA
K904573 · ODG
Radiology · 246d
Cleared Jul 09, 1985
PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23
K850020 · FDS
Gastroenterology & Urology · 186d
Cleared Feb 04, 1984
TWO CHANNEL GASTROFIBERSCOPE FG-36T
K833924 · FDS
Gastroenterology & Urology · 82d
Cleared Sep 20, 1983
LARYNGOTELESCOPE CURVED MLC-1
K832449 · EOQ
Ear, Nose, Throat · 57d
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