510k
Database
Specialties
Anesthesiology
204
Cardiovascular
739
Chemistry
187
Dental
465
Ear, Nose, Throat
91
Gastroenterology & Urology
394
General & Plastic Surgery
772
General Hospital
475
Hematology
77
Immunology
64
Medical Genetics
1
Microbiology
277
Neurology
301
Obstetrics & Gynecology
116
Ophthalmic
78
Orthopedic
1477
Pathology
26
Physical Medicine
152
Radiology
1091
Toxicology
93
Categories
IYN
System, Imaging, Pulsed Doppler,...
167
HRS
Plate, Fixation, Bone
151
OLO
Orthopedic Stereotaxic Instrument
131
GEX
Powered Laser Surgical Instrument
126
LLZ
System, Image Processing,...
124
QIH
Automated Radiological Image...
111
NHA
Abutment, Implant, Dental,...
105
GEI
Electrosurgical, Cutting &...
105
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Pentax Medical
Medical Device Manufacturer
·
US , Montvale , NJ
Pentax Medical - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 2013
6
Total
6
Cleared
0
Denied
FDA 510(k) cleared devices by Pentax Medical
Ear, Nose, Throat
✕
2
devices
1-2 of 2
Filters
Cleared
Jul 18, 2018
PENTAX Medical VIVIDEO ENT Videoscope Solution
K171011
·
EOB
Ear, Nose, Throat
·
470d
Cleared
Apr 05, 2018
PENTAX Medical EPK-3000 Video Imaging System
K172156
·
EOB
Ear, Nose, Throat
·
261d
Filters
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6
Gastroenterology & Urology
4
Ear, Nose, Throat
2