510k
Database
Specialties
Anesthesiology
204
Cardiovascular
734
Chemistry
187
Dental
461
Ear, Nose, Throat
91
Gastroenterology & Urology
391
General & Plastic Surgery
767
General Hospital
473
Hematology
77
Immunology
63
Medical Genetics
1
Microbiology
274
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296
Obstetrics & Gynecology
114
Ophthalmic
76
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1474
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26
Physical Medicine
152
Radiology
1083
Toxicology
93
Categories
IYN
System, Imaging, Pulsed Doppler,...
167
HRS
Plate, Fixation, Bone
151
OLO
Orthopedic Stereotaxic Instrument
130
GEX
Powered Laser Surgical Instrument
125
LLZ
System, Image Processing,...
123
QIH
Automated Radiological Image...
109
GEI
Electrosurgical, Cutting &...
105
NHA
Abutment, Implant, Dental,...
104
MAX
Intervertebral Fusion Device...
96
NKB
Thoracolumbosacral Pedicle Screw...
93
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Katalyst, Inc.
Medical Device Manufacturer
·
US , Seattle , WA
Katalyst, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2017
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Katalyst, Inc.
Physical Medicine
✕
3
devices
1-3 of 3
Filters
Cleared
Feb 03, 2020
Katalyst Training System
K190966
·
NGX
Physical Medicine
·
297d
Cleared
Sep 20, 2018
Katalyst Mark 1 Muscle Stimulation System Model 2
K181199
·
NGX
Physical Medicine
·
136d
Cleared
Sep 06, 2017
Katalyst Mark 1 Muscle Stimulation System
K171035
·
NGX
Physical Medicine
·
153d
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3
Physical Medicine
3