510k
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Anesthesiology
204
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736
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187
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465
Ear, Nose, Throat
91
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392
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769
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474
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77
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63
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1
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275
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297
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115
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77
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1476
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26
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152
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1084
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93
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IYN
System, Imaging, Pulsed Doppler,...
167
HRS
Plate, Fixation, Bone
151
OLO
Orthopedic Stereotaxic Instrument
130
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Powered Laser Surgical Instrument
125
LLZ
System, Image Processing,...
123
QIH
Automated Radiological Image...
109
NHA
Abutment, Implant, Dental,...
105
GEI
Electrosurgical, Cutting &...
105
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Cathworks, Ltd.
Medical Device Manufacturer
·
IL , Kfar-Saba
Cathworks, Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2018
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Cathworks, Ltd.
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 09, 2019
FFRangio
K192442
·
QEK
Cardiovascular
·
94d
Cleared
Dec 19, 2018
FFRangio System
K182149
·
QEK
Cardiovascular
·
133d
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Cardiovascular
2