510k
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204
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736
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187
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465
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91
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391
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768
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473
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77
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63
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275
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296
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115
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77
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1475
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26
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152
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1083
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93
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IYN
System, Imaging, Pulsed Doppler,...
167
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Plate, Fixation, Bone
151
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Orthopedic Stereotaxic Instrument
130
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Powered Laser Surgical Instrument
125
LLZ
System, Image Processing,...
123
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Automated Radiological Image...
109
GEI
Electrosurgical, Cutting &...
105
NHA
Abutment, Implant, Dental,...
105
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Shatkin F.I.R.S.T., LLC
Medical Device Manufacturer
·
US , Amherst , NY
Shatkin F.I.R.S.T., LLC - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2019
1
Total
1
Cleared
0
Denied
FDA 510(k) cleared devices by Shatkin F.I.R.S.T., LLC
Dental
✕
1
devices
1-1 of 1
Filters
Cleared
Dec 19, 2019
Krystal Klear Aligners
K182388
·
NXC
Dental
·
471d
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1
Dental
1