510k
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1191
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164
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1502
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108
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172
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2182
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353
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1737
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136
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Powered Laser Surgical Instrument
252
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229
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224
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221
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216
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209
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Orthopedic Stereotaxic Instrument
181
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Abutment, Implant, Dental,...
169
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Thoracolumbosacral Pedicle Screw...
148
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Intervertebral Fusion Device...
146
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Viztek, LLC
Medical Device Manufacturer
·
US , Naples , FL
Viztek, LLC - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 2011
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Viztek, LLC
Radiology
✕
6
devices
1-6 of 6
Filters
Cleared
May 20, 2016
ViZion DR + Wireless
K160810
·
MQB
Radiology
·
57d
Cleared
Sep 10, 2015
ViZion DR + Wireless
K152279
·
MQB
Radiology
·
29d
Cleared
Dec 16, 2014
EXA
K142919
·
LLZ
Radiology
·
69d
Cleared
Apr 03, 2014
VIZION ULTRA
K133139
·
MQB
Radiology
·
168d
Cleared
Jan 11, 2013
VIZION + DR
K123644
·
MQB
Radiology
·
46d
Cleared
Oct 20, 2011
VIZION DR
K112661
·
MQB
Radiology
·
37d
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Radiology
6