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901
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171
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1540
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Powered Laser Surgical Instrument
253
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System, Image Processing,...
234
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232
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221
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218
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217
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Orthopedic Stereotaxic Instrument
182
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Abutment, Implant, Dental,...
169
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Thoracolumbosacral Pedicle Screw...
150
MAX
Intervertebral Fusion Device...
146
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Instrumentarium Dental, Palodex Group OY
Medical Device Manufacturer
·
FI , Tuusula
Instrumentarium Dental, Palodex Group OY - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2007
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Instrumentarium Dental, Palodex Group OY
Radiology
✕
5
devices
1-5 of 5
Filters
Cleared
Mar 20, 2014
DIGORA OPTIME
K133231
·
MUH
Radiology
·
150d
Cleared
Oct 06, 2010
ORTHOPANTOMOGRAPH OP300
K093683
·
MUH
Radiology
·
310d
Cleared
Nov 20, 2009
ORTHOPANTOMOGRAPH OP30
K092591
·
MUH
Radiology
·
88d
Cleared
Sep 02, 2008
SNAPSHOT
K081925
·
MUH
Radiology
·
57d
Cleared
Jul 02, 2007
SIGMA M
K063837
·
MUH
Radiology
·
188d
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5
Radiology
5