510k
Database
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Anesthesiology
449
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1364
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334
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1056
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194
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808
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1779
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1211
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121
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84
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7
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420
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767
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334
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211
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2423
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44
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408
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1974
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143
Categories
GEX
Powered Laser Surgical Instrument
290
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System, Image Processing,...
281
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Electrosurgical, Cutting &...
253
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Automated Radiological Image...
251
IYN
System, Imaging, Pulsed Doppler,...
241
HRS
Plate, Fixation, Bone
236
LZA
Polymer Patient Examination Glove
205
OLO
Orthopedic Stereotaxic Instrument
198
NHA
Abutment, Implant, Dental,...
187
MAX
Intervertebral Fusion Device...
167
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Mitsubishi Electronics America, Inc.
Medical Device Manufacturer
·
US , Conshohocken , PA
Mitsubishi Electronics America, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1997
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Mitsubishi Electronics America, Inc.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Jan 14, 1998
120 LEAF MULTILEAF COLLIMATOR
K973963
·
IYE
Radiology
·
90d
Cleared
May 12, 1997
DYNAMIC WEDGE
K970564
·
IYE
Radiology
·
88d
Cleared
Apr 15, 1997
EXL-12SP,12DP,15DP,20DP LINAC
K970137
·
IYE
Radiology
·
90d
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3
Radiology
3