510k
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1367
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334
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1058
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194
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808
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1780
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1214
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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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336
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211
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2426
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44
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410
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1977
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143
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Powered Laser Surgical Instrument
290
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281
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Electrosurgical, Cutting &...
253
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Automated Radiological Image...
251
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System, Imaging, Pulsed Doppler,...
241
HRS
Plate, Fixation, Bone
236
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Polymer Patient Examination Glove
206
OLO
Orthopedic Stereotaxic Instrument
198
NHA
Abutment, Implant, Dental,...
187
MAX
Intervertebral Fusion Device...
168
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Elscint Mr, Inc.
Medical Device Manufacturer
·
US , Fort Collins , CO
Elscint Mr, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1996
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Elscint Mr, Inc.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 15, 1997
ESTEEM 1.5T MRI SYSTEM
K972826
·
LNH
Radiology
·
78d
Cleared
Aug 25, 1997
GYREX PRIMA 1TG 1.0T MRI SYSTEM
K970990
·
LNH
Radiology
·
160d
Cleared
Sep 20, 1996
ESTEEM 1.5T MRI SYSTEM
K962677
·
LNH
Radiology
·
73d
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3
Radiology
3