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243
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2176
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2038
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126
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97
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462
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433
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2838
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52
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515
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2413
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Polymer Patient Examination Glove
407
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382
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358
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351
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301
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System, Imaging, Pulsed Doppler,...
284
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Automated Radiological Image...
276
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Plate, Fixation, Bone
269
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Orthopedic Stereotaxic Instrument
226
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Intervertebral Fusion Device...
213
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Monarch Medical Technologies, LLC
Medical Device Manufacturer
·
US , Charlotte , NC
Monarch Medical Technologies, LLC - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2020
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Monarch Medical Technologies, LLC
Chemistry
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 28, 2021
EndoTool SubQ 2.1
K211160
·
NDC
Chemistry
·
192d
Cleared
Aug 07, 2020
EndoTool IV System
K201619
·
NDC
Chemistry
·
53d
Cleared
Mar 17, 2020
EndoTool IV 1.10
K200443
·
NDC
Chemistry
·
22d
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3
Chemistry
3