510k
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538
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1656
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360
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1323
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243
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957
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2176
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2038
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126
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97
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8
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462
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959
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433
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274
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2838
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52
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515
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2413
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155
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LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
382
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358
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
213
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Monarch Medical Technologies
Medical Device Manufacturer
·
US , Silver Spring , MD
Monarch Medical Technologies - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2014
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Monarch Medical Technologies
Chemistry
✕
1
devices
1-1 of 1
Filters
Cleared
Dec 11, 2024
EndoTool IV (3.1)
K241088
·
NDC
Chemistry
·
236d
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3
General Hospital
2
Chemistry
1