510k
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540
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1660
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362
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1333
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244
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958
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2183
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2039
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126
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97
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8
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466
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962
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433
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274
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2868
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52
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515
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2428
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155
Categories
LZA
Polymer Patient Examination Glove
407
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System, Image Processing,...
383
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358
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
302
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System, Imaging, Pulsed Doppler,...
296
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Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
219
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Flashback Technologies, Inc.
Medical Device Manufacturer
·
US , Boulder , CO
Flashback Technologies, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
2 cleared
·
Since 2016
3
Total
2
Cleared
1
Denied
FDA 510(k) Regulatory Record - Flashback Technologies, Inc.
Cardiovascular
✕
3
devices
1-3 of 3
Filters
Cleared
Jun 17, 2022
CipherOx CRI Tablet
K213255
·
PPW
Cardiovascular
·
260d
Cleared
Jul 24, 2018
CipherOx CRI M1
K173929
·
PPW
Cardiovascular
·
210d
Not Cleared
Dec 21, 2016
CipherOx CRI Tablet
DEN160020
·
PPW
Cardiovascular
·
211d
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3
Cardiovascular
3