510k
Database
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531
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1642
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359
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1314
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242
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953
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2165
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2031
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126
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97
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8
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462
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950
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433
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274
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2812
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52
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515
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2386
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155
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LZA
Polymer Patient Examination Glove
407
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378
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357
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351
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298
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System, Imaging, Pulsed Doppler,...
280
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Automated Radiological Image...
275
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Plate, Fixation, Bone
269
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Orthopedic Stereotaxic Instrument
224
MAX
Intervertebral Fusion Device...
208
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Reprise Biomedical, Inc.
Medical Device Manufacturer
·
US , Plymouth , MN
Reprise Biomedical, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2022
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Reprise Biomedical, Inc.
General & Plastic Surgery
✕
4
devices
1-4 of 4
Filters
Cleared
Apr 19, 2024
Miro3D Fibers Wound Matrix
K240753
·
KGN
General & Plastic Surgery
·
30d
Cleared
Mar 01, 2024
MiroDry Wound Matrix
K240277
·
KGN
General & Plastic Surgery
·
30d
Cleared
Dec 13, 2023
MiroTract Wound Matrix
K231614
·
KGN
General & Plastic Surgery
·
194d
Cleared
Aug 18, 2022
Miro3D Wound Matrix
K221520
·
KGN
General & Plastic Surgery
·
85d
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4
General & Plastic Surgery
4