510k
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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
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
378
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357
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351
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Electrosurgical, Cutting &...
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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Artsmedia Denmark Aps
Medical Device Manufacturer
·
DK , Virum
Artsmedia Denmark Aps - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2023
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Artsmedia Denmark Aps
Obstetrics & Gynecology
✕
3
devices
1-3 of 3
Filters
Cleared
Dec 18, 2024
ARTSMedia Semen Wash Medium
K241095
·
MQL
Obstetrics & Gynecology
·
240d
Cleared
Dec 18, 2024
ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)
K241132
·
MQL
Obstetrics & Gynecology
·
238d
Cleared
Feb 10, 2023
ARTSMedia In Vitro Culture Medium (AM-IVC Medium)
K220715
·
MQL
Obstetrics & Gynecology
·
336d
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3
Obstetrics & Gynecology
3