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1646
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359
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243
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2174
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2038
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126
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97
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462
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953
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433
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274
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2828
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52
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515
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2403
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Polymer Patient Examination Glove
407
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381
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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...
275
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Plate, Fixation, Bone
269
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Orthopedic Stereotaxic Instrument
226
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Intervertebral Fusion Device...
209
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Plus EV Holdings Dba Intimate Rose
Medical Device Manufacturer
·
US , North Kansas City , MO
Plus EV Holdings Dba Intimate Rose - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2020
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Plus EV Holdings Dba Intimate Rose
Obstetrics & Gynecology
✕
3
devices
1-3 of 3
Filters
Cleared
Aug 14, 2024
Intimate Rose Vaginal Dilators
K241748
·
HDX
Obstetrics & Gynecology
·
57d
Cleared
Jun 07, 2023
Intimate Rose Vaginal Dilators
K231430
·
HDX
Obstetrics & Gynecology
·
21d
Cleared
Aug 24, 2020
Intimate Rose Kegel Exercise System
K193364
·
HIR
Obstetrics & Gynecology
·
264d
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3
Obstetrics & Gynecology
3