510k
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1945
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422
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279
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142
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111
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511
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1098
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3377
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556
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2771
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451
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Polymer Patient Examination Glove
434
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403
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384
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Electrosurgical, Cutting &...
357
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System, Imaging, Pulsed Doppler,...
331
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Plate, Fixation, Bone
316
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Automated Radiological Image...
284
MAX
Intervertebral Fusion Device...
257
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Orthopedic Stereotaxic Instrument
256
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Manufacturers
US
Paragon Medical
Medical Device Manufacturer
·
US , Pierceton , IN
Paragon Medical - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2018
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Paragon Medical
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Jun 13, 2019
Sonopet iQ Sterilization Tray
K190667
·
KCT
General Hospital
·
90d
Cleared
May 07, 2019
Stryker ChestShield Sterilization Tray System
K183701
·
KCT
General Hospital
·
127d
Cleared
Apr 18, 2018
Stryker Universal Select Sterilization Tray System
K173615
·
KCT
General Hospital
·
147d
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3
General Hospital
3