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2886
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Polymer Patient Examination Glove
408
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384
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358
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353
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302
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System, Imaging, Pulsed Doppler,...
296
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Automated Radiological Image...
276
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Plate, Fixation, Bone
270
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Orthopedic Stereotaxic Instrument
226
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Intervertebral Fusion Device...
219
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Ignite Orthomotion
Medical Device Manufacturer
·
US , Winona Lake , IN
Ignite Orthomotion - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2024
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ignite Orthomotion
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Sep 02, 2025
Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component
K251975
·
NJD
Orthopedic
·
68d
Cleared
Dec 16, 2024
ACHIEVE Partial Knee System
K242307
·
NJD
Orthopedic
·
133d
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Orthopedic
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