510k
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538
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1654
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360
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1323
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243
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957
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2175
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2038
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126
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97
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8
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462
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958
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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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155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
381
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358
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
284
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Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
209
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Orthofix Medical, Inc.
Medical Device Manufacturer
·
US , Lewisville , TX
Orthofix Medical, Inc. - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2024
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Orthofix Medical, Inc.
Orthopedic
✕
1
devices
1-1 of 1
Filters
Cleared
Jun 20, 2024
Reef TO/TA System
K240830
·
MAX
Orthopedic
·
86d
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