510k
Database
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534
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1649
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359
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1323
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243
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956
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2174
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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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954
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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
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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
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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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Ziehm-Orthoscan, Inc.
Medical Device Manufacturer
·
US , Scottsdale , AZ
Ziehm-Orthoscan, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2025
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ziehm-Orthoscan, Inc.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Jan 14, 2026
Orthoscan TAU MVP Mini C-Arm System
K252579
·
OXO
Radiology
·
152d
Cleared
Jul 02, 2025
Orthoscan TAU Mini C-Arm
K250587
·
OXO
Radiology
·
125d
Cleared
Jan 14, 2025
Orthoscan VERSA Mini C-Arm
K243452
·
OXO
Radiology
·
68d
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3
Radiology
3