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542
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1680
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365
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249
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2194
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2047
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126
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99
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469
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433
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279
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2937
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52
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515
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2444
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155
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LZA
Polymer Patient Examination Glove
409
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System, Image Processing,...
388
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Mask, Surgical
358
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Powered Laser Surgical Instrument
356
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Electrosurgical, Cutting &...
305
IYN
System, Imaging, Pulsed Doppler,...
299
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
275
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Iorbit Digital Technologies Private Limited
Medical Device Manufacturer
·
IN , Bangalore
Iorbit Digital Technologies Private Limited - FDA 510(k) Cleared Devi...
1 submissions
·
1 cleared
·
Since 2025
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Iorbit Digital Technologies Private Limited
Cardiovascular
✕
1
devices
1-1 of 1
Filters
Cleared
May 16, 2025
iBSM
K243837
·
DRG
Cardiovascular
·
154d
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Cardiovascular
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