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540
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244
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2182
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126
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97
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464
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962
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433
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2862
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52
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515
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2418
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155
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Polymer Patient Examination Glove
407
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382
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358
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351
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302
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System, Imaging, Pulsed Doppler,...
288
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Automated Radiological Image...
276
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Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
219
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Claritas Healthtech Pte, Ltd.
Medical Device Manufacturer
·
SG , Singapore
Claritas Healthtech Pte, Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2021
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Claritas Healthtech Pte, Ltd.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Aug 05, 2025
iPETcertum (v1.0)
K244016
·
LLZ
Radiology
·
221d
Cleared
Dec 22, 2021
Claritas iPET
K213140
·
LLZ
Radiology
·
86d
Cleared
Oct 20, 2021
iRAD
K212470
·
LLZ
Radiology
·
75d
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3
Radiology
3