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386
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2232
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104
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3064
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515
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2505
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156
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Polymer Patient Examination Glove
418
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401
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365
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359
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310
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System, Imaging, Pulsed Doppler,...
305
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Plate, Fixation, Bone
298
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Automated Radiological Image...
277
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Orthopedic Stereotaxic Instrument
236
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Intervertebral Fusion Device...
234
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Sturdy Industrial Co., Ltd.
Medical Device Manufacturer
·
US , Plano , TX
Sturdy Industrial Co., Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2004
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sturdy Industrial Co., Ltd.
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Jun 21, 2023
Sturdy Autoclave Super Microm
K231489
·
FLE
General Hospital
·
29d
Cleared
Nov 01, 2019
STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R)
K181993
·
FLE
General Hospital
·
463d
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3
General Hospital
2
Anesthesiology
1