510k
Database
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Anesthesiology
550
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1727
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386
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1394
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256
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992
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2235
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2093
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127
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104
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8
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474
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985
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444
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286
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3071
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52
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515
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2508
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156
Categories
LZA
Polymer Patient Examination Glove
418
LLZ
System, Image Processing,...
401
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Powered Laser Surgical Instrument
366
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Mask, Surgical
359
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Electrosurgical, Cutting &...
310
IYN
System, Imaging, Pulsed Doppler,...
305
HRS
Plate, Fixation, Bone
299
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
236
MAX
Intervertebral Fusion Device...
234
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Sigma Medical Supplies Corporation
Medical Device Manufacturer
·
TW , New Taipei City
Sigma Medical Supplies Corporation - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2018
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sigma Medical Supplies Corporation
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 23, 2021
SIGMA Sterilization Pouch and Roll
K202462
·
FRG
General Hospital
·
239d
Cleared
Jun 06, 2018
Sterilization Pouch/Roll Made with Tyvek
K180672
·
FRG
General Hospital
·
84d
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2
General Hospital
2