510k
Database
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Anesthesiology
540
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1672
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362
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1335
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245
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964
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2190
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2043
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126
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97
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8
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466
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965
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433
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274
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2900
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52
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515
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2433
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155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
386
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Mask, Surgical
358
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Powered Laser Surgical Instrument
356
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Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
270
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
219
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Starmed Co., Ltd.
Medical Device Manufacturer
·
KR , Gyeonggi-Do
Starmed Co., Ltd. - FDA 510(k) Cleared Devices
10 submissions
·
10 cleared
·
Since 2017
10
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Starmed Co., Ltd.
Gastroenterology & Urology
✕
2
devices
1-2 of 2
Filters
Cleared
Oct 25, 2023
ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L,...
K233113
·
KNS
Gastroenterology & Urology
·
28d
Cleared
Apr 11, 2019
ELRA Electrode
K181758
·
KNS
Gastroenterology & Urology
·
283d
Filters
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10
General & Plastic Surgery
8
Gastroenterology & Urology
2