510k
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Anesthesiology
534
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1649
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359
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1323
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243
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956
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2174
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2038
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126
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97
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8
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462
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954
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433
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274
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2828
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52
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515
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2403
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155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
381
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Mask, Surgical
358
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
275
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Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
209
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Hcmed Innovations Co., Ltd.
Medical Device Manufacturer
·
TW , Taipei City
Hcmed Innovations Co., Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2021
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hcmed Innovations Co., Ltd.
Anesthesiology
✕
2
devices
1-2 of 2
Filters
Cleared
Jun 20, 2025
AdheResp Smart Breath-actuated Mesh Nebulizer
K250583
·
CAF
Anesthesiology
·
113d
Cleared
Jul 01, 2021
Pulmogine Vibrating Mesh Nebulizer
K202171
·
CAF
Anesthesiology
·
332d
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Anesthesiology
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