510k
Database
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Anesthesiology
545
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1705
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378
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1351
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250
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981
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2215
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2065
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126
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100
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8
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474
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980
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439
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282
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2999
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52
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515
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2475
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155
Categories
LZA
Polymer Patient Examination Glove
415
LLZ
System, Image Processing,...
398
GEX
Powered Laser Surgical Instrument
363
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Mask, Surgical
358
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Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
303
HRS
Plate, Fixation, Bone
288
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
225
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Taiwan Medical Electronics Co., Ltd.
Medical Device Manufacturer
·
TW , Taipei City
Taiwan Medical Electronics Co., Ltd. - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2025
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Taiwan Medical Electronics Co., Ltd.
Physical Medicine
✕
1
devices
1-1 of 1
Filters
Cleared
Apr 01, 2025
STOPWET iontophoresis apparatus (SW01)
K242041
·
EGJ
Physical Medicine
·
263d
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Physical Medicine
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