510k
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545
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3023
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52
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515
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2486
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LZA
Polymer Patient Examination Glove
416
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399
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363
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358
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307
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304
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290
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Automated Radiological Image...
276
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Orthopedic Stereotaxic Instrument
236
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Intervertebral Fusion Device...
231
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Iweecare Co., Ltd.
Medical Device Manufacturer
·
TW , Taipei City
Iweecare Co., Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2021
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Iweecare Co., Ltd.
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Feb 17, 2023
Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1
K222588
·
FLL
General Hospital
·
175d
Cleared
Jul 22, 2021
Temp Pal
K202603
·
FLL
General Hospital
·
317d
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2
General Hospital
2