510k
Database
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Anesthesiology
540
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1660
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362
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1323
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244
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957
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2179
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2039
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126
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97
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8
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464
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960
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433
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274
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2846
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52
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515
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2417
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155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
382
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Mask, Surgical
358
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
301
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System, Imaging, Pulsed Doppler,...
288
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Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
214
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Manteia Technologies Co., Ltd.
Medical Device Manufacturer
·
CN , Xiamen
Manteia Technologies Co., Ltd. - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 2023
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Manteia Technologies Co., Ltd.
Radiology
✕
6
devices
1-6 of 6
Filters
Cleared
Jan 23, 2026
AccuContour 4.0
K251351
·
QKB
Radiology
·
268d
Cleared
Dec 05, 2025
ARTAssistant
K250780
·
QKB
Radiology
·
266d
Cleared
Oct 24, 2025
AccuCheck
K250696
·
IYE
Radiology
·
231d
Cleared
Jul 20, 2023
AccuCheck
K223834
·
IYE
Radiology
·
210d
Cleared
Jul 10, 2023
MOZI TPS
K223724
·
MUJ
Radiology
·
209d
Cleared
Mar 09, 2023
AccuContour
K221706
·
QKB
Radiology
·
269d
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6
Radiology
6