510k
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Anesthesiology
540
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1660
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362
Dental
1329
Ear, Nose, Throat
244
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957
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2182
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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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962
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433
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274
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2862
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52
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515
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2418
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155
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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 &...
302
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System, Imaging, Pulsed Doppler,...
288
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
219
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Achimhai Medical Corporation
Medical Device Manufacturer
·
KR , Hwaseong-Si
Achimhai Medical Corporation - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2017
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Achimhai Medical Corporation
Dental
✕
3
devices
1-3 of 3
Filters
Cleared
Aug 06, 2021
Kisses Plus Implant System
K200193
·
NHA
Dental
·
557d
Cleared
Apr 03, 2018
Kisses Plus Implant System
K172630
·
DZE
Dental
·
214d
Cleared
Oct 06, 2017
Kisses Mini
K170394
·
DZE
Dental
·
240d
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3
Dental
3