510k
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Specialties
Anesthesiology
545
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1699
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374
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1351
Ear, Nose, Throat
250
Gastroenterology & Urology
979
General & Plastic Surgery
2213
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2062
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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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438
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282
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2988
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52
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515
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2468
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155
Categories
LZA
Polymer Patient Examination Glove
414
LLZ
System, Image Processing,...
398
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Powered Laser Surgical Instrument
363
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Mask, Surgical
358
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Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
284
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
224
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Shenzhen Ionka Medical Technology Co., Ltd.
Medical Device Manufacturer
·
CN , Shenzhen
Shenzhen Ionka Medical Technology Co., Ltd. - FDA 510(k) Cleared Devi...
2 submissions
·
2 cleared
·
Since 2022
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Shenzhen Ionka Medical Technology Co., Ltd.
General & Plastic Surgery
✕
2
devices
1-2 of 2
Filters
Cleared
May 26, 2023
Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608,...
K230739
·
OHT
General & Plastic Surgery
·
70d
Cleared
Sep 21, 2022
Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608,...
K221214
·
ONF
General & Plastic Surgery
·
147d
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General & Plastic Surgery
2