510k
Database
Specialties
Anesthesiology
550
Cardiovascular
1722
Chemistry
385
Dental
1379
Ear, Nose, Throat
252
Gastroenterology & Urology
985
General & Plastic Surgery
2224
General Hospital
2088
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127
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101
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8
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474
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983
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441
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283
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3050
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52
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515
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2497
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155
Categories
LZA
Polymer Patient Examination Glove
416
LLZ
System, Image Processing,...
401
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Powered Laser Surgical Instrument
363
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Mask, Surgical
359
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Electrosurgical, Cutting &...
310
IYN
System, Imaging, Pulsed Doppler,...
304
HRS
Plate, Fixation, Bone
297
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
236
MAX
Intervertebral Fusion Device...
233
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Shenzhen Mareal Tech Co., Ltd.
Medical Device Manufacturer
·
CN , Shenzhen
Shenzhen Mareal Tech Co., Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2018
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Shenzhen Mareal Tech Co., Ltd.
General & Plastic Surgery
✕
2
devices
1-2 of 2
Filters
Cleared
Jul 01, 2022
Home use hair removal device
K220248
·
OHT
General & Plastic Surgery
·
151d
Cleared
Feb 12, 2018
Home Use Hair Removal Device/T1, T2, T3
K172883
·
OHT
General & Plastic Surgery
·
144d
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General & Plastic Surgery
2