510k
Database
Specialties
Anesthesiology
548
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1719
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381
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1367
Ear, Nose, Throat
252
Gastroenterology & Urology
982
General & Plastic Surgery
2217
General Hospital
2088
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126
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101
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8
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474
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980
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441
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283
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3046
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52
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515
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2492
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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 &...
307
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 Konmed Technology Co., Ltd.
Medical Device Manufacturer
·
CN , Shenzhen
Shenzhen Konmed Technology Co., Ltd. - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 2018
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Shenzhen Konmed Technology Co., Ltd.
Neurology
✕
2
devices
1-2 of 2
Filters
Cleared
Jan 10, 2018
Electrodes with snap / Electrodes with pigtail
K171722
·
GXY
Neurology
·
212d
Cleared
Jan 05, 2018
Electrodes with silver conductive
K171721
·
GXY
Neurology
·
207d
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Gastroenterology & Urology
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Neurology
2
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