510k
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337
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1072
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271
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819
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149
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634
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1331
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765
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100
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72
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1
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366
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587
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246
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155
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2059
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40
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310
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1589
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132
Categories
GEX
Powered Laser Surgical Instrument
231
HRS
Plate, Fixation, Bone
211
IYN
System, Imaging, Pulsed Doppler,...
209
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Automated Radiological Image...
207
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System, Image Processing,...
199
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Electrosurgical, Cutting &...
186
OLO
Orthopedic Stereotaxic Instrument
170
NHA
Abutment, Implant, Dental,...
160
MAX
Intervertebral Fusion Device...
138
NKB
Thoracolumbosacral Pedicle Screw...
136
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Promisemed Hangzhou Meditech Co., Ltd.
Medical Device Manufacturer
·
CN , Hangzhou
Promisemed Hangzhou Meditech Co., Ltd. - FDA 510(k) Cleared Devices
34 submissions
·
34 cleared
·
Since 2017
34
Total
34
Cleared
0
Denied
FDA 510(k) Regulatory Record - Promisemed Hangzhou Meditech Co., Ltd.
Gastroenterology & Urology
✕
2
devices
1-2 of 2
Filters
Cleared
Oct 04, 2024
Endoscopic Injection Needles
K240675
·
FBK
Gastroenterology & Urology
·
207d
Cleared
Jul 12, 2024
Single Use Hemoclips
K234124
·
PKL
Gastroenterology & Urology
·
197d
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34
General Hospital
24
General & Plastic Surgery
8
Gastroenterology & Urology
2