510k
Database
Specialties
Anesthesiology
198
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720
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185
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449
Ear, Nose, Throat
86
Gastroenterology & Urology
382
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750
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460
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74
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61
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1
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271
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286
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111
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75
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1464
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26
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145
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1066
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93
Categories
IYN
System, Imaging, Pulsed Doppler,...
161
HRS
Plate, Fixation, Bone
150
OLO
Orthopedic Stereotaxic Instrument
128
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Powered Laser Surgical Instrument
122
LLZ
System, Image Processing,...
122
QIH
Automated Radiological Image...
106
GEI
Electrosurgical, Cutting &...
103
NHA
Abutment, Implant, Dental,...
103
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Hi-Care Thai Gloves Co. , Ltd.
Medical Device Manufacturer
·
TH , Hat Yai
Hi-Care Thai Gloves Co. , Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2020
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Hi-Care Thai Gloves Co. , Ltd.
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 02, 2020
Palm Care Blue Nitrile Examination Gloves Powder Free
K202384
·
LZA
General Hospital
·
104d
Cleared
Dec 01, 2020
Palm Care Latex Examination Powder Free Gloves
K202377
·
LYY
General Hospital
·
103d
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2
General Hospital
2