510k
Database
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Anesthesiology
341
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1091
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277
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832
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150
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647
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1351
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790
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100
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72
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371
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595
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252
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160
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2078
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40
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318
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1625
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132
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GEX
Powered Laser Surgical Instrument
234
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System, Imaging, Pulsed Doppler,...
213
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211
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211
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System, Image Processing,...
202
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Electrosurgical, Cutting &...
187
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Orthopedic Stereotaxic Instrument
171
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Abutment, Implant, Dental,...
162
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Thoracolumbosacral Pedicle Screw...
139
MAX
Intervertebral Fusion Device...
138
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Guangzhou Heygears IMC., Inc.
Medical Device Manufacturer
·
CN , Guangzhou
Guangzhou Heygears IMC., Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2022
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Guangzhou Heygears IMC., Inc.
Dental
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 02, 2026
UltraPrint-Dental Hard Splint UV
K253798
·
MQC
Dental
·
94d
Cleared
Nov 20, 2025
UltraPrint-Dental Denture UV
K253324
·
EBI
Dental
·
51d
Cleared
Jan 14, 2022
UltraPrint-Dental Temp C&B UV
K213643
·
EBG
Dental
·
57d
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3
Dental
3