510k
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550
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1729
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386
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1400
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257
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994
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2237
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2097
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127
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104
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8
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474
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985
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444
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286
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3076
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52
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515
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2510
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156
Categories
LZA
Polymer Patient Examination Glove
422
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System, Image Processing,...
401
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Powered Laser Surgical Instrument
366
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359
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Electrosurgical, Cutting &...
312
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System, Imaging, Pulsed Doppler,...
305
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Plate, Fixation, Bone
300
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Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
237
MAX
Intervertebral Fusion Device...
234
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Crystalvue Medical Corporation
Medical Device Manufacturer
·
TW , Taoyuan City
Crystalvue Medical Corporation - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2018
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Crystalvue Medical Corporation
Ophthalmic
✕
3
devices
1-3 of 3
Filters
Cleared
Apr 13, 2021
NFC-600 Automated Portable Retinal Camera
K210197
·
HKI
Ophthalmic
·
78d
Cleared
Jan 02, 2019
NFC-700 non-mydriatic auto fundus camera
K182199
·
HKI
Ophthalmic
·
141d
Cleared
Dec 14, 2018
Tono Vue Non-Contact Tonometer
K180820
·
HKX
Ophthalmic
·
260d
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3
Ophthalmic
3