510k
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531
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1642
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359
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1314
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242
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954
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2166
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2031
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126
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97
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462
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433
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274
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2819
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52
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515
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2400
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155
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LZA
Polymer Patient Examination Glove
407
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379
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357
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
299
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System, Imaging, Pulsed Doppler,...
283
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Automated Radiological Image...
275
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Plate, Fixation, Bone
269
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Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
208
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Chirana T. Injecta
Medical Device Manufacturer
·
SK , Star? Tur?
Chirana T. Injecta - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2021
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Chirana T. Injecta
General Hospital
✕
4
devices
1-4 of 4
Filters
Cleared
Dec 24, 2024
Insulin Syringes
K242434
·
FMF
General Hospital
·
130d
Cleared
Jun 15, 2022
MEDOJECT fine Pen Needles
K220614
·
FMI
General Hospital
·
104d
Cleared
Jan 18, 2022
CHIRANA Insulin Syringes
K201044
·
FMF
General Hospital
·
637d
Cleared
Jul 21, 2021
CHIRAVAC Blood Collection Needles
K201009
·
JKA
General Hospital
·
460d
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4
General Hospital
4