510k
Database
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Anesthesiology
540
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1666
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362
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1334
Ear, Nose, Throat
245
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963
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2186
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2043
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126
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97
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8
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466
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965
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433
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274
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2886
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52
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515
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2431
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155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
384
FXX
Mask, Surgical
358
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Powered Laser Surgical Instrument
353
GEI
Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
270
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
219
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Theken Companies
Medical Device Manufacturer
·
US , Akron , OH
Theken Companies - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2022
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Theken Companies
Orthopedic
✕
1
devices
1-1 of 1
Filters
Cleared
Sep 30, 2022
Mg-PSZ Ceramic Femoral Head
K220336
·
LPH
Orthopedic
·
235d
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Orthopedic
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