510k
Database
Specialties
Anesthesiology
540
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1672
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362
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1335
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245
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964
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2190
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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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2900
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52
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515
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2433
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155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
386
FXX
Mask, Surgical
358
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Powered Laser Surgical Instrument
356
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Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
270
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
219
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Aok Tooling Limited
Medical Device Manufacturer
·
CN , Shenzhen
Aok Tooling Limited - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2020
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Aok Tooling Limited
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 27, 2022
AOK 95A Medical Mask (20200049)
K220876
·
FXX
General Hospital
·
124d
Cleared
Nov 23, 2021
039 Surgical Face Mask
K211956
·
FXX
General Hospital
·
152d
Cleared
Sep 04, 2020
Plain Surgical Mask
K201517
·
FXX
General Hospital
·
88d
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3
General Hospital
3