510k
Database
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568
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1778
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394
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1440
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261
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1023
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2306
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2136
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132
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106
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8
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482
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1030
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471
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301
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3166
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52
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529
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2573
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159
Categories
LZA
Polymer Patient Examination Glove
428
LLZ
System, Image Processing,...
411
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Powered Laser Surgical Instrument
378
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Mask, Surgical
363
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Electrosurgical, Cutting &...
325
IYN
System, Imaging, Pulsed Doppler,...
309
HRS
Plate, Fixation, Bone
302
QIH
Automated Radiological Image...
280
OLO
Orthopedic Stereotaxic Instrument
246
MAX
Intervertebral Fusion Device...
245
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Manufacturers
US
Projects IN Health
Medical Device Manufacturer
·
US , Mchenry , IL
Projects IN Health - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1977
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Projects IN Health
Neurology
✕
1
devices
1-1 of 1
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Cleared
Apr 04, 1978
PINWHEEL
K780422
·
GWY
Neurology
·
18d
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3
Anesthesiology
2
Neurology
1