510k
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Anesthesiology
694
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2130
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468
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1719
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309
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1220
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2674
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2404
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152
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135
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13
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578
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1205
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554
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365
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3782
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57
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574
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3002
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172
Categories
LLZ
System, Image Processing,...
500
LZA
Polymer Patient Examination Glove
452
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Powered Laser Surgical Instrument
436
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Electrosurgical, Cutting &...
393
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Mask, Surgical
387
IYN
System, Imaging, Pulsed Doppler,...
360
HRS
Plate, Fixation, Bone
348
MAX
Intervertebral Fusion Device...
307
OLO
Orthopedic Stereotaxic Instrument
286
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Automated Radiological Image...
285
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Manufacturers
US
Irvine Scientific
Medical Device Manufacturer
·
US , Mchenry , IL
Irvine Scientific - FDA 510(k) Cleared Devices
16 submissions
·
16 cleared
·
Since 1982
16
Total
16
Cleared
0
Denied
FDA 510(k) Regulatory Record - Irvine Scientific
Chemistry
✕
5
devices
1-5 of 5
Filters
Cleared
Jul 15, 1985
SPINAL FLUID CONTROL
K851820
·
JJY
Chemistry
·
80d
Cleared
Jul 13, 1982
LEVEL I LIPID CONTROL
K821559
·
JJY
Chemistry
·
49d
Cleared
Jul 13, 1982
LEVEL II LIPID CONTROL
K821560
·
JJY
Chemistry
·
49d
Cleared
Jul 08, 1982
LEVEL I CONTROL SERUM
K821557
·
JJY
Chemistry
·
44d
Cleared
Jul 02, 1982
LEVEL II CONTROL SERUM
K821558
·
JJX
Chemistry
·
38d
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16
Obstetrics & Gynecology
11
Chemistry
5