510k
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1091
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4422
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3258
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2793
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468
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2426
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4114
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3829
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805
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782
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15
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1726
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1772
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882
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497
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7544
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166
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963
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4747
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1239
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System, Image Processing,...
730
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Plate, Fixation, Bone
689
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Electrosurgical, Cutting &...
568
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System, Imaging, Pulsed Doppler,...
533
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Powered Laser Surgical Instrument
520
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Polymer Patient Examination Glove
489
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Prosthesis, Knee,...
464
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System, Nuclear Magnetic...
431
MAX
Intervertebral Fusion Device...
403
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Mask, Surgical
400
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Manufacturers
US
I M, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
I M, Inc. - FDA 510(k) Cleared Devices
41 submissions
·
40 cleared
·
Since 1976
41
Total
40
Cleared
0
Denied
FDA 510(k) Regulatory Record - I M, Inc.
Microbiology
✕
3
devices
1-3 of 3
Filters
Cleared
Feb 01, 1979
REAGENT, COCCI LATEX
K782070
·
GMG
Microbiology
·
51d
Cleared
Apr 28, 1978
CRYPTOCOCCAL ANTIGEN LATEX AGG. SYSTEM
K780526
·
GMD
Microbiology
·
28d
Cleared
Mar 17, 1978
CANDIDA IMMUNODIFFUSION KIT
K770527
·
GMI
Microbiology
·
364d
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41
Immunology
15
General & Plastic Surgery
12
General Hospital
5
Microbiology
3
Gastroenterology & Urology
3
Obstetrics & Gynecology
2
Neurology
1