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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LLZ
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
GEX
Powered Laser Surgical Instrument
520
LZA
Polymer Patient Examination Glove
489
JWH
Prosthesis, Knee,...
464
LNH
System, Nuclear Magnetic...
431
MAX
Intervertebral Fusion Device...
403
FXX
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.
General Hospital
✕
5
devices
1-5 of 5
Filters
Cleared
Oct 20, 1987
NUTRIPUMP
K872741
·
FRN
General Hospital
·
102d
Cleared
Dec 10, 1985
STERILE SALINE SOLUTION
K854155
·
KMJ
General Hospital
·
60d
Cleared
Oct 17, 1985
HUBOUT
K853287
·
FPA
General Hospital
·
73d
Cleared
Jan 10, 1984
SYRINGE
K833399
·
FMF
General Hospital
·
97d
Cleared
Dec 12, 1983
MULTI PURPOSE SYRINGE
K833435
·
FMF
General Hospital
·
68d
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41
Immunology
15
General & Plastic Surgery
12
General Hospital
5
Gastroenterology & Urology
3
Microbiology
3
Obstetrics & Gynecology
2
Neurology
1