510k
Database
Specialties
Anesthesiology
207
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742
Chemistry
187
Dental
472
Ear, Nose, Throat
92
Gastroenterology & Urology
398
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783
General Hospital
479
Hematology
77
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64
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1
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277
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309
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121
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81
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1483
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26
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155
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1102
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95
Categories
IYN
System, Imaging, Pulsed Doppler,...
168
HRS
Plate, Fixation, Bone
151
OLO
Orthopedic Stereotaxic Instrument
131
GEX
Powered Laser Surgical Instrument
128
LLZ
System, Image Processing,...
126
QIH
Automated Radiological Image...
113
GEI
Electrosurgical, Cutting &...
105
NHA
Abutment, Implant, Dental,...
105
MAX
Intervertebral Fusion Device...
97
NKB
Thoracolumbosacral Pedicle Screw...
93
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Kem Medical Products Corp.
Medical Device Manufacturer
·
US , Mchenry , IL
Kem Medical Products Corp. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1980
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Kem Medical Products Corp.
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 01, 2019
Lead-free Chemical Indicators for Steam Sterilization
K181788
·
JOJ
General Hospital
·
239d
Cleared
Dec 09, 1980
BIOLOGICAL INDICATOR - KEMMED & BIOSURE
K802228
·
FRC
General Hospital
·
90d
Cleared
Dec 09, 1980
CHEMICAL INDICATOR - KEM MED & BIO SURE
K802229
·
JOJ
General Hospital
·
90d
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3
General Hospital
3