510k
Database
Specialties
Anesthesiology
674
Cardiovascular
2075
Chemistry
458
Dental
1681
Ear, Nose, Throat
302
Gastroenterology & Urology
1181
General & Plastic Surgery
2596
General Hospital
2358
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142
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127
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12
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569
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1173
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532
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354
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3698
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57
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566
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2934
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166
Categories
LLZ
System, Image Processing,...
483
LZA
Polymer Patient Examination Glove
444
GEX
Powered Laser Surgical Instrument
426
FXX
Mask, Surgical
386
GEI
Electrosurgical, Cutting &...
376
IYN
System, Imaging, Pulsed Doppler,...
358
HRS
Plate, Fixation, Bone
344
MAX
Intervertebral Fusion Device...
294
QIH
Automated Radiological Image...
285
OLO
Orthopedic Stereotaxic Instrument
280
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Manufacturers
US
Polymer Technology Systems, Inc.
Medical Device Manufacturer
·
US , Indianapolis , IN
Polymer Technology Systems, Inc. - FDA 510(k) Cleared Devices
27 submissions
·
27 cleared
·
Since 1998
27
Total
27
Cleared
0
Denied
27
devices
26-27 of 27
Filters
1
2
Cleared
Jul 22, 1998
MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220
K981493
·
CHH
Chemistry
·
86d
Cleared
Jan 22, 1998
MTM BIOSCANNER 1000 TEST SYSTEM CONSISTING OF MTM BIOSCANNER 1000 METER, MTM...
K972669
·
CGA
Chemistry
·
190d
1
2
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27
Chemistry
27