510k
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Anesthesiology
557
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1741
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387
Dental
1410
Ear, Nose, Throat
258
Gastroenterology & Urology
1009
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2259
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2112
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127
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105
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8
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478
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998
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461
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289
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3110
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52
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519
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2531
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156
Categories
LZA
Polymer Patient Examination Glove
424
LLZ
System, Image Processing,...
407
GEX
Powered Laser Surgical Instrument
371
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361
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Electrosurgical, Cutting &...
318
IYN
System, Imaging, Pulsed Doppler,...
307
HRS
Plate, Fixation, Bone
301
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
241
MAX
Intervertebral Fusion Device...
237
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Manufacturers
US
Medi-Tech, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Medi-Tech, Inc. - FDA 510(k) Cleared Devices
36 submissions
·
35 cleared
·
Since 1978
36
Total
35
Cleared
0
Denied
FDA 510(k) Regulatory Record - Medi-Tech, Inc.
Microbiology
✕
2
devices
1-2 of 2
Filters
Cleared
Feb 03, 1989
PF TEST
K884513
·
GMZ
Microbiology
·
99d
Cleared
Sep 30, 1988
ON THE SPOT CANDIDASURE
K883118
·
LRF
Microbiology
·
67d
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36
Cardiovascular
13
Gastroenterology & Urology
9
General & Plastic Surgery
4
Toxicology
4
Microbiology
2
Anesthesiology
1
Hematology
1
Dental
1
Chemistry
1