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3958
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2897
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516
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2657
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4415
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985
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1052
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15
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2049
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1930
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946
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8263
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978
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768
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696
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631
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601
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Powered Laser Surgical Instrument
527
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522
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Polymer Patient Examination Glove
489
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System, Nuclear Magnetic...
485
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Intervertebral Fusion Device...
444
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Thoracolumbosacral Pedicle Screw...
438
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510k Database
Manufacturers
US
Parexel Intl. Corp.
Medical Device Manufacturer
·
US , Mchenry , IL
Parexel Intl. Corp. - FDA 510(k) Cleared Devices
14 submissions
·
14 cleared
·
Since 1984
14
Total
14
Cleared
0
Denied
FDA 510(k) Regulatory Record - Parexel Intl. Corp.
Dental
✕
2
devices
1-2 of 2
Filters
Cleared
Jul 31, 1984
NATURA-TONE OR LUXOPAL CL ACRYLIC
K842208
·
ELM
Dental
·
57d
Cleared
Jul 12, 1984
NATURA-DENT VACUUM-FIRED PORCELAIN TEETH
K841826
·
ELL
Dental
·
71d
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14
Radiology
6
Cardiovascular
4
Dental
2
General & Plastic Surgery
1
General Hospital
1