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3235
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2789
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725
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689
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568
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533
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Powered Laser Surgical Instrument
519
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Polymer Patient Examination Glove
489
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464
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Intervertebral Fusion Device...
403
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400
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Screw, Fixation, Bone
392
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Manufacturers
US
Hoffmann-La Roche, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Hoffmann-La Roche, Inc. - FDA 510(k) Cleared Devices
49 submissions
·
49 cleared
·
Since 1976
Official Website
49
Total
49
Cleared
0
Denied
27
devices
26-27 of 27
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1
2
Cleared
Mar 21, 1979
SENSI-TEX
K790267
·
JHJ
Chemistry
·
43d
Cleared
Mar 30, 1978
ROCHE TSH RIA
K780428
·
JLW
Chemistry
·
13d
1
2
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49
Chemistry
27
Toxicology
14
Microbiology
5
Immunology
3