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725
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689
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558
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533
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519
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Polymer Patient Examination Glove
489
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461
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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
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Manufacturers
US
Erbe USA, Inc.
Medical Device Manufacturer
·
US , Lawrenceville , GA
Erbe USA, Inc. - FDA 510(k) Cleared Devices
39 submissions
·
39 cleared
·
Since 1994
39
Total
39
Cleared
0
Denied
27
devices
26-27 of 27
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1
2
Cleared
Mar 09, 1994
ERBOTOM ICC 350
K933002
·
GEI
General & Plastic Surgery
·
261d
Cleared
Feb 23, 1994
ERBOTOM ICC 200
K933157
·
GEI
General & Plastic Surgery
·
239d
1
2
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39
General & Plastic Surgery
27
Gastroenterology & Urology
9
General Hospital
3