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2897
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499
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1965
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978
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696
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592
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527
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522
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Polymer Patient Examination Glove
489
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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
Carl Zeiss, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Carl Zeiss, Inc. - FDA 510(k) Cleared Devices
44 submissions
·
44 cleared
·
Since 1980
44
Total
44
Cleared
0
Denied
FDA 510(k) Regulatory Record - Carl Zeiss, Inc.
Neurology
✕
1
devices
1-1 of 1
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Cleared
Apr 23, 1997
SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM
K965139
·
HAW
Neurology
·
121d
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44
General & Plastic Surgery
26
Ophthalmic
13
General Hospital
1
Gastroenterology & Urology
1
Radiology
1
Obstetrics & Gynecology
1
Neurology
1