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1378
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5265
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3959
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2897
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516
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2666
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4420
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4006
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985
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1052
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15
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2099
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1930
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974
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541
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8267
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201
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978
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5369
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1325
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System, Image Processing,...
770
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Plate, Fixation, Bone
696
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System, Imaging, Pulsed Doppler,...
632
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Electrosurgical, Cutting &...
601
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Powered Laser Surgical Instrument
528
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Prosthesis, Knee,...
522
LZA
Polymer Patient Examination Glove
489
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System, Nuclear Magnetic...
485
MAX
Intervertebral Fusion Device...
444
NKB
Thoracolumbosacral Pedicle Screw...
438
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510k Database
Manufacturers
US
Syntex Corp.
Medical Device Manufacturer
·
US , Mchenry , IL
Syntex Corp. - FDA 510(k) Cleared Devices
10 submissions
·
10 cleared
·
Since 1976
10
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Syntex Corp.
Dental
✕
4
devices
1-4 of 4
Filters
Cleared
Jul 27, 1978
AMALGAM ALLOY
K780997
·
EJJ
Dental
·
43d
Cleared
Apr 28, 1978
FIBER OPTIC HANDPIECE
K780483
·
EFB
Dental
·
32d
Cleared
Jan 03, 1977
OPUS I OPTION - FIBER OPTIC L SYSTEM
K761331
·
EAY
Dental
·
7d
Cleared
Dec 23, 1976
OPTIONS FOR STAR DENTAL OPUS I
K761264
·
DYN
Dental
·
7d
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10
Radiology
4
Dental
4
Toxicology
1
General & Plastic Surgery
1