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1355
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5035
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3958
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2897
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515
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2657
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4403
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4000
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984
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936
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15
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1966
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1930
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946
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527
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8263
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189
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978
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5352
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1325
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System, Image Processing,...
768
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696
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System, Imaging, Pulsed Doppler,...
631
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Electrosurgical, Cutting &...
597
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Powered Laser Surgical Instrument
527
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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
Endo Technic Corp.
Medical Device Manufacturer
·
US , Natick , MA
Endo Technic Corp. - FDA 510(k) Cleared Devices
10 submissions
·
10 cleared
·
Since 1986
10
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Endo Technic Corp.
Dental
✕
3
devices
1-3 of 3
Filters
Cleared
May 27, 1999
MILLENNIUM
K990908
·
MXF
Dental
·
70d
Cleared
Feb 27, 1987
SOLUSET CALCIUM DEMINERALIZING SOLUTION
K864976
·
EKS
Dental
·
70d
Cleared
Jul 22, 1986
SET CANAL SEALER PASTE
K862129
·
EKM
Dental
·
48d
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10
Dental
3
Obstetrics & Gynecology
3
General & Plastic Surgery
3
Radiology
1