510k
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Anesthesiology
1330
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4923
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3614
Dental
2818
Ear, Nose, Throat
475
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2514
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4256
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3897
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889
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836
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15
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1931
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1842
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893
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498
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8201
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187
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978
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5179
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1299
Categories
LLZ
System, Image Processing,...
757
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Plate, Fixation, Bone
696
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System, Imaging, Pulsed Doppler,...
609
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Electrosurgical, Cutting &...
571
GEX
Powered Laser Surgical Instrument
523
JWH
Prosthesis, Knee,...
522
LZA
Polymer Patient Examination Glove
489
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System, Nuclear Magnetic...
475
MAX
Intervertebral Fusion Device...
444
NKB
Thoracolumbosacral Pedicle Screw...
437
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Manufacturers
US
Etex Corp.
Medical Device Manufacturer
·
US , Cambridge , MA
Etex Corp. - FDA 510(k) Cleared Devices
18 submissions
·
17 cleared
·
Since 1994
18
Total
17
Cleared
0
Denied
FDA 510(k) Regulatory Record - Etex Corp.
Dental
✕
3
devices
1-3 of 3
Filters
Cleared
Dec 21, 2010
CARRIGEN
K100883
·
LYC
Dental
·
266d
Cleared
Dec 23, 2009
ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE
K091729
·
LYC
Dental
·
195d
Cleared
Aug 05, 1997
BSM BONE SUBSTITUTE MATERIAL KIT
K962548
·
LYC
Dental
·
403d
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18
Orthopedic
13
Dental
3
Neurology
2