510k
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Anesthesiology
1480
Cardiovascular
5359
Chemistry
4313
Dental
3248
Ear, Nose, Throat
530
Gastroenterology & Urology
2829
General & Plastic Surgery
4562
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4176
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1074
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1228
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15
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2406
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1995
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995
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546
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8334
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347
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996
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5410
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1340
Categories
LLZ
System, Image Processing,...
780
HRS
Plate, Fixation, Bone
698
IYN
System, Imaging, Pulsed Doppler,...
632
GEI
Electrosurgical, Cutting &...
621
GEX
Powered Laser Surgical Instrument
528
JWH
Prosthesis, Knee,...
522
LZA
Polymer Patient Examination Glove
490
LNH
System, Nuclear Magnetic...
485
MAX
Intervertebral Fusion Device...
451
NKB
Thoracolumbosacral Pedicle Screw...
443
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510k Database
Manufacturers
US
Etex Co.
Medical Device Manufacturer
·
US , Cambridge , MA
Etex Co. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 1992
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Etex Co.
Dental
✕
1
devices
1-1 of 1
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Cleared
Feb 19, 1992
ETEX DENTAL IMPLANT SYSTEM
K913417
·
DZE
Dental
·
203d
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2
Dental
1
Orthopedic
1