510k
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Anesthesiology
1352
Cardiovascular
5022
Chemistry
3888
Dental
2896
Ear, Nose, Throat
492
Gastroenterology & Urology
2608
General & Plastic Surgery
4323
General Hospital
3995
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983
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936
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15
Microbiology
1963
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1925
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925
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507
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8249
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188
Physical Medicine
978
Radiology
5349
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1325
Categories
LLZ
System, Image Processing,...
768
HRS
Plate, Fixation, Bone
696
IYN
System, Imaging, Pulsed Doppler,...
631
GEI
Electrosurgical, Cutting &...
590
GEX
Powered Laser Surgical Instrument
527
JWH
Prosthesis, Knee,...
522
LZA
Polymer Patient Examination Glove
489
LNH
System, Nuclear Magnetic...
485
MAX
Intervertebral Fusion Device...
444
NKB
Thoracolumbosacral Pedicle Screw...
438
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510k Database
Manufacturers
US
Xomed, Inc.
Medical Device Manufacturer
·
US , Arnold , MO
Xomed, Inc. - FDA 510(k) Cleared Devices
82 submissions
·
81 cleared
·
Since 1976
82
Total
81
Cleared
0
Denied
FDA 510(k) Regulatory Record - Xomed, Inc.
Dental
✕
1
devices
1-1 of 1
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Cleared
Sep 21, 1976
ROBINSON MIDDLE EAR PROSTHESIS
K760570
·
EIB
Dental
·
20d
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82
Ear, Nose, Throat
51
General & Plastic Surgery
17
Orthopedic
3
General Hospital
3
Ophthalmic
2
Dental
1
Cardiovascular
1
Anesthesiology
1
Gastroenterology & Urology
1
Obstetrics & Gynecology
1