510k
Database
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Anesthesiology
1137
Cardiovascular
4618
Chemistry
3346
Dental
2794
Ear, Nose, Throat
469
Gastroenterology & Urology
2453
General & Plastic Surgery
4190
General Hospital
3857
Hematology
808
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796
Medical Genetics
15
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1914
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1773
Obstetrics & Gynecology
890
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497
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7871
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167
Physical Medicine
963
Radiology
4789
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1242
Categories
LLZ
System, Image Processing,...
730
HRS
Plate, Fixation, Bone
696
GEI
Electrosurgical, Cutting &...
570
IYN
System, Imaging, Pulsed Doppler,...
535
GEX
Powered Laser Surgical Instrument
523
JWH
Prosthesis, Knee,...
517
LZA
Polymer Patient Examination Glove
489
LNH
System, Nuclear Magnetic...
431
MAX
Intervertebral Fusion Device...
406
HWC
Screw, Fixation, Bone
401
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Manufacturers
US
Dacomed Corp.
Medical Device Manufacturer
·
US , Mchenry , IL
Dacomed Corp. - FDA 510(k) Cleared Devices
20 submissions
·
20 cleared
·
Since 1981
20
Total
20
Cleared
0
Denied
FDA 510(k) Regulatory Record - Dacomed Corp.
Ear, Nose, Throat
✕
1
devices
1-1 of 1
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Cleared
Mar 17, 1986
DACOMED CORP. ESKA-HERRMAN VOICE PROSTHESIS
K854118
·
EWL
Ear, Nose, Throat
·
159d
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20
Gastroenterology & Urology
18
Chemistry
1
Ear, Nose, Throat
1