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4923
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3460
Dental
2813
Ear, Nose, Throat
475
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2514
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4254
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3896
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853
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804
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15
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1921
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1841
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893
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498
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8086
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177
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978
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5179
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1263
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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 &...
570
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Powered Laser Surgical Instrument
523
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Prosthesis, Knee,...
522
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Polymer Patient Examination Glove
489
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System, Nuclear Magnetic...
475
MAX
Intervertebral Fusion Device...
436
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Screw, Fixation, Bone
404
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Manufacturers
US
Combe, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Combe, Inc. - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 1977
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Combe, Inc.
Dental
✕
4
devices
1-4 of 4
Filters
Cleared
Aug 10, 1994
OTC DENTURE CLEANSER
K942203
·
EFT
Dental
·
97d
Cleared
Jan 11, 1993
CFR MONOGRAPH
K925259
·
EFT
Dental
·
84d
Cleared
Sep 19, 1986
SEA-BOND
K863375
·
KXX
Dental
·
16d
Cleared
Jun 24, 1977
CUSHIONS, DENTURE ADHESIVE, ALL-DAY
K770413
·
EHS
Dental
·
112d
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6
Dental
4
General Hospital
2