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9831
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2381
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2005
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1879
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1293
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1264
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1115
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1110
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Polymer Patient Examination Glove
1052
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988
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Screw, Fixation, Bone
976
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510k Database
Manufacturers
US
Colmed, Ltd.
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Medical Device Manufacturer
·
US , Mchenry , IL
Colmed, Ltd. - FDA 510(k) Cleared Devices
7 submissions
·
7 cleared
·
Since 1979
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Colmed, Ltd.
Dental
✕
4
devices
1-4 of 4
Filters
Cleared
Jun 16, 1981
JACOB WIRZ TRANSFIXATION PIN
K811209
·
ELS
Dental
·
46d
Cleared
Feb 10, 1981
HALOGEN HEADLIGHT SYSTEM
K810117
·
EBA
Dental
·
25d
Cleared
May 28, 1980
HOLLOW BASKET TITANIUM DENTAL IMPLANT
K801208
·
ELE
Dental
·
8d
Cleared
May 14, 1980
PS3 TITANIUM SCREW DENTAL IMPLANT
K800762
·
DZE
Dental
·
37d
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7
Dental
4
Orthopedic
1
Physical Medicine
1
General & Plastic Surgery
1