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4488
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3248
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530
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2829
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4563
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4177
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1085
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1351
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2417
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1995
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999
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546
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8334
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353
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996
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788
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698
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632
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621
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528
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522
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Polymer Patient Examination Glove
490
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485
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Intervertebral Fusion Device...
451
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Thoracolumbosacral Pedicle Screw...
443
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510k Database
Manufacturers
US
Colmed, Ltd.
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