510k
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1290
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3348
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2802
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474
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2457
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4191
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3868
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808
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796
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15
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1914
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891
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497
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8058
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167
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964
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System, Image Processing,...
743
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696
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570
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System, Imaging, Pulsed Doppler,...
544
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Powered Laser Surgical Instrument
523
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Prosthesis, Knee,...
517
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Polymer Patient Examination Glove
489
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System, Nuclear Magnetic...
473
MAX
Intervertebral Fusion Device...
435
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Screw, Fixation, Bone
402
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Manufacturers
US
Bosworth Co.
Medical Device Manufacturer
·
US , Walker , MI
Bosworth Co. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1981
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bosworth Co.
Dental
✕
4
devices
1-4 of 4
Filters
Cleared
Oct 07, 1999
MODIFICATION TO LINER II: SOFT RELINE LIQUID
K991687
·
EBI
Dental
·
143d
Cleared
Jul 26, 1999
LC PIT & FISSURE SEALANT
K991902
·
EBC
Dental
·
52d
Cleared
Aug 28, 1995
BOSWORTH RESIN II
K953119
·
EBI
Dental
·
56d
Cleared
Feb 02, 1981
DENTURE RUBBER BASE MATERIAL
K810094
·
EBI
Dental
·
19d
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4
Dental
4