510k
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471
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1414
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334
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1117
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208
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833
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1869
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1369
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124
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87
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8
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423
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805
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354
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232
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2464
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48
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429
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2038
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144
Categories
GEX
Powered Laser Surgical Instrument
303
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System, Image Processing,...
300
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Electrosurgical, Cutting &...
258
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Automated Radiological Image...
255
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Polymer Patient Examination Glove
250
IYN
System, Imaging, Pulsed Doppler,...
245
HRS
Plate, Fixation, Bone
243
OLO
Orthopedic Stereotaxic Instrument
202
NHA
Abutment, Implant, Dental,...
190
MAX
Intervertebral Fusion Device...
171
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Comet North America, Inc.
Medical Device Manufacturer
·
US , Norwalk , CT
Comet North America, Inc. - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 1991
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Comet North America, Inc.
Radiology
✕
1
devices
1-1 of 1
Filters
Cleared
Aug 28, 1991
MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM
K913301
·
ITY
Radiology
·
34d
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1
Radiology
1