510k
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919
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2978
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1004
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2062
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371
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1780
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3322
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3118
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239
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226
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15
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949
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1459
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708
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467
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4609
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75
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654
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4110
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320
Categories
LLZ
System, Image Processing,...
700
GEX
Powered Laser Surgical Instrument
510
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System, Imaging, Pulsed Doppler,...
501
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Polymer Patient Examination Glove
483
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Electrosurgical, Cutting &...
475
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Plate, Fixation, Bone
412
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Intervertebral Fusion Device...
403
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Mask, Surgical
391
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System, Nuclear Magnetic...
345
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Thoracolumbosacral Pedicle Screw...
343
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Manufacturers
US
Cardiocom, LLC
Medical Device Manufacturer
·
US , Deer Field , IL
Cardiocom, LLC - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2005
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Cardiocom, LLC
Cardiovascular
✕
4
devices
1-4 of 4
Filters
Cleared
Aug 14, 2012
TABLET COMMANDER
K122285
·
DRG
Cardiovascular
·
15d
Cleared
Aug 25, 2009
COMMANDER 111, MODEL CD300-CD399
K091821
·
DXN
Cardiovascular
·
68d
Cleared
Dec 30, 2005
CARDIOCOM COMMANDER III
K053303
·
DXN
Cardiovascular
·
32d
Cleared
Dec 30, 2005
COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM
K053304
·
DXN
Cardiovascular
·
32d
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Cardiovascular
4