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3562
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1203
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2158
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383
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2040
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3495
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3367
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292
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15
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1072
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1608
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470
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693
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4145
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LLZ
System, Image Processing,...
701
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580
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516
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Electrosurgical, Cutting &...
506
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System, Imaging, Pulsed Doppler,...
502
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Polymer Patient Examination Glove
483
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Intervertebral Fusion Device...
403
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Mask, Surgical
391
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Thoracolumbosacral Pedicle Screw...
347
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System, Nuclear Magnetic...
345
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Manufacturers
US
Commwell , Ltd.
Medical Device Manufacturer
·
US , Washington , DC
Commwell , Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2006
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Commwell , Ltd.
Cardiovascular
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 21, 2011
PHYSIOGLOVE ES WITH ECG ANALYSIS
K103791
·
DPS
Cardiovascular
·
298d
Cleared
Mar 10, 2009
PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1
K083677
·
DRX
Cardiovascular
·
89d
Cleared
Apr 25, 2006
PHYSIOGLOVE ES
K050674
·
DPS
Cardiovascular
·
406d
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Cardiovascular
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