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3577
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1582
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2196
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437
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2139
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3595
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353
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15
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1148
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1617
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81
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694
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4150
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704
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System, Image Processing,...
705
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610
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520
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Powered Laser Surgical Instrument
519
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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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Prosthesis, Knee,...
350
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Thoracolumbosacral Pedicle Screw...
347
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Manufacturers
US
Thermotek, Inc.
Medical Device Manufacturer
·
US , Carrollton , TX
Thermotek, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
3 cleared
·
Since 1995
4
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Thermotek, Inc.
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 10, 2010
VASCUCOMP
K103247
·
JOW
Cardiovascular
·
37d
Cleared
Aug 22, 2006
NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPS
K061866
·
JOW
Cardiovascular
·
50d
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Physical Medicine
2
Cardiovascular
2