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4950
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1512
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4405
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6969
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5665
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1726
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2228
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4189
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2608
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1526
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1252
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11062
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580
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1373
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7450
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1935
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1042
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1037
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959
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805
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797
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System, Imaging, Pulsed Doppler,...
751
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Prosthesis, Knee,...
720
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Laparoscope, General & Plastic...
646
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Thoracolumbosacral Pedicle Screw...
615
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Intervertebral Fusion Device...
577
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Manufacturers
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Search FDA 510(k) devices
510k Database
Manufacturers
US
Empi
Medical Device Manufacturer
·
US , Walker , MI
Empi - FDA 510(k) Cleared Devices
60 submissions
·
56 cleared
·
Since 1977
Official Website
60
Total
56
Cleared
0
Denied
29
devices
26-29 of 29
Filters
1
2
Cleared
May 14, 1980
EMPI MODEL 910S, TENS
K801112
·
GZJ
Neurology
·
2d
Cleared
Mar 17, 1980
FES ORTHOSIS MODEL NO. 2000
K800380
·
GZI
Neurology
·
24d
Cleared
Dec 13, 1979
MODEL 980D TENS NEUROPACER
K792522
·
GZJ
Neurology
·
7d
Cleared
Nov 02, 1977
IMPORTED PAIN CONTROL DEVICE
K771885
·
GZJ
Neurology
·
28d
1
2
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60
Neurology
29
Physical Medicine
20
Gastroenterology & Urology
10
General & Plastic Surgery
1