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13337
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10830
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8747
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2644
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7100
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12222
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2514
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3047
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20
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5821
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4209
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2848
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2602
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15325
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832
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2537
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11127
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2531
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2068
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1657
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1571
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1146
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Implant, Endosseous, Root-form
1094
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System, Imaging, Pulsed Doppler,...
1026
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Laparoscope, General & Plastic...
1016
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Hearing Aid, Air-conduction,...
953
LZA
Polymer Patient Examination Glove
949
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System, Nuclear Magnetic...
936
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Manufacturers
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Search FDA 510(k) devices
510k Database
Manufacturers
US
Empi
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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