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3566
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1203
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2169
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383
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2046
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3500
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3369
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292
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259
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1072
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693
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4145
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LLZ
System, Image Processing,...
701
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589
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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
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Manufacturers
IL
Silmet , Ltd.
Medical Device Manufacturer
·
IL , Or Yehuda
Silmet , Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2010
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Silmet , Ltd.
Dental
✕
3
devices
1-3 of 3
Filters
Cleared
Sep 08, 2011
PROLINK ADHESIVES (PROLINK, PROLINK SE)
K110403
·
KLE
Dental
·
209d
Cleared
Feb 02, 2011
PROFIL COMPOSITES (PROFIL, PROFIL FLOW)
K103190
·
EBF
Dental
·
97d
Cleared
Sep 29, 2010
PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER)
K101869
·
EMA
Dental
·
89d
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3
Dental
3