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147
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1295
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740
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97
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72
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363
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554
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240
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151
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2001
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307
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1553
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227
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207
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205
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203
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System, Image Processing,...
191
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Electrosurgical, Cutting &...
182
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Orthopedic Stereotaxic Instrument
166
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Abutment, Implant, Dental,...
151
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Intervertebral Fusion Device...
136
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Thoracolumbosacral Pedicle Screw...
132
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Wallac OY
Medical Device Manufacturer
·
FI , Finland
Wallac OY - FDA 510(k) Cleared Devices
22 submissions
·
21 cleared
·
Since 1992
22
Total
21
Cleared
1
Denied
FDA 510(k) Regulatory Record - Wallac OY
Pathology
✕
1
devices
1-1 of 1
Filters
Not Cleared
Dec 15, 2014
PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM
DEN140010
·
PJI
Pathology
·
299d
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22
Chemistry
18
Toxicology
2
Pathology
1
Hematology
1