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2200
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1214
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1183
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1085
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1066
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Polymer Patient Examination Glove
1011
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957
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953
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510k Database
Manufacturers
US
SurGenTec, LLC
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Medical Device Manufacturer
·
US , Boca Raton , FL
SurGenTec, LLC - FDA 510(k) Cleared Devices
28 submissions
·
28 cleared
·
Since 2017
Official Website
28
Total
28
Cleared
0
Denied
28
devices
26-28 of 28
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1
2
Cleared
Jul 16, 2019
ALARA Neuro Access Kit
K190163
·
PDQ
Neurology
·
166d
Cleared
May 10, 2018
Graftgun Universal Graft Delivery System
K180937
·
FMF
General Hospital
·
30d
Cleared
Jul 19, 2017
Graftgun Universal Graft Delivery System
K170675
·
FMF
General Hospital
·
135d
1
2
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28
Orthopedic
23
General Hospital
2
General & Plastic Surgery
2
Neurology
1