510k
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Anesthesiology
204
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735
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187
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465
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91
Gastroenterology & Urology
391
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768
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473
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77
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63
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1
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275
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296
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115
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77
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1475
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26
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152
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1083
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93
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IYN
System, Imaging, Pulsed Doppler,...
167
HRS
Plate, Fixation, Bone
151
OLO
Orthopedic Stereotaxic Instrument
130
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Powered Laser Surgical Instrument
125
LLZ
System, Image Processing,...
123
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Automated Radiological Image...
109
NHA
Abutment, Implant, Dental,...
105
GEI
Electrosurgical, Cutting &...
105
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Curetis GmbH
Medical Device Manufacturer
·
DE , Holzgerlingen
Curetis GmbH - FDA 510(k) Cleared Devices
2 submissions
·
1 cleared
·
Since 2018
2
Total
1
Cleared
1
Denied
FDA 510(k) cleared devices by Curetis GmbH
Microbiology
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 20, 2019
Unyvero LRT BAL Application
K191967
·
QBH
Microbiology
·
150d
Not Cleared
Apr 03, 2018
Curetis Unyvero LRT Application
DEN170047
·
QBH
Microbiology
·
204d
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2
Microbiology
2