510k
Database
Specialties
Anesthesiology
199
Cardiovascular
723
Chemistry
186
Dental
451
Ear, Nose, Throat
86
Gastroenterology & Urology
383
General & Plastic Surgery
751
General Hospital
462
Hematology
75
Immunology
61
Medical Genetics
1
Microbiology
273
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289
Obstetrics & Gynecology
112
Ophthalmic
75
Orthopedic
1465
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26
Physical Medicine
146
Radiology
1069
Toxicology
93
Categories
IYN
System, Imaging, Pulsed Doppler,...
162
HRS
Plate, Fixation, Bone
150
OLO
Orthopedic Stereotaxic Instrument
128
LLZ
System, Image Processing,...
122
GEX
Powered Laser Surgical Instrument
122
QIH
Automated Radiological Image...
107
GEI
Electrosurgical, Cutting &...
104
NHA
Abutment, Implant, Dental,...
103
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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About
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Euroimmun Us, Inc.
Medical Device Manufacturer
·
US , Morristown , NJ
Euroimmun Us, Inc. - FDA 510(k) Cleared Devices
19 submissions
·
19 cleared
·
Since 2009
19
Total
19
Cleared
0
Denied
FDA 510(k) cleared devices by Euroimmun Us, Inc.
Microbiology
✕
3
devices
1-3 of 3
Filters
Cleared
Dec 10, 2017
Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)
K172722
·
LSR
Microbiology
·
90d
Cleared
Aug 12, 2016
EUROIMMUN Anti-West Nile Virus ELISA (IgM)
K153308
·
NOP
Microbiology
·
269d
Cleared
Aug 10, 2016
EUROIMMUN Anti-West Nile Virus ELISA (IgG)
K153303
·
NOP
Microbiology
·
268d
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19
Immunology
16
Microbiology
3