510k
Database
Specialties
Anesthesiology
138
Cardiovascular
573
Chemistry
165
Dental
321
Ear, Nose, Throat
68
Gastroenterology & Urology
292
General & Plastic Surgery
530
General Hospital
379
Hematology
67
Immunology
58
Medical Genetics
0
Microbiology
234
Neurology
173
Obstetrics & Gynecology
64
Ophthalmic
51
Orthopedic
1298
Pathology
18
Physical Medicine
88
Radiology
880
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
152
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
86
MBI
Fastener, Fixation,...
85
MAX
Intervertebral Fusion Device...
84
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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HORIBA ABX SAS
Medical Device Manufacturer
·
FR , Montpellier Cedex 4
HORIBA ABX SAS - FDA 510(k) Cleared Devices
17 submissions
·
17 cleared
·
Since 2009
17
Total
17
Cleared
0
Denied
FDA 510(k) cleared devices by HORIBA ABX SAS
Hematology
✕
4
devices
1-4 of 4
Filters
Cleared
May 21, 2024
Yumizen H2500
K232946
·
GKZ
Hematology
·
244d
Cleared
Nov 01, 2017
ABX MICROS ES 60 OT and ABX MICROS ES 60 CT
K170353
·
GKZ
Hematology
·
271d
Cleared
Dec 09, 2015
PENTRA XLR
K151133
·
GKZ
Hematology
·
225d
Cleared
Dec 20, 2014
ABX MICROS ES 60 CT
K141161
·
GKZ
Hematology
·
229d
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17
Chemistry
10
Hematology
4
Immunology
3