510k
Database
Specialties
Anesthesiology
117
Cardiovascular
507
Chemistry
156
Dental
276
Ear, Nose, Throat
59
Gastroenterology & Urology
258
General & Plastic Surgery
439
General Hospital
339
Hematology
63
Immunology
55
Medical Genetics
0
Microbiology
221
Neurology
133
Obstetrics & Gynecology
43
Ophthalmic
41
Orthopedic
1214
Pathology
18
Physical Medicine
58
Radiology
789
Toxicology
86
Categories
IYN
System, Imaging, Pulsed Doppler,...
145
HRS
Plate, Fixation, Bone
123
OLO
Orthopedic Stereotaxic Instrument
108
LLZ
System, Image Processing,...
93
MAX
Intervertebral Fusion Device...
80
NHA
Abutment, Implant, Dental,...
80
NKB
Thoracolumbosacral Pedicle Screw...
77
MBI
Fastener, Fixation,...
77
LNH
System, Nuclear Magnetic...
76
JAK
System, X-ray, Tomography, Computed
73
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Datex-Ohmeda
Medical Device Manufacturer
·
US , Tewksbury , MA
Datex-Ohmeda - FDA 510(k) Cleared Devices
41 submissions
·
41 cleared
·
Since 2000
41
Total
41
Cleared
0
Denied
FDA 510(k) cleared devices by Datex-Ohmeda
Neurology
✕
2
devices
1-2 of 2
Filters
Cleared
Jan 13, 2003
DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES
K023459
·
OLW
Neurology
·
90d
Cleared
Jan 10, 2002
DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES
K013389
·
OLW
Neurology
·
90d
Filters
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41
Cardiovascular
23
Anesthesiology
11
General Hospital
4
Neurology
2
Obstetrics & Gynecology
1