510k
Database
Specialties
Anesthesiology
135
Cardiovascular
570
Chemistry
165
Dental
318
Ear, Nose, Throat
68
Gastroenterology & Urology
290
General & Plastic Surgery
526
General Hospital
377
Hematology
67
Immunology
57
Medical Genetics
0
Microbiology
234
Neurology
173
Obstetrics & Gynecology
62
Ophthalmic
51
Orthopedic
1296
Pathology
18
Physical Medicine
87
Radiology
875
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
151
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...
83
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Unomedical A/S
Medical Device Manufacturer
·
DK , Roskilde
Unomedical A/S - FDA 510(k) Cleared Devices
13 submissions
·
13 cleared
·
Since 2003
13
Total
13
Cleared
0
Denied
FDA 510(k) cleared devices by Unomedical A/S
Chemistry
✕
1
devices
1-1 of 1
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Cleared
Jul 16, 2021
Medtronic Extended infusion set
K210544
·
FPA
Chemistry
·
142d
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13
General Hospital
12
Chemistry
1