510k
Database
Specialties
Anesthesiology
141
Cardiovascular
579
Chemistry
167
Dental
324
Ear, Nose, Throat
68
Gastroenterology & Urology
296
General & Plastic Surgery
536
General Hospital
384
Hematology
67
Immunology
58
Medical Genetics
0
Microbiology
234
Neurology
173
Obstetrics & Gynecology
67
Ophthalmic
52
Orthopedic
1303
Pathology
18
Physical Medicine
88
Radiology
888
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
152
HRS
Plate, Fixation, Bone
136
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
87
MBI
Fastener, Fixation,...
85
MAX
Intervertebral Fusion Device...
84
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
83
JAK
System, X-ray, Tomography, Computed
79
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Coala Life AB
Medical Device Manufacturer
·
SE , Stockholm
Coala Life AB - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2019
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Coala Life AB
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 14, 2022
Coala Heart Monitor
K212163
·
DPS
Cardiovascular
·
276d
Cleared
Feb 08, 2019
Coala Heart Monitor
K182040
·
DXH
Cardiovascular
·
193d
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Cardiovascular
2