510k
Database
Specialties
Anesthesiology
132
Cardiovascular
566
Chemistry
162
Dental
310
Ear, Nose, Throat
68
Gastroenterology & Urology
287
General & Plastic Surgery
513
General Hospital
370
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
232
Neurology
163
Obstetrics & Gynecology
61
Ophthalmic
49
Orthopedic
1288
Pathology
18
Physical Medicine
85
Radiology
866
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
133
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
99
MBI
Fastener, Fixation,...
84
MAX
Intervertebral Fusion Device...
83
NHA
Abutment, Implant, Dental,...
83
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Amra Medical AB
Medical Device Manufacturer
·
SE , Linkoping
Amra Medical AB - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2018
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Amra Medical AB
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Nov 24, 2021
AMRA Profiler
K211983
·
LNH
Radiology
·
152d
Cleared
Dec 06, 2018
AMRA Profiler
K173749
·
LNH
Radiology
·
363d
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2
Radiology
2