510k
Database
Specialties
Anesthesiology
133
Cardiovascular
568
Chemistry
163
Dental
313
Ear, Nose, Throat
68
Gastroenterology & Urology
287
General & Plastic Surgery
514
General Hospital
371
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
232
Neurology
164
Obstetrics & Gynecology
61
Ophthalmic
49
Orthopedic
1291
Pathology
18
Physical Medicine
85
Radiology
867
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
MBI
Fastener, Fixation,...
85
NHA
Abutment, Implant, Dental,...
84
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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Syntheticmr AB
Medical Device Manufacturer
·
SE , Linkoping
Syntheticmr AB - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 2017
6
Total
6
Cleared
0
Denied
FDA 510(k) cleared devices by Syntheticmr AB
Radiology
✕
6
devices
1-6 of 6
Filters
Cleared
Nov 03, 2021
SyMRI
K203372
·
LNH
Radiology
·
352d
Cleared
Jul 28, 2020
SyMRI
K201616
·
LNH
Radiology
·
43d
Cleared
Jun 13, 2019
SyMRI
K191036
·
LNH
Radiology
·
56d
Cleared
Jun 12, 2018
SyMRI
K181093
·
LNH
Radiology
·
48d
Cleared
Jan 26, 2018
SyMRI
K173558
·
LNH
Radiology
·
70d
Cleared
Aug 29, 2017
SyMRI
K162943
·
LNH
Radiology
·
312d
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6
Radiology
6