510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1680
Chemistry
365
Dental
1338
Ear, Nose, Throat
249
Gastroenterology & Urology
975
General & Plastic Surgery
2196
General Hospital
2048
Hematology
126
Immunology
99
Medical Genetics
8
Microbiology
469
Neurology
965
Obstetrics & Gynecology
434
Ophthalmic
279
Orthopedic
2940
Pathology
52
Physical Medicine
515
Radiology
2444
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
388
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
306
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
278
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Fiagon GmbH
Medical Device Manufacturer
·
DE , Hennigsdorf
Fiagon GmbH - FDA 510(k) Cleared Devices
15 submissions
·
15 cleared
·
Since 2014
15
Total
15
Cleared
0
Denied
FDA 510(k) Regulatory Record - Fiagon GmbH
Neurology
✕
2
devices
1-2 of 2
Filters
Cleared
Sep 14, 2017
Fiagon Navigation System
K163209
·
HAW
Neurology
·
303d
Cleared
Apr 01, 2016
Fiagon Navigation System
K151156
·
HAW
Neurology
·
336d
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15
Ear, Nose, Throat
12
Neurology
2
Orthopedic
1