510k
Database
Specialties
Anesthesiology
134
Cardiovascular
569
Chemistry
165
Dental
316
Ear, Nose, Throat
68
Gastroenterology & Urology
289
General & Plastic Surgery
522
General Hospital
373
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
233
Neurology
168
Obstetrics & Gynecology
61
Ophthalmic
49
Orthopedic
1295
Pathology
18
Physical Medicine
86
Radiology
870
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
86
MBI
Fastener, Fixation,...
85
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Filmecc Co., Ltd.
Medical Device Manufacturer
·
JP , Hagoya-Shi
Filmecc Co., Ltd. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2021
5
Total
5
Cleared
0
Denied
FDA 510(k) cleared devices by Filmecc Co., Ltd.
Cardiovascular
✕
5
devices
1-5 of 5
Filters
Cleared
Mar 09, 2023
Vassallo GT 018 Hybrid
K223432
·
DQX
Cardiovascular
·
115d
Cleared
Oct 26, 2022
VASSALLO GT EXT
K222631
·
DQX
Cardiovascular
·
56d
Cleared
Jun 30, 2022
VASSALLO GT 018 Floppy
K213949
·
DQX
Cardiovascular
·
195d
Cleared
May 04, 2021
VASSALLO GT Hybrid
K203529
·
DQX
Cardiovascular
·
153d
Cleared
Apr 21, 2021
VASSALLO GT
K203533
·
DQX
Cardiovascular
·
140d
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5
Cardiovascular
5