510k
Database
Specialties
Anesthesiology
545
Cardiovascular
1694
Chemistry
370
Dental
1351
Ear, Nose, Throat
250
Gastroenterology & Urology
979
General & Plastic Surgery
2213
General Hospital
2059
Hematology
126
Immunology
100
Medical Genetics
8
Microbiology
474
Neurology
980
Obstetrics & Gynecology
438
Ophthalmic
280
Orthopedic
2986
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52
Physical Medicine
515
Radiology
2466
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
413
LLZ
System, Image Processing,...
398
GEX
Powered Laser Surgical Instrument
363
FXX
Mask, Surgical
358
GEI
Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
284
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
224
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Asset Medikal Tasarim As.
Medical Device Manufacturer
·
TR , Istanbul
Asset Medikal Tasarim As. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2020
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Asset Medikal Tasarim As.
General Hospital
✕
4
devices
1-4 of 4
Filters
Cleared
Sep 26, 2022
Flowart
K221473
·
FPA
General Hospital
·
129d
Cleared
Sep 23, 2022
NeutrArt
K221481
·
FPA
General Hospital
·
123d
Cleared
Jan 05, 2021
NeutrArt
K201872
·
FPA
General Hospital
·
182d
Cleared
Feb 20, 2020
Flowart
K190806
·
FPA
General Hospital
·
328d
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4
General Hospital
4