510k
Database
Specialties
Anesthesiology
507
Cardiovascular
1577
Chemistry
355
Dental
1263
Ear, Nose, Throat
233
Gastroenterology & Urology
911
General & Plastic Surgery
2096
General Hospital
1788
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
445
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918
Obstetrics & Gynecology
417
Ophthalmic
265
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2673
Pathology
49
Physical Medicine
502
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2281
Toxicology
154
Categories
LZA
Polymer Patient Examination Glove
360
LLZ
System, Image Processing,...
350
GEX
Powered Laser Surgical Instrument
347
GEI
Electrosurgical, Cutting &...
290
QIH
Automated Radiological Image...
272
IYN
System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
260
FXX
Mask, Surgical
239
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
204
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Meditera Tibbi Malzeme San VE Tic AS
Medical Device Manufacturer
·
TR , Izmir
Meditera Tibbi Malzeme San VE Tic AS - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2020
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Meditera Tibbi Malzeme San VE Tic AS
Anesthesiology
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 23, 2021
Altech® Exhalation Valve (Single Limb and Dual Limb)
K210992
·
CBP
Anesthesiology
·
265d
Cleared
Jan 17, 2020
Altera gas Sampling Lines
K192563
·
CCK
Anesthesiology
·
122d
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3
Anesthesiology
2
General Hospital
1