510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1660
Chemistry
362
Dental
1333
Ear, Nose, Throat
244
Gastroenterology & Urology
958
General & Plastic Surgery
2183
General Hospital
2039
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
466
Neurology
962
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2868
Pathology
52
Physical Medicine
515
Radiology
2428
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
383
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
219
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Ellex Medical Pty, Ltd.
Medical Device Manufacturer
·
AU , Adelaide, South Australia
Ellex Medical Pty, Ltd. - FDA 510(k) Cleared Devices
13 submissions
·
13 cleared
·
Since 1997
13
Total
13
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ellex Medical Pty, Ltd.
Radiology
✕
1
devices
1-1 of 1
Filters
Cleared
Apr 11, 2019
Eye Prime
K190786
·
IYO
Radiology
·
15d
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13
Ophthalmic
8
General & Plastic Surgery
4
Radiology
1