510k
Database
Specialties
Anesthesiology
465
Cardiovascular
1405
Chemistry
334
Dental
1098
Ear, Nose, Throat
202
Gastroenterology & Urology
827
General & Plastic Surgery
1843
General Hospital
1317
Hematology
124
Immunology
86
Medical Genetics
7
Microbiology
420
Neurology
787
Obstetrics & Gynecology
351
Ophthalmic
223
Orthopedic
2450
Pathology
47
Physical Medicine
421
Radiology
2024
Toxicology
144
Categories
GEX
Powered Laser Surgical Instrument
300
LLZ
System, Image Processing,...
297
GEI
Electrosurgical, Cutting &...
257
QIH
Automated Radiological Image...
254
IYN
System, Imaging, Pulsed Doppler,...
244
HRS
Plate, Fixation, Bone
242
LZA
Polymer Patient Examination Glove
231
OLO
Orthopedic Stereotaxic Instrument
200
NHA
Abutment, Implant, Dental,...
190
MAX
Intervertebral Fusion Device...
171
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Biodan Medical Systems, Ltd.
Medical Device Manufacturer
·
IL , Israel
Biodan Medical Systems, Ltd. - FDA 510(k) Cleared Devices
20 submissions
·
20 cleared
·
Since 1982
20
Total
20
Cleared
0
Denied
FDA 510(k) Regulatory Record - Biodan Medical Systems, Ltd.
Chemistry
✕
1
devices
1-1 of 1
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Cleared
May 07, 1984
BIODEX ACT-O-KIT TSH-RIA-
K840088
·
JLW
Chemistry
·
118d
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20
Physical Medicine
9
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7
Microbiology
1
Gastroenterology & Urology
1
Immunology
1
Chemistry
1