510k
Database
Specialties
Anesthesiology
493
Cardiovascular
1518
Chemistry
345
Dental
1196
Ear, Nose, Throat
222
Gastroenterology & Urology
874
General & Plastic Surgery
1985
General Hospital
1539
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
437
Neurology
869
Obstetrics & Gynecology
383
Ophthalmic
254
Orthopedic
2600
Pathology
49
Physical Medicine
464
Radiology
2171
Toxicology
153
Categories
GEX
Powered Laser Surgical Instrument
324
LLZ
System, Image Processing,...
322
LZA
Polymer Patient Examination Glove
297
GEI
Electrosurgical, Cutting &...
276
QIH
Automated Radiological Image...
263
IYN
System, Imaging, Pulsed Doppler,...
260
HRS
Plate, Fixation, Bone
251
OLO
Orthopedic Stereotaxic Instrument
215
NHA
Abutment, Implant, Dental,...
201
MAX
Intervertebral Fusion Device...
185
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Isotechnologies, Inc.
Medical Device Manufacturer
·
US , Walker , MI
Isotechnologies, Inc. - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 1984
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Isotechnologies, Inc.
Neurology
✕
1
devices
1-1 of 1
Filters
Cleared
Jan 27, 1994
ISOTECHNOLOGIES BACK TRACKER AND BACK WORKS SOFTWA
K933063
·
KQX
Neurology
·
219d
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6
Physical Medicine
4
Orthopedic
1
Neurology
1