510k
Database
Specialties
Anesthesiology
541
Cardiovascular
1680
Chemistry
364
Dental
1337
Ear, Nose, Throat
245
Gastroenterology & Urology
971
General & Plastic Surgery
2191
General Hospital
2046
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
469
Neurology
965
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2922
Pathology
52
Physical Medicine
515
Radiology
2436
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
386
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
303
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
275
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Hi-Dow International, Inc.
Medical Device Manufacturer
·
US , St Louis , MO
Hi-Dow International, Inc. - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 2011
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hi-Dow International, Inc.
Physical Medicine
✕
2
devices
1-2 of 2
Filters
Cleared
Nov 12, 2021
Wrap Accessory Electrodes
K210383
·
GXY
Physical Medicine
·
276d
Cleared
Dec 15, 2020
Pulsed electromagnetic field wrap
K202337
·
ILX
Physical Medicine
·
120d
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6
Neurology
4
Physical Medicine
2