510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1666
Chemistry
362
Dental
1334
Ear, Nose, Throat
245
Gastroenterology & Urology
963
General & Plastic Surgery
2186
General Hospital
2043
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
466
Neurology
965
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2886
Pathology
52
Physical Medicine
515
Radiology
2431
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
384
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
353
GEI
Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
270
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
219
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Hivox Biotek, Inc.
Medical Device Manufacturer
·
TW , Taipei
Hivox Biotek, Inc. - FDA 510(k) Cleared Devices
17 submissions
·
17 cleared
·
Since 2002
17
Total
17
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hivox Biotek, Inc.
Physical Medicine
✕
3
devices
1-3 of 3
Filters
Cleared
Nov 08, 2019
HIVOX Spopad EMS SP-911, SP-921
K192264
·
NGX
Physical Medicine
·
79d
Cleared
Jul 27, 2015
EM25 - glute toning device
K143737
·
NGX
Physical Medicine
·
209d
Cleared
Jan 16, 2015
HIVOX SPOPAD EMS
K141921
·
NGX
Physical Medicine
·
184d
Filters
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17
Neurology
13
Physical Medicine
3
General Hospital
1