510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1683
Chemistry
370
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1341
Ear, Nose, Throat
250
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979
General & Plastic Surgery
2201
General Hospital
2052
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126
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99
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8
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472
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969
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436
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279
Orthopedic
2961
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52
Physical Medicine
515
Radiology
2457
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
391
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
281
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
231
MAX
Intervertebral Fusion Device...
221
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Visus Health IT GmbH
Medical Device Manufacturer
·
DE , Bochum
Visus Health IT GmbH - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2018
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Visus Health IT GmbH
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Jul 14, 2023
JiveX (Model Number / Release: 5.4)
K231041
·
LLZ
Radiology
·
93d
Cleared
Sep 23, 2021
JiveX (Model Number / Release: 5.3)
K212321
·
LLZ
Radiology
·
59d
Cleared
Apr 14, 2020
JiveX
K200703
·
LLZ
Radiology
·
27d
Cleared
Oct 23, 2018
JiveX
K181964
·
LLZ
Radiology
·
92d
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4
Radiology
4