510k
Database
Specialties
Anesthesiology
542
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1683
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370
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1341
Ear, Nose, Throat
250
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978
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2199
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2050
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126
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99
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8
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471
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966
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436
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279
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2949
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52
Physical Medicine
515
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2454
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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
280
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Naviswiss AG
Medical Device Manufacturer
·
CH , Brugg
Naviswiss AG - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2020
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Naviswiss AG
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Jan 31, 2023
Naviswiss Knee
K223351
·
OLO
Orthopedic
·
90d
Cleared
Jun 10, 2020
Naviswiss Hip Navigation System
K193094
·
OLO
Orthopedic
·
216d
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3
Orthopedic
2
Radiology
1