510k
Database
Specialties
Anesthesiology
545
Cardiovascular
1703
Chemistry
377
Dental
1351
Ear, Nose, Throat
250
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981
General & Plastic Surgery
2215
General Hospital
2065
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126
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100
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8
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474
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980
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439
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282
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2995
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52
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515
Radiology
2474
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155
Categories
LZA
Polymer Patient Examination Glove
415
LLZ
System, Image Processing,...
398
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Powered Laser Surgical Instrument
363
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Mask, Surgical
358
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Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
303
HRS
Plate, Fixation, Bone
287
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
225
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Vave Health, Inc.
Medical Device Manufacturer
·
US , San Mateo , CA
Vave Health, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2019
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Vave Health, Inc.
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Aug 30, 2024
Vave Wireless Ultrasound System
K241051
·
IYN
Radiology
·
135d
Cleared
Jul 10, 2019
Vave Personal Ultrasound System
K191541
·
IYO
Radiology
·
29d
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2
Radiology
2