510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1663
Chemistry
362
Dental
1334
Ear, Nose, Throat
244
Gastroenterology & Urology
963
General & Plastic Surgery
2184
General Hospital
2043
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
466
Neurology
963
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2875
Pathology
52
Physical Medicine
515
Radiology
2430
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
383
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
219
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Volta Medical
Medical Device Manufacturer
·
FR , Marseille
Volta Medical - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2020
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Volta Medical
Cardiovascular
✕
5
devices
1-5 of 5
Filters
Cleared
Sep 12, 2025
Volta AF-Xplorer II
K251518
·
DQK
Cardiovascular
·
119d
Cleared
CT
May 09, 2025
Volta AF-Xplorer
K243812
·
DQK
Cardiovascular
·
149d
Cleared
Sep 27, 2023
Volta AF-Xplorer
K232616
·
DQK
Cardiovascular
·
30d
Cleared
Jan 21, 2023
VX1+
K223516
·
DQK
Cardiovascular
·
60d
Cleared
Sep 16, 2020
VX1
K201298
·
DQK
Cardiovascular
·
124d
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5
Cardiovascular
5