510k
Database
Specialties
Anesthesiology
519
Cardiovascular
1600
Chemistry
356
Dental
1297
Ear, Nose, Throat
234
Gastroenterology & Urology
927
General & Plastic Surgery
2126
General Hospital
1959
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
938
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425
Ophthalmic
271
Orthopedic
2691
Pathology
52
Physical Medicine
511
Radiology
2316
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
401
LLZ
System, Image Processing,...
366
GEX
Powered Laser Surgical Instrument
349
FXX
Mask, Surgical
337
GEI
Electrosurgical, Cutting &...
293
QIH
Automated Radiological Image...
273
IYN
System, Imaging, Pulsed Doppler,...
264
HRS
Plate, Fixation, Bone
261
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
205
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Verge Medical, Inc.
Medical Device Manufacturer
·
US , Campbell , CA
Verge Medical, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2026
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Verge Medical, Inc.
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 02, 2026
FLASH Flex™ Aorto-Ostial Angioplasty System
K254022
·
LOX
Cardiovascular
·
107d
Cleared
Jan 21, 2026
RoVo Mechanical Thrombectomy System
K253730
·
QEW
Cardiovascular
·
58d
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Cardiovascular
2