510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1660
Chemistry
362
Dental
1333
Ear, Nose, Throat
244
Gastroenterology & Urology
958
General & Plastic Surgery
2183
General Hospital
2039
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
466
Neurology
962
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2868
Pathology
52
Physical Medicine
515
Radiology
2428
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
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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Merit Medical System, Inc.
Medical Device Manufacturer
·
IE , Galway
Merit Medical System, Inc. - FDA 510(k) Cleared Devices
5 submissions
·
4 cleared
·
Since 2020
5
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Merit Medical System, Inc.
General & Plastic Surgery
✕
1
devices
1-1 of 1
Filters
Cleared
Feb 12, 2024
SCOUT MD Surgical Guidance System
K231468
·
NEU
General & Plastic Surgery
·
266d
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5
Cardiovascular
4
General & Plastic Surgery
1