510k
Database
Specialties
Anesthesiology
1509
Cardiovascular
5408
Chemistry
4504
Dental
3250
Ear, Nose, Throat
537
Gastroenterology & Urology
2867
General & Plastic Surgery
4719
General Hospital
4187
Hematology
1087
Immunology
1351
Medical Genetics
15
Microbiology
2521
Neurology
2003
Obstetrics & Gynecology
1009
Ophthalmic
556
Orthopedic
8419
Pathology
353
Physical Medicine
1033
Radiology
5501
Toxicology
1362
Categories
LLZ
System, Image Processing,...
798
HRS
Plate, Fixation, Bone
698
GEI
Electrosurgical, Cutting &...
695
IYN
System, Imaging, Pulsed Doppler,...
632
GEX
Powered Laser Surgical Instrument
536
JWH
Prosthesis, Knee,...
522
LNH
System, Nuclear Magnetic...
494
LZA
Polymer Patient Examination Glove
490
MAX
Intervertebral Fusion Device...
465
NKB
Thoracolumbosacral Pedicle Screw...
448
Browse all 339 categories →
Manufacturers
Search
Reports
Glossary
About
Search FDA 510(k) devices
510k Database
Manufacturers
US
Neauvia North America, Inc.
Medical Device Manufacturer
·
US , Raliegh , NC
Neauvia North America, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2020
Recent clearances:
Plasma IQ
,
Plasma IQ
,
Plasma IQ
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Neauvia North America, Inc.
General & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
Jan 17, 2023
Plasma IQ
K223222
·
GEI
General & Plastic Surgery
·
92d
Cleared
Dec 09, 2021
Plasma IQ
K212329
·
GEI
General & Plastic Surgery
·
135d
Cleared
Mar 06, 2020
Plasma IQ
K192813
·
GEI
General & Plastic Surgery
·
157d
Filters
Filter by Specialty
All
3
General & Plastic Surgery
3