510k
Database
Specialties
Anesthesiology
5691
Cardiovascular
13465
Chemistry
10856
Dental
8834
Ear, Nose, Throat
2661
Gastroenterology & Urology
7157
General & Plastic Surgery
12360
General Hospital
10597
Hematology
2519
Immunology
3050
Medical Genetics
20
Microbiology
5837
Neurology
4258
Obstetrics & Gynecology
2890
Ophthalmic
2646
Orthopedic
15483
Pathology
833
Physical Medicine
2569
Radiology
11242
Toxicology
2543
Categories
GEX
Powered Laser Surgical Instrument
2087
GEI
Electrosurgical, Cutting &...
1673
LLZ
System, Image Processing,...
1603
HRS
Plate, Fixation, Bone
1165
DZE
Implant, Endosseous, Root-form
1111
IYN
System, Imaging, Pulsed Doppler,...
1039
GCJ
Laparoscope, General & Plastic...
1023
LZA
Polymer Patient Examination Glove
959
ESD
Hearing Aid, Air-conduction,...
953
LNH
System, Nuclear Magnetic...
943
Browse all 339 categories →
Manufacturers
Search
Reports
Glossary
About
Search FDA 510(k) devices
510k Database
Manufacturers
US
U&I Corp., America
Share
Medical Device Manufacturer
·
US , Murray , UT
U&I Corp., America - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2003
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - U&I Corp., America
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
Jun 27, 2003
U&I, OPTIMA, SPINAL SYSTEM
K031585
·
MNH
Orthopedic
·
37d
Cleared
Jun 24, 2003
U & I AMERICA SPINAL HOOK SYSTEM
K031595
·
KWP
Orthopedic
·
34d
Cleared
Mar 12, 2003
OPTIMA, SPINAL SYSTEM
K024096
·
MNI
Orthopedic
·
90d
Filters
Filter by Specialty
All
3
Orthopedic
3