510k
Database
Specialties
Anesthesiology
4807
Cardiovascular
11755
Chemistry
10253
Dental
7488
Ear, Nose, Throat
2310
Gastroenterology & Urology
6158
General & Plastic Surgery
10243
General Hospital
8479
Hematology
2336
Immunology
2902
Medical Genetics
18
Microbiology
5483
Neurology
3520
Obstetrics & Gynecology
2288
Ophthalmic
1910
Orthopedic
14038
Pathology
787
Physical Medicine
2011
Radiology
9532
Toxicology
2407
Categories
GEX
Powered Laser Surgical Instrument
1752
GEI
Electrosurgical, Cutting &...
1404
LLZ
System, Image Processing,...
1272
HRS
Plate, Fixation, Bone
1054
IYN
System, Imaging, Pulsed Doppler,...
945
DZE
Implant, Endosseous, Root-form
889
ESD
Hearing Aid, Air-conduction,...
882
LNH
System, Nuclear Magnetic...
876
GCJ
Laparoscope, General & Plastic...
860
JWH
Prosthesis, Knee,...
847
Browse all 339 categories →
Manufacturers
Search
Reports
Glossary
About
Search FDA 510(k) devices
510k Database
Manufacturers
US
Qualgenix, LLC
Medical Device Manufacturer
·
US , Oxford , CT
Qualgenix, LLC - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2012
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Qualgenix, LLC
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Jun 20, 2012
BLUE MOUNTAIN CERVICAL PLATE
K112809
·
KWQ
Orthopedic
·
267d
Cleared
Apr 18, 2012
TWIN PEAKS LUMBAR CAGE
K112696
·
MAX
Orthopedic
·
216d
Filters
Filter by Specialty
All
2
Orthopedic
2