510k
Database
Specialties
Anesthesiology
717
Cardiovascular
2187
Chemistry
478
Dental
1771
Ear, Nose, Throat
314
Gastroenterology & Urology
1242
General & Plastic Surgery
2748
General Hospital
2454
Hematology
157
Immunology
137
Medical Genetics
13
Microbiology
588
Neurology
1237
Obstetrics & Gynecology
565
Ophthalmic
378
Orthopedic
3830
Pathology
60
Physical Medicine
588
Radiology
3059
Toxicology
176
Categories
LLZ
System, Image Processing,...
518
LZA
Polymer Patient Examination Glove
454
GEX
Powered Laser Surgical Instrument
442
GEI
Electrosurgical, Cutting &...
399
FXX
Mask, Surgical
388
IYN
System, Imaging, Pulsed Doppler,...
364
HRS
Plate, Fixation, Bone
353
MAX
Intervertebral Fusion Device...
313
OLO
Orthopedic Stereotaxic Instrument
287
QIH
Automated Radiological Image...
286
Browse all 339 categories →
Search
Reports
Glossary
About
Search FDA 510(k) devices
Home
Manufacturers
SE
Directa AB
Medical Device Manufacturer
·
SE , Upplands Vasby
Directa AB - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2015
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Directa AB
Dental
✕
1
devices
1-1 of 1
Filters
Cleared
Nov 24, 2015
LUXATOR LX HANDPIECE
K133178
·
EGS
Dental
·
768d
Filters
Filter by Specialty
All
1
Dental
1