510k
Database
Specialties
Anesthesiology
7877
Cardiovascular
16735
Chemistry
12180
Dental
11639
Ear, Nose, Throat
3416
Gastroenterology & Urology
9067
General & Plastic Surgery
16834
General Hospital
15472
Hematology
2935
Immunology
3444
Medical Genetics
20
Microbiology
6421
Neurology
5757
Obstetrics & Gynecology
4096
Ophthalmic
4444
Orthopedic
17714
Pathology
953
Physical Medicine
4530
Radiology
14742
Toxicology
2882
Categories
Powered Laser Surgical Instrument
GEX
2837
System, Image Processing, Radiological
LLZ
2271
Electrosurgical, Cutting &...
GEI
2233
Implant, Endosseous, Root-form
DZE
1503
Laparoscope, General & Plastic Surgery
GCJ
1429
Latex Patient Examination Glove
LYY
1364
Plate, Fixation, Bone
HRS
1324
Polymer Patient Examination Glove
LZA
1178
System, Imaging, Pulsed Doppler,...
IYN
1173
Hearing Aid, Air-conduction,...
ESD
1154
Browse all 339 categories →
Manufacturers
Search
Reports
Glossary
About
Search FDA 510(k) devices
510k Database
Manufacturers
US
Biolectron, Inc.
Share
Medical Device Manufacturer
·
US , Hackensack , NJ
Biolectron, Inc. - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 1997
Recent clearances:
CURVTEK TSR SYSTEM
View 1 510(k) Devices ↓
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Biolectron, Inc.
Orthopedic
✕
1
devices
1-1 of 1
Filters
Cleared
Oct 31, 1997
CURVTEK TSR SYSTEM
K972860
·
HSZ
Orthopedic
·
88d
Filters
Filter by Specialty
All
1
Orthopedic
1