510k
Database
Specialties
Anesthesiology
1037
Cardiovascular
4332
Chemistry
3210
Dental
2788
Ear, Nose, Throat
465
Gastroenterology & Urology
2371
General & Plastic Surgery
3996
General Hospital
3717
Hematology
788
Immunology
776
Medical Genetics
15
Microbiology
1404
Neurology
1755
Obstetrics & Gynecology
867
Ophthalmic
492
Orthopedic
7536
Pathology
165
Physical Medicine
963
Radiology
4605
Toxicology
1237
Categories
LLZ
System, Image Processing,...
725
HRS
Plate, Fixation, Bone
689
GEI
Electrosurgical, Cutting &...
562
IYN
System, Imaging, Pulsed Doppler,...
533
GEX
Powered Laser Surgical Instrument
519
LZA
Polymer Patient Examination Glove
489
JWH
Prosthesis, Knee,...
464
MAX
Intervertebral Fusion Device...
403
FXX
Mask, Surgical
400
HWC
Screw, Fixation, Bone
392
Browse all 339 categories →
Manufacturers
Search
Reports
Glossary
About
Search FDA 510(k) devices
Home
Manufacturers
JP
Denka Seiken'S
Medical Device Manufacturer
·
JP , Tokyo
Denka Seiken'S - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1998
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Denka Seiken'S
Microbiology
✕
2
devices
1-2 of 2
Filters
Cleared
Mar 27, 2002
MRSA-SCREEN
K011400
·
MYI
Microbiology
·
324d
Cleared
Sep 22, 1998
VTEC-RPLA SEIKEN
K981734
·
GNA
Microbiology
·
127d
Filters
Filter by Specialty
All
4
Microbiology
2
Chemistry
2