510k
Database
Specialties
Anesthesiology
436
Cardiovascular
1334
Chemistry
328
Dental
1028
Ear, Nose, Throat
192
Gastroenterology & Urology
791
General & Plastic Surgery
1744
General Hospital
1146
Hematology
117
Immunology
84
Medical Genetics
7
Microbiology
413
Neurology
744
Obstetrics & Gynecology
327
Ophthalmic
203
Orthopedic
2390
Pathology
44
Physical Medicine
398
Radiology
1928
Toxicology
141
Categories
GEX
Powered Laser Surgical Instrument
285
LLZ
System, Image Processing,...
274
GEI
Electrosurgical, Cutting &...
247
QIH
Automated Radiological Image...
247
IYN
System, Imaging, Pulsed Doppler,...
235
HRS
Plate, Fixation, Bone
232
OLO
Orthopedic Stereotaxic Instrument
196
LZA
Polymer Patient Examination Glove
183
NHA
Abutment, Implant, Dental,...
183
MAX
Intervertebral Fusion Device...
165
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Showa Ika Kohgyo Co., Ltd.
Medical Device Manufacturer
·
US , San Diego, , CA
Showa Ika Kohgyo Co., Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2006
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Showa Ika Kohgyo Co., Ltd.
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Jul 02, 2008
MYKRES SPINAL SYSTEM
K071074
·
MNI
Orthopedic
·
443d
Cleared
Jul 03, 2006
MYKRES SPINAL SYSTEM
K051704
·
MNI
Orthopedic
·
374d
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Orthopedic
2