510k
Database
Specialties
Anesthesiology
331
Cardiovascular
1056
Chemistry
268
Dental
794
Ear, Nose, Throat
148
Gastroenterology & Urology
619
General & Plastic Surgery
1308
General Hospital
747
Hematology
97
Immunology
72
Medical Genetics
1
Microbiology
364
Neurology
567
Obstetrics & Gynecology
242
Ophthalmic
154
Orthopedic
2038
Pathology
38
Physical Medicine
309
Radiology
1575
Toxicology
131
Categories
GEX
Powered Laser Surgical Instrument
227
HRS
Plate, Fixation, Bone
208
IYN
System, Imaging, Pulsed Doppler,...
207
QIH
Automated Radiological Image...
205
LLZ
System, Image Processing,...
197
GEI
Electrosurgical, Cutting &...
185
OLO
Orthopedic Stereotaxic Instrument
168
NHA
Abutment, Implant, Dental,...
153
MAX
Intervertebral Fusion Device...
137
NKB
Thoracolumbosacral Pedicle Screw...
135
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Wako Chemicals USA, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Wako Chemicals USA, Inc. - FDA 510(k) Cleared Devices
124 submissions
·
123 cleared
·
Since 1981
124
Total
123
Cleared
1
Denied
FDA 510(k) Regulatory Record - Wako Chemicals USA, Inc.
Toxicology
✕
2
devices
1-2 of 2
Filters
Cleared
Feb 11, 2003
WAKO NEFA LINEARITY SET
K030065
·
JJX
Toxicology
·
35d
Cleared
Sep 12, 1997
WAKO NEFA LINEARITY SET
K973072
·
JJX
Toxicology
·
25d
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124
Chemistry
89
Immunology
30
Pathology
2
Toxicology
2
Hematology
1