510k
Database
Specialties
Anesthesiology
338
Cardiovascular
1074
Chemistry
272
Dental
826
Ear, Nose, Throat
149
Gastroenterology & Urology
638
General & Plastic Surgery
1338
General Hospital
773
Hematology
100
Immunology
72
Medical Genetics
1
Microbiology
368
Neurology
589
Obstetrics & Gynecology
249
Ophthalmic
156
Orthopedic
2064
Pathology
40
Physical Medicine
312
Radiology
1596
Toxicology
132
Categories
GEX
Powered Laser Surgical Instrument
231
HRS
Plate, Fixation, Bone
211
IYN
System, Imaging, Pulsed Doppler,...
209
QIH
Automated Radiological Image...
208
LLZ
System, Image Processing,...
199
GEI
Electrosurgical, Cutting &...
186
OLO
Orthopedic Stereotaxic Instrument
170
NHA
Abutment, Implant, Dental,...
162
NKB
Thoracolumbosacral Pedicle Screw...
138
MAX
Intervertebral Fusion Device...
138
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American Dade
Medical Device Manufacturer
·
US , Mchenry , IL
American Dade - FDA 510(k) Cleared Devices
149 submissions
·
149 cleared
·
Since 1980
149
Total
149
Cleared
0
Denied
FDA 510(k) Regulatory Record - American Dade
Microbiology
✕
1
devices
1-1 of 1
Filters
Cleared
May 15, 1981
DADE RPR CARD TEST
K811152
·
GMQ
Microbiology
·
18d
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All
149
Chemistry
83
Hematology
46
Toxicology
10
Immunology
8
Microbiology
1
Pathology
1