510k
Database
Specialties
Anesthesiology
534
Cardiovascular
1649
Chemistry
359
Dental
1323
Ear, Nose, Throat
243
Gastroenterology & Urology
956
General & Plastic Surgery
2174
General Hospital
2038
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
462
Neurology
954
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2828
Pathology
52
Physical Medicine
515
Radiology
2403
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
381
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
209
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Centers For Disease Control and Prevention
Medical Device Manufacturer
·
US , Mchenry , IL
Centers For Disease Control and Prevention - FDA 510(k) Cleared Devic...
29 submissions
·
25 cleared
·
Since 1981
29
Total
25
Cleared
4
Denied
28
devices
26-28 of 28
Filters
1
2
Cleared
Oct 26, 1982
SERA FOR ANTINUCLEAR ANTIBODIES
K820945
·
DHN
Microbiology
·
203d
Cleared
Sep 08, 1981
LEGIONELLA DIRECT FLUORESCENT ANTIBODY
K812006
·
LHL
Microbiology
·
54d
Cleared
Sep 08, 1981
LEGIONELLA INDIRECT FLUOR. ANTIBODY
K812007
·
LHL
Microbiology
·
54d
1
2
Filters
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29
Microbiology
28
Toxicology
1