510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1684
Chemistry
370
Dental
1341
Ear, Nose, Throat
250
Gastroenterology & Urology
979
General & Plastic Surgery
2202
General Hospital
2052
Hematology
126
Immunology
100
Medical Genetics
8
Microbiology
472
Neurology
973
Obstetrics & Gynecology
436
Ophthalmic
279
Orthopedic
2966
Pathology
52
Physical Medicine
515
Radiology
2457
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
391
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
282
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
221
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Shiley, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Shiley, Inc. - FDA 510(k) Cleared Devices
174 submissions
·
174 cleared
·
Since 1976
174
Total
174
Cleared
0
Denied
FDA 510(k) Regulatory Record - Shiley, Inc.
General & Plastic Surgery
✕
1
devices
1-1 of 1
Filters
Cleared
Jun 22, 1978
IRRIGATION CATHETER
K780788
·
GBX
General & Plastic Surgery
·
38d
Filters
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All
174
Cardiovascular
120
Anesthesiology
39
Gastroenterology & Urology
8
General Hospital
3
Ear, Nose, Throat
3
General & Plastic Surgery
1