510k
Database
Specialties
Anesthesiology
493
Cardiovascular
1525
Chemistry
348
Dental
1199
Ear, Nose, Throat
222
Gastroenterology & Urology
882
General & Plastic Surgery
2004
General Hospital
1544
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
437
Neurology
870
Obstetrics & Gynecology
386
Ophthalmic
254
Orthopedic
2604
Pathology
49
Physical Medicine
469
Radiology
2177
Toxicology
153
Categories
GEX
Powered Laser Surgical Instrument
326
LLZ
System, Image Processing,...
322
LZA
Polymer Patient Examination Glove
297
GEI
Electrosurgical, Cutting &...
279
QIH
Automated Radiological Image...
264
IYN
System, Imaging, Pulsed Doppler,...
261
HRS
Plate, Fixation, Bone
253
OLO
Orthopedic Stereotaxic Instrument
215
NHA
Abutment, Implant, Dental,...
201
MAX
Intervertebral Fusion Device...
186
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Suncoast Medical Manufacturers, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Suncoast Medical Manufacturers, Inc. - FDA 510(k) Cleared Devices
31 submissions
·
29 cleared
·
Since 1984
31
Total
29
Cleared
0
Denied
FDA 510(k) Regulatory Record - Suncoast Medical Manufacturers, Inc.
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
May 22, 1984
SUN-LITE WHITE SPOT
K841588
·
KYT
General Hospital
·
34d
Cleared
May 22, 1984
C-LITE
K841589
·
KYT
General Hospital
·
34d
Filters
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All
31
General & Plastic Surgery
18
Ophthalmic
10
General Hospital
2
Orthopedic
1