510k
Database
Specialties
Anesthesiology
491
Cardiovascular
1505
Chemistry
344
Dental
1188
Ear, Nose, Throat
219
Gastroenterology & Urology
865
General & Plastic Surgery
1966
General Hospital
1525
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
436
Neurology
862
Obstetrics & Gynecology
378
Ophthalmic
252
Orthopedic
2585
Pathology
49
Physical Medicine
461
Radiology
2157
Toxicology
153
Categories
LLZ
System, Image Processing,...
319
GEX
Powered Laser Surgical Instrument
319
LZA
Polymer Patient Examination Glove
295
GEI
Electrosurgical, Cutting &...
275
QIH
Automated Radiological Image...
263
IYN
System, Imaging, Pulsed Doppler,...
258
HRS
Plate, Fixation, Bone
251
OLO
Orthopedic Stereotaxic Instrument
215
NHA
Abutment, Implant, Dental,...
201
MAX
Intervertebral Fusion Device...
183
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Sutter Biomedical, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Sutter Biomedical, Inc. - FDA 510(k) Cleared Devices
11 submissions
·
11 cleared
·
Since 1981
11
Total
11
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sutter Biomedical, Inc.
General & Plastic Surgery
✕
1
devices
1-1 of 1
Filters
Cleared
Nov 16, 1981
SILICONE IMPLANTS
K812691
·
MDM
General & Plastic Surgery
·
55d
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11
Orthopedic
5
Physical Medicine
5
General & Plastic Surgery
1