510k
Database
Specialties
Anesthesiology
494
Cardiovascular
1533
Chemistry
349
Dental
1208
Ear, Nose, Throat
223
Gastroenterology & Urology
889
General & Plastic Surgery
2016
General Hospital
1567
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
438
Neurology
878
Obstetrics & Gynecology
387
Ophthalmic
255
Orthopedic
2616
Pathology
49
Physical Medicine
474
Radiology
2191
Toxicology
153
Categories
GEX
Powered Laser Surgical Instrument
329
LLZ
System, Image Processing,...
326
LZA
Polymer Patient Examination Glove
304
GEI
Electrosurgical, Cutting &...
281
QIH
Automated Radiological Image...
266
IYN
System, Imaging, Pulsed Doppler,...
261
HRS
Plate, Fixation, Bone
254
OLO
Orthopedic Stereotaxic Instrument
215
NHA
Abutment, Implant, Dental,...
202
MAX
Intervertebral Fusion Device...
189
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Berkeley Bio-Engineering
Medical Device Manufacturer
·
US , Mchenry , IL
Berkeley Bio-Engineering - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1977
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Berkeley Bio-Engineering
Orthopedic
✕
1
devices
1-1 of 1
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Cleared
Apr 23, 1979
ENDOTOME
K790645
·
HSZ
Orthopedic
·
24d
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4
Ophthalmic
2
Obstetrics & Gynecology
1
Orthopedic
1