510k
Database
Specialties
Anesthesiology
456
Cardiovascular
1388
Chemistry
334
Dental
1080
Ear, Nose, Throat
198
Gastroenterology & Urology
822
General & Plastic Surgery
1819
General Hospital
1261
Hematology
124
Immunology
85
Medical Genetics
7
Microbiology
420
Neurology
777
Obstetrics & Gynecology
343
Ophthalmic
218
Orthopedic
2436
Pathology
46
Physical Medicine
416
Radiology
2006
Toxicology
143
Categories
GEX
Powered Laser Surgical Instrument
298
LLZ
System, Image Processing,...
291
GEI
Electrosurgical, Cutting &...
256
QIH
Automated Radiological Image...
253
IYN
System, Imaging, Pulsed Doppler,...
242
HRS
Plate, Fixation, Bone
237
LZA
Polymer Patient Examination Glove
216
OLO
Orthopedic Stereotaxic Instrument
199
NHA
Abutment, Implant, Dental,...
189
MAX
Intervertebral Fusion Device...
169
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Chester Labs, Inc.
Medical Device Manufacturer
·
US , Erlanger , KY
Chester Labs, Inc. - FDA 510(k) Cleared Devices
11 submissions
·
11 cleared
·
Since 1985
11
Total
11
Cleared
0
Denied
FDA 510(k) Regulatory Record - Chester Labs, Inc.
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Jun 21, 1995
GRAHAM-FIELD ULTRASOUND SCANNING GEL
K944597
·
IYO
Radiology
·
275d
Cleared
Jun 07, 1995
GRAHAM-FIELD ULTRASOUND LOTION
K944596
·
IMI
Radiology
·
261d
Filters
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11
Neurology
5
General Hospital
3
Radiology
2
General & Plastic Surgery
1