510k
Database
Specialties
Anesthesiology
479
Cardiovascular
1453
Chemistry
338
Dental
1148
Ear, Nose, Throat
213
Gastroenterology & Urology
845
General & Plastic Surgery
1904
General Hospital
1447
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
427
Neurology
821
Obstetrics & Gynecology
363
Ophthalmic
239
Orthopedic
2501
Pathology
49
Physical Medicine
439
Radiology
2072
Toxicology
146
Categories
GEX
Powered Laser Surgical Instrument
310
LLZ
System, Image Processing,...
306
LZA
Polymer Patient Examination Glove
279
GEI
Electrosurgical, Cutting &...
261
QIH
Automated Radiological Image...
256
HRS
Plate, Fixation, Bone
247
IYN
System, Imaging, Pulsed Doppler,...
247
OLO
Orthopedic Stereotaxic Instrument
206
NHA
Abutment, Implant, Dental,...
193
MAX
Intervertebral Fusion Device...
174
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Radionics Medical, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Radionics Medical, Inc. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 1981
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Radionics Medical, Inc.
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Apr 18, 1985
CORNEOMAP 4500
K844299
·
IYO
Radiology
·
162d
Cleared
Nov 28, 1983
SINUSVU 2500
K833222
·
IYO
Radiology
·
101d
Cleared
May 09, 1983
CORNEOMAP 4500 ULTRASOUND MEASUREMENT
K837331
Radiology
·
60d
Cleared
Jul 22, 1982
OCULAR BIOMETER 4000
K827035
Radiology
·
90d
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5
Radiology
4
Cardiovascular
1