510k
Database
Specialties
Anesthesiology
385
Cardiovascular
1200
Chemistry
294
Dental
891
Ear, Nose, Throat
164
Gastroenterology & Urology
706
General & Plastic Surgery
1519
General Hospital
900
Hematology
108
Immunology
78
Medical Genetics
1
Microbiology
391
Neurology
662
Obstetrics & Gynecology
283
Ophthalmic
175
Orthopedic
2191
Pathology
41
Physical Medicine
355
Radiology
1746
Toxicology
137
Categories
GEX
Powered Laser Surgical Instrument
253
QIH
Automated Radiological Image...
231
LLZ
System, Image Processing,...
226
IYN
System, Imaging, Pulsed Doppler,...
221
HRS
Plate, Fixation, Bone
217
GEI
Electrosurgical, Cutting &...
211
OLO
Orthopedic Stereotaxic Instrument
182
NHA
Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
149
MAX
Intervertebral Fusion Device...
146
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Gc Medtech, LLC
Medical Device Manufacturer
·
US , Lutsen , MN
Gc Medtech, LLC - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2014
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Gc Medtech, LLC
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
May 20, 2015
E-App
K142719
·
JAQ
Radiology
·
239d
Cleared
Apr 18, 2014
GENTLECARE AR APPLICATOR
K133922
·
JAQ
Radiology
·
116d
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2
Radiology
2