510k
Database
Specialties
Anesthesiology
417
Cardiovascular
1259
Chemistry
311
Dental
958
Ear, Nose, Throat
181
Gastroenterology & Urology
750
General & Plastic Surgery
1625
General Hospital
1010
Hematology
114
Immunology
80
Medical Genetics
6
Microbiology
405
Neurology
702
Obstetrics & Gynecology
310
Ophthalmic
189
Orthopedic
2286
Pathology
43
Physical Medicine
379
Radiology
1840
Toxicology
138
Categories
GEX
Powered Laser Surgical Instrument
272
LLZ
System, Image Processing,...
256
QIH
Automated Radiological Image...
240
GEI
Electrosurgical, Cutting &...
226
IYN
System, Imaging, Pulsed Doppler,...
226
HRS
Plate, Fixation, Bone
225
OLO
Orthopedic Stereotaxic Instrument
188
NHA
Abutment, Implant, Dental,...
173
NKB
Thoracolumbosacral Pedicle Screw...
155
LZA
Polymer Patient Examination Glove
153
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Ep Medsystems
Medical Device Manufacturer
·
US , West Berlin , NJ
Ep Medsystems - FDA 510(k) Cleared Devices
12 submissions
·
12 cleared
·
Since 1996
12
Total
12
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ep Medsystems
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 11, 2008
MODIFICATION TO VIEWMATE SYSTEM
K073709
·
IYN
Radiology
·
71d
Cleared
May 01, 2007
VIEWMATE SYSTEM
K071028
·
ITN
Radiology
·
20d
Cleared
Oct 17, 2003
VIEWMATE ULTRASOUND IMAGING SYSTEM
K031066
·
IYN
Radiology
·
197d
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12
Cardiovascular
9
Radiology
3