510k
Database
Specialties
Anesthesiology
456
Cardiovascular
1383
Chemistry
334
Dental
1080
Ear, Nose, Throat
198
Gastroenterology & Urology
821
General & Plastic Surgery
1817
General Hospital
1259
Hematology
123
Immunology
85
Medical Genetics
7
Microbiology
420
Neurology
775
Obstetrics & Gynecology
341
Ophthalmic
217
Orthopedic
2435
Pathology
46
Physical Medicine
416
Radiology
2003
Toxicology
143
Categories
GEX
Powered Laser Surgical Instrument
297
LLZ
System, Image Processing,...
290
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
215
OLO
Orthopedic Stereotaxic Instrument
199
NHA
Abutment, Implant, Dental,...
189
MAX
Intervertebral Fusion Device...
169
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Emix U.S.A., Inc.
Medical Device Manufacturer
·
US , King Of Prussia , PA
Emix U.S.A., Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 1994
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Emix U.S.A., Inc.
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Jul 20, 1995
LUMIX 70B
K951734
·
EAP
Radiology
·
97d
Cleared
Jul 18, 1994
VELO ACE
K940540
·
IXW
Radiology
·
161d
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2
Radiology
2