510k
Database
Specialties
Anesthesiology
545
Cardiovascular
1693
Chemistry
370
Dental
1351
Ear, Nose, Throat
250
Gastroenterology & Urology
979
General & Plastic Surgery
2211
General Hospital
2055
Hematology
126
Immunology
100
Medical Genetics
8
Microbiology
473
Neurology
980
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438
Ophthalmic
280
Orthopedic
2980
Pathology
52
Physical Medicine
515
Radiology
2466
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
411
LLZ
System, Image Processing,...
398
GEX
Powered Laser Surgical Instrument
361
FXX
Mask, Surgical
358
GEI
Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
283
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
224
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Sorex Medical
Medical Device Manufacturer
·
US , Salt Lake City , UT
Sorex Medical - FDA 510(k) Cleared Devices
9 submissions
·
6 cleared
·
Since 1989
9
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sorex Medical
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Sep 06, 1991
PLUME MASTER
K913036
·
FYD
General Hospital
·
59d
Cleared
Jul 05, 1991
PICC-FIX
K911070
·
KMK
General Hospital
·
116d
Cleared
Apr 05, 1991
PICC INSERTION KIT/P.I.C. & PICC EXCHANG KIT/P.E.K
K910315
·
LJS
General Hospital
·
71d
Filters
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9
General & Plastic Surgery
4
General Hospital
3
Gastroenterology & Urology
1
Anesthesiology
1