510k
Database
Specialties
Anesthesiology
538
Cardiovascular
1656
Chemistry
360
Dental
1323
Ear, Nose, Throat
244
Gastroenterology & Urology
957
General & Plastic Surgery
2176
General Hospital
2038
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
462
Neurology
959
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2844
Pathology
52
Physical Medicine
515
Radiology
2413
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
382
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
214
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Vygon Corp.
Medical Device Manufacturer
·
US , East Rutherford , NJ
Vygon Corp. - FDA 510(k) Cleared Devices
48 submissions
·
46 cleared
·
Since 1985
48
Total
46
Cleared
0
Denied
FDA 510(k) Regulatory Record - Vygon Corp.
Cardiovascular
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 27, 2005
VYGON MICRO-ACCESS SAFETY INTRODUCER KIT
K051248
·
DYB
Cardiovascular
·
164d
Cleared
Sep 28, 2001
VYGON SPLIT CANNULA INTRODUCER
K010913
·
DYB
Cardiovascular
·
185d
Cleared
Apr 28, 1987
MULTICATH - CODE#S 8.1207.OO/8.1208.00/8.1205.20
K870067
·
DQY
Cardiovascular
·
110d
Filters
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All
48
General Hospital
25
Gastroenterology & Urology
9
Anesthesiology
6
General & Plastic Surgery
3
Cardiovascular
3
Toxicology
2