510k
Database
Specialties
Anesthesiology
691
Cardiovascular
2105
Chemistry
461
Dental
1700
Ear, Nose, Throat
305
Gastroenterology & Urology
1204
General & Plastic Surgery
2633
General Hospital
2385
Hematology
148
Immunology
130
Medical Genetics
13
Microbiology
573
Neurology
1196
Obstetrics & Gynecology
541
Ophthalmic
358
Orthopedic
3748
Pathology
57
Physical Medicine
572
Radiology
2970
Toxicology
169
Categories
LLZ
System, Image Processing,...
490
LZA
Polymer Patient Examination Glove
447
GEX
Powered Laser Surgical Instrument
431
GEI
Electrosurgical, Cutting &...
387
FXX
Mask, Surgical
386
IYN
System, Imaging, Pulsed Doppler,...
359
HRS
Plate, Fixation, Bone
345
MAX
Intervertebral Fusion Device...
299
OLO
Orthopedic Stereotaxic Instrument
285
QIH
Automated Radiological Image...
285
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Manufacturers
FR
Alseal
Medical Device Manufacturer
·
FR , Besancon
Alseal - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2012
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Alseal
Cardiovascular
✕
3
devices
1-3 of 3
Filters
Cleared
Aug 25, 2016
HQS Introducer (Model 2064-HQS)
K153494
·
DYB
Cardiovascular
·
265d
Cleared
Feb 14, 2014
XCATH
K133296
·
DYB
Cardiovascular
·
112d
Cleared
Jul 31, 2012
HQS INTRODUCER
K113849
·
DYB
Cardiovascular
·
215d
Filters
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3
Cardiovascular
3