510k
Database
Specialties
Anesthesiology
361
Cardiovascular
1140
Chemistry
284
Dental
854
Ear, Nose, Throat
153
Gastroenterology & Urology
669
General & Plastic Surgery
1417
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835
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105
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76
Medical Genetics
1
Microbiology
376
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627
Obstetrics & Gynecology
259
Ophthalmic
165
Orthopedic
2141
Pathology
40
Physical Medicine
342
Radiology
1673
Toxicology
133
Categories
GEX
Powered Laser Surgical Instrument
241
QIH
Automated Radiological Image...
221
HRS
Plate, Fixation, Bone
216
IYN
System, Imaging, Pulsed Doppler,...
216
LLZ
System, Image Processing,...
208
GEI
Electrosurgical, Cutting &...
195
OLO
Orthopedic Stereotaxic Instrument
179
NHA
Abutment, Implant, Dental,...
166
NKB
Thoracolumbosacral Pedicle Screw...
147
MAX
Intervertebral Fusion Device...
145
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LeMaitre Vascular, Inc.
Medical Device Manufacturer
·
US , Burlington , MA
LeMaitre Vascular, Inc. - FDA 510(k) Cleared Devices
32 submissions
·
32 cleared
·
Since 2003
32
Total
32
Cleared
0
Denied
FDA 510(k) Regulatory Record - LeMaitre Vascular, Inc.
Neurology
✕
1
devices
1-1 of 1
Filters
Cleared
Jun 13, 2019
XenoSure Dura Biologic Patch
K183513
·
GXQ
Neurology
·
177d
Filters
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32
Cardiovascular
25
General & Plastic Surgery
4
General Hospital
2
Neurology
1