510k
Database
Specialties
Anesthesiology
338
Cardiovascular
1073
Chemistry
272
Dental
822
Ear, Nose, Throat
149
Gastroenterology & Urology
636
General & Plastic Surgery
1334
General Hospital
768
Hematology
100
Immunology
72
Medical Genetics
1
Microbiology
367
Neurology
589
Obstetrics & Gynecology
247
Ophthalmic
155
Orthopedic
2062
Pathology
40
Physical Medicine
311
Radiology
1591
Toxicology
132
Categories
GEX
Powered Laser Surgical Instrument
231
HRS
Plate, Fixation, Bone
211
IYN
System, Imaging, Pulsed Doppler,...
209
QIH
Automated Radiological Image...
208
LLZ
System, Image Processing,...
199
GEI
Electrosurgical, Cutting &...
186
OLO
Orthopedic Stereotaxic Instrument
170
NHA
Abutment, Implant, Dental,...
161
MAX
Intervertebral Fusion Device...
138
NKB
Thoracolumbosacral Pedicle Screw...
137
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Boston Scientific Corporation
Medical Device Manufacturer
·
US , Marlborough , MA
Boston Scientific Corporation - FDA 510(k) Cleared Devices
229 submissions
·
216 cleared
·
Since 2005
Official Website
229
Total
216
Cleared
1
Denied
FDA 510(k) Regulatory Record - Boston Scientific Corporation
General Hospital
✕
1
devices
1-1 of 1
Filters
Cleared
Feb 21, 2022
EndoArmor™ + Surgical Gown
K203548
·
FYA
General Hospital
·
444d
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All
229
Cardiovascular
100
Gastroenterology & Urology
97
Obstetrics & Gynecology
7
General & Plastic Surgery
7
Ear, Nose, Throat
6
Radiology
5
Anesthesiology
4
Orthopedic
1
Neurology
1
General Hospital
1