510k
Database
Specialties
Anesthesiology
341
Cardiovascular
1095
Chemistry
278
Dental
832
Ear, Nose, Throat
150
Gastroenterology & Urology
649
General & Plastic Surgery
1351
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796
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100
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72
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1
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371
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596
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252
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160
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2080
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40
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322
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1625
Toxicology
132
Categories
GEX
Powered Laser Surgical Instrument
234
IYN
System, Imaging, Pulsed Doppler,...
213
HRS
Plate, Fixation, Bone
211
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Automated Radiological Image...
211
LLZ
System, Image Processing,...
202
GEI
Electrosurgical, Cutting &...
187
OLO
Orthopedic Stereotaxic Instrument
171
NHA
Abutment, Implant, Dental,...
162
NKB
Thoracolumbosacral Pedicle Screw...
140
MAX
Intervertebral Fusion Device...
139
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Boston Scientific Corporation Northwest Technology
Medical Device Manufacturer
·
US , Redmond , WA
Boston Scientific Corporation Northwest Technology - FDA 510(k) Clear...
2 submissions
·
2 cleared
·
Since 1999
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Boston Scientific Corporation Northwest Technology
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 01, 2000
WIRECLIP TORQUER
K003398
·
DQX
Cardiovascular
·
30d
Cleared
Nov 24, 1999
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER
K993648
·
MCW
Cardiovascular
·
26d
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Cardiovascular
2