510k
Database
Specialties
Anesthesiology
669
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2044
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452
Dental
1655
Ear, Nose, Throat
298
Gastroenterology & Urology
1160
General & Plastic Surgery
2556
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2331
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142
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125
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12
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558
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1149
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521
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348
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3618
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57
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557
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2898
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165
Categories
LLZ
System, Image Processing,...
475
LZA
Polymer Patient Examination Glove
439
GEX
Powered Laser Surgical Instrument
417
FXX
Mask, Surgical
386
GEI
Electrosurgical, Cutting &...
367
IYN
System, Imaging, Pulsed Doppler,...
353
HRS
Plate, Fixation, Bone
338
QIH
Automated Radiological Image...
285
MAX
Intervertebral Fusion Device...
282
OLO
Orthopedic Stereotaxic Instrument
275
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Manufacturers
US
Nxstage Medical, Inc.
Medical Device Manufacturer
·
US , Tewksburt , MA
Nxstage Medical, Inc. - FDA 510(k) Cleared Devices
51 submissions
·
51 cleared
·
Since 2001
51
Total
51
Cleared
0
Denied
51
devices
51-51 of 51
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2
3
Cleared
Jan 17, 2001
LIFEMATE HEMOFILTRATION SYSTEM
K001283
·
KDI
Gastroenterology & Urology
·
271d
1
2
3
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51
Gastroenterology & Urology
50
General Hospital
1