510k
Database
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Anesthesiology
545
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1709
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380
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1353
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252
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981
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2215
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2069
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126
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100
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8
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474
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980
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441
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282
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3014
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52
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515
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2476
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155
Categories
LZA
Polymer Patient Examination Glove
416
LLZ
System, Image Processing,...
398
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Powered Laser Surgical Instrument
363
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Mask, Surgical
358
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Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
304
HRS
Plate, Fixation, Bone
290
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
233
MAX
Intervertebral Fusion Device...
228
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Ge Medical Systems Information Technologies GmbH
Medical Device Manufacturer
·
DE , Freiburg
Ge Medical Systems Information Technologies GmbH - FDA 510(k) Cleared...
3 submissions
·
3 cleared
·
Since 2000
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ge Medical Systems Information Technologies GmbH
Cardiovascular
✕
3
devices
1-3 of 3
Filters
Cleared
Feb 16, 2011
CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM
K103678
·
DQK
Cardiovascular
·
62d
Cleared
Jul 29, 2009
HEART-EXERCISE
K091594
·
MHX
Cardiovascular
·
57d
Cleared
Oct 30, 2000
RESPONDER 3000
K000638
·
MKJ
Cardiovascular
·
248d
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3
Cardiovascular
3