510k
Database
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Anesthesiology
1092
Cardiovascular
4436
Chemistry
3291
Dental
2794
Ear, Nose, Throat
468
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2431
General & Plastic Surgery
4114
General Hospital
3833
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805
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787
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15
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1732
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1772
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883
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497
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7695
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167
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963
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4789
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1239
Categories
LLZ
System, Image Processing,...
730
HRS
Plate, Fixation, Bone
690
GEI
Electrosurgical, Cutting &...
568
IYN
System, Imaging, Pulsed Doppler,...
535
GEX
Powered Laser Surgical Instrument
520
JWH
Prosthesis, Knee,...
493
LZA
Polymer Patient Examination Glove
489
LNH
System, Nuclear Magnetic...
431
MAX
Intervertebral Fusion Device...
406
FXX
Mask, Surgical
400
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Manufacturers
BE
Agfa Healthcare N.V.
Medical Device Manufacturer
·
BE , Mortsel
Agfa Healthcare N.V. - FDA 510(k) Cleared Devices
27 submissions
·
27 cleared
·
Since 2009
27
Total
27
Cleared
0
Denied
27
devices
26-27 of 27
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1
2
Cleared
Aug 11, 2009
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS
K092238
·
MQB
Radiology
·
19d
Cleared
May 18, 2009
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS
K090672
·
MQB
Radiology
·
66d
1
2
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27
Radiology
26
General & Plastic Surgery
1