510k
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424
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1283
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314
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971
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184
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754
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1643
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1051
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114
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82
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407
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712
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315
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193
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2320
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43
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382
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1866
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139
Categories
GEX
Powered Laser Surgical Instrument
275
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System, Image Processing,...
260
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Automated Radiological Image...
243
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Plate, Fixation, Bone
229
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System, Imaging, Pulsed Doppler,...
229
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Electrosurgical, Cutting &...
228
OLO
Orthopedic Stereotaxic Instrument
188
NHA
Abutment, Implant, Dental,...
176
LZA
Polymer Patient Examination Glove
160
NKB
Thoracolumbosacral Pedicle Screw...
158
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Kontron Medical Systems Sas
Medical Device Manufacturer
·
US , Hasbrouck Heights , NJ
Kontron Medical Systems Sas - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2000
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Kontron Medical Systems Sas
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Jun 14, 2006
SIGMA 5000 SERIES, IMAGIC
K061437
·
IYN
Radiology
·
21d
Cleared
Nov 16, 2005
SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM
K053084
·
IYN
Radiology
·
14d
Cleared
Jan 28, 2005
SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM
K050099
·
IYN
Radiology
·
10d
Cleared
Aug 08, 2000
SIGMA 110/330 DIAGNOSTIC ULTRASOUND SYSTEM
K002239
·
IYN
Radiology
·
15d
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4
Radiology
4