510k
Database
Specialties
Anesthesiology
553
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1736
Chemistry
387
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1407
Ear, Nose, Throat
258
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997
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2244
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2105
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127
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105
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8
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477
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988
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452
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286
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3087
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52
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517
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2517
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156
Categories
LZA
Polymer Patient Examination Glove
423
LLZ
System, Image Processing,...
402
GEX
Powered Laser Surgical Instrument
366
FXX
Mask, Surgical
361
GEI
Electrosurgical, Cutting &...
313
IYN
System, Imaging, Pulsed Doppler,...
306
HRS
Plate, Fixation, Bone
300
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
238
MAX
Intervertebral Fusion Device...
235
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Sectra AB
Medical Device Manufacturer
·
US , Aubrey , TX
Sectra AB - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2000
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sectra AB
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 09, 2004
SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE
K034059
·
LLZ
Radiology
·
69d
Cleared
Oct 29, 2003
SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1
K033088
·
LLZ
Radiology
·
30d
Cleared
May 03, 2000
IDS5 IMAGE DISPLAY SYSTEM
K001140
·
LLZ
Radiology
·
23d
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5
Radiology
3
Pathology
2