510k
Database
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Anesthesiology
471
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1414
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334
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1117
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208
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833
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1869
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1369
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124
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87
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8
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423
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805
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354
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232
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2464
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48
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429
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2038
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144
Categories
GEX
Powered Laser Surgical Instrument
303
LLZ
System, Image Processing,...
300
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Electrosurgical, Cutting &...
258
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Automated Radiological Image...
255
LZA
Polymer Patient Examination Glove
250
IYN
System, Imaging, Pulsed Doppler,...
245
HRS
Plate, Fixation, Bone
243
OLO
Orthopedic Stereotaxic Instrument
202
NHA
Abutment, Implant, Dental,...
190
MAX
Intervertebral Fusion Device...
171
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Bruel & Kjaer
Medical Device Manufacturer
·
DK , Naerum 2850
Bruel & Kjaer - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1991
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bruel & Kjaer
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Aug 28, 1991
DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535
K905198
·
IYN
Radiology
·
281d
Cleared
Jun 21, 1991
RIGID ENDOSCOPE
K911348
·
LNH
Radiology
·
86d
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4
Radiology
2
Anesthesiology
2