510k
Database
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Anesthesiology
438
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1336
Chemistry
330
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1032
Ear, Nose, Throat
192
Gastroenterology & Urology
794
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1750
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1156
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117
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84
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7
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414
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746
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329
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204
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2394
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44
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400
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1931
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141
Categories
GEX
Powered Laser Surgical Instrument
285
LLZ
System, Image Processing,...
275
GEI
Electrosurgical, Cutting &...
248
QIH
Automated Radiological Image...
247
IYN
System, Imaging, Pulsed Doppler,...
236
HRS
Plate, Fixation, Bone
232
OLO
Orthopedic Stereotaxic Instrument
197
LZA
Polymer Patient Examination Glove
185
NHA
Abutment, Implant, Dental,...
184
MAX
Intervertebral Fusion Device...
165
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Scanditronix Wellhofer North America
Medical Device Manufacturer
·
US , Bartlett , TN
Scanditronix Wellhofer North America - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2000
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Scanditronix Wellhofer North America
Radiology
✕
1
devices
1-1 of 1
Filters
Cleared
Aug 18, 2000
DOSE 1
K000209
·
IYE
Radiology
·
207d
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1
Radiology
1