510k
Database
Specialties
Anesthesiology
511
Cardiovascular
1590
Chemistry
356
Dental
1282
Ear, Nose, Throat
234
Gastroenterology & Urology
922
General & Plastic Surgery
2112
General Hospital
1890
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126
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91
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8
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449
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931
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422
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267
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2683
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51
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507
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2297
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154
Categories
LZA
Polymer Patient Examination Glove
392
LLZ
System, Image Processing,...
358
GEX
Powered Laser Surgical Instrument
348
GEI
Electrosurgical, Cutting &...
292
FXX
Mask, Surgical
289
QIH
Automated Radiological Image...
272
IYN
System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
261
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
204
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Te ME NA Sas
Medical Device Manufacturer
·
US , Apollo Beach , FL
Te ME NA Sas - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2006
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Te ME NA Sas
Anesthesiology
✕
2
devices
1-2 of 2
Filters
Cleared
Aug 05, 2008
HYBRID NERVE LOCATION NEEDLE COATED AND UNCOATED
K080603
·
BSP
Anesthesiology
·
155d
Cleared
Jul 18, 2006
POLYPLEX STIMULATING CATHETER SYSTEM
K060186
·
CAZ
Anesthesiology
·
175d
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Anesthesiology
2