510k
Database
Specialties
Anesthesiology
411
Cardiovascular
1252
Chemistry
309
Dental
950
Ear, Nose, Throat
181
Gastroenterology & Urology
739
General & Plastic Surgery
1606
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995
Hematology
113
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80
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6
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402
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695
Obstetrics & Gynecology
303
Ophthalmic
186
Orthopedic
2263
Pathology
43
Physical Medicine
378
Radiology
1825
Toxicology
138
Categories
GEX
Powered Laser Surgical Instrument
267
LLZ
System, Image Processing,...
255
QIH
Automated Radiological Image...
237
IYN
System, Imaging, Pulsed Doppler,...
225
GEI
Electrosurgical, Cutting &...
225
HRS
Plate, Fixation, Bone
223
OLO
Orthopedic Stereotaxic Instrument
186
NHA
Abutment, Implant, Dental,...
171
NKB
Thoracolumbosacral Pedicle Screw...
154
LZA
Polymer Patient Examination Glove
150
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Sintea Plustek
Medical Device Manufacturer
·
US , Fr. Myers , FL
Sintea Plustek - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2014
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sintea Plustek
Orthopedic
✕
1
devices
1-1 of 1
Filters
Cleared
Jul 24, 2014
PLIF LITE AND TLIF LITE
K132907
·
MAX
Orthopedic
·
310d
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