510k
Database
Specialties
Anesthesiology
545
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1703
Chemistry
377
Dental
1351
Ear, Nose, Throat
250
Gastroenterology & Urology
981
General & Plastic Surgery
2215
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2065
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126
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100
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8
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474
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980
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439
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282
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2992
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52
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515
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2474
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155
Categories
LZA
Polymer Patient Examination Glove
415
LLZ
System, Image Processing,...
398
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Powered Laser Surgical Instrument
363
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Mask, Surgical
358
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Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
303
HRS
Plate, Fixation, Bone
286
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
225
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Suturion AB
Medical Device Manufacturer
·
SE , Lund
Suturion AB - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2025
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Suturion AB
General & Plastic Surgery
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 28, 2025
Suture-TOOL System
K250977
·
NEW
General & Plastic Surgery
·
28d
Cleared
Jan 22, 2025
Suture-TOOL System
K242835
·
NEW
General & Plastic Surgery
·
125d
Filters
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2
General & Plastic Surgery
2