510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1683
Chemistry
370
Dental
1341
Ear, Nose, Throat
250
Gastroenterology & Urology
978
General & Plastic Surgery
2199
General Hospital
2052
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126
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99
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8
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472
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967
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436
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279
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2952
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52
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515
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2455
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155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
391
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
281
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
228
MAX
Intervertebral Fusion Device...
220
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Speciality Fibres and Materials, Ltd.
Medical Device Manufacturer
·
GB , Coventry
Speciality Fibres and Materials, Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2019
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Speciality Fibres and Materials, Ltd.
General & Plastic Surgery
✕
2
devices
1-2 of 2
Filters
Cleared
Oct 21, 2024
Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag...
K222740
·
FRO
General & Plastic Surgery
·
773d
Cleared
Aug 15, 2019
Suprasorb A + Ag “R”
K183208
·
FRO
General & Plastic Surgery
·
269d
Filters
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2
General & Plastic Surgery
2