510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1680
Chemistry
365
Dental
1337
Ear, Nose, Throat
248
Gastroenterology & Urology
972
General & Plastic Surgery
2194
General Hospital
2047
Hematology
126
Immunology
99
Medical Genetics
8
Microbiology
469
Neurology
965
Obstetrics & Gynecology
433
Ophthalmic
275
Orthopedic
2923
Pathology
52
Physical Medicine
515
Radiology
2442
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
388
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
305
IYN
System, Imaging, Pulsed Doppler,...
299
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
275
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Smith and Nephew, Inc.
Medical Device Manufacturer
·
US , Andover , MA
Smith and Nephew, Inc. - FDA 510(k) Cleared Devices
7 submissions
·
7 cleared
·
Since 2016
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Smith and Nephew, Inc.
General & Plastic Surgery
✕
2
devices
1-2 of 2
Filters
Cleared
Oct 20, 2022
SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447),...
K221740
·
GCJ
General & Plastic Surgery
·
127d
Cleared
Aug 23, 2019
LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi,...
K191177
·
GCJ
General & Plastic Surgery
·
113d
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7
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5
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