510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1683
Chemistry
370
Dental
1341
Ear, Nose, Throat
250
Gastroenterology & Urology
978
General & Plastic Surgery
2199
General Hospital
2050
Hematology
126
Immunology
99
Medical Genetics
8
Microbiology
471
Neurology
966
Obstetrics & Gynecology
436
Ophthalmic
279
Orthopedic
2949
Pathology
52
Physical Medicine
515
Radiology
2454
Toxicology
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
280
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Sdi Limited
Medical Device Manufacturer
·
AU , Bayswater
Sdi Limited - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 2010
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sdi Limited
Dental
✕
6
devices
1-6 of 6
Filters
Cleared
Oct 28, 2022
Stela Automix System
K222581
·
EBF
Dental
·
63d
Cleared
Oct 28, 2022
Stela Capsule System
K222583
·
EBF
Dental
·
63d
Cleared
Aug 30, 2022
Riva Cem Automix
K214118
·
EMA
Dental
·
243d
Cleared
Dec 02, 2019
Zipbond
K191656
·
KLE
Dental
·
164d
Cleared
Apr 11, 2018
Riva Star
K172047
·
PHR
Dental
·
279d
Cleared
Dec 08, 2010
AURA
K102984
·
EBF
Dental
·
62d
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6
Dental
6