510k
Database
Specialties
Anesthesiology
134
Cardiovascular
569
Chemistry
164
Dental
315
Ear, Nose, Throat
68
Gastroenterology & Urology
289
General & Plastic Surgery
521
General Hospital
373
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
233
Neurology
168
Obstetrics & Gynecology
61
Ophthalmic
49
Orthopedic
1294
Pathology
18
Physical Medicine
86
Radiology
870
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
MBI
Fastener, Fixation,...
85
NHA
Abutment, Implant, Dental,...
85
MAX
Intervertebral Fusion Device...
83
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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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) cleared devices by 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