510k
Database
Specialties
Anesthesiology
134
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569
Chemistry
164
Dental
314
Ear, Nose, Throat
68
Gastroenterology & Urology
289
General & Plastic Surgery
521
General Hospital
373
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
233
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168
Obstetrics & Gynecology
61
Ophthalmic
49
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1294
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18
Physical Medicine
86
Radiology
870
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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,...
84
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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Zeus Scientific
Medical Device Manufacturer
·
US , Branchburg , NJ
Zeus Scientific - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2023
5
Total
5
Cleared
0
Denied
FDA 510(k) cleared devices by Zeus Scientific
Immunology
✕
4
devices
1-4 of 4
Filters
Cleared
Oct 22, 2025
Alegria Flash CTD Screen
K250666
·
LLL
Immunology
·
231d
Cleared
Sep 19, 2025
Alegria Flash ENA Screen
K250408
·
LLL
Immunology
·
218d
Cleared
May 07, 2025
Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed)
K243776
·
MOB
Immunology
·
149d
Cleared
Aug 31, 2023
ZEUS IFA(TM) nDNA Test System, ZEUS dIFine
K231616
·
KTL
Immunology
·
90d
Filters
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5
Immunology
4
Microbiology
1