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
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471
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966
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436
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279
Orthopedic
2949
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52
Physical Medicine
515
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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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Argen Corporation
Medical Device Manufacturer
·
US , San Diego , CA
Argen Corporation - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2016
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Argen Corporation
Dental
✕
5
devices
1-5 of 5
Filters
Cleared
Oct 24, 2024
ArgenZ MTZ
K242458
·
EIH
Dental
·
66d
Cleared
Feb 10, 2020
Argen Clear Aligner, Argen Clear Aligner Premium
K192846
·
NXC
Dental
·
130d
Cleared
Jun 07, 2019
Argen Clear Aligner
K183229
·
NXC
Dental
·
199d
Cleared
May 18, 2018
ArgenIS Titanium Abutments
K172430
·
NHA
Dental
·
280d
Cleared
Aug 05, 2016
ArgenIS Titanium Abutments
K160248
·
NHA
Dental
·
186d
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5
Dental
5