510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1683
Chemistry
369
Dental
1339
Ear, Nose, Throat
249
Gastroenterology & Urology
977
General & Plastic Surgery
2198
General Hospital
2048
Hematology
126
Immunology
99
Medical Genetics
8
Microbiology
469
Neurology
965
Obstetrics & Gynecology
436
Ophthalmic
279
Orthopedic
2944
Pathology
52
Physical Medicine
515
Radiology
2446
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 &...
306
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
279
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Shenzhen Rogin Medical Co., Ltd.
Medical Device Manufacturer
·
CN , Shenzhen
Shenzhen Rogin Medical Co., Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2025
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Shenzhen Rogin Medical Co., Ltd.
Dental
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 24, 2025
Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)
K242514
·
EKX
Dental
·
244d
Cleared
Mar 07, 2025
Apex Locator
K242383
·
LQY
Dental
·
207d
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2
Dental
2