510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1666
Chemistry
362
Dental
1334
Ear, Nose, Throat
245
Gastroenterology & Urology
963
General & Plastic Surgery
2186
General Hospital
2043
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126
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97
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8
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466
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965
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433
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274
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2886
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52
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515
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2431
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
384
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
353
GEI
Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
270
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
219
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Bomtech Electronics Co., Ltd.
Medical Device Manufacturer
·
KR , Seoul
Bomtech Electronics Co., Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2024
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bomtech Electronics Co., Ltd.
General & Plastic Surgery
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 07, 2025
E-PEN (E-PEN)
K243143
·
QAI
General & Plastic Surgery
·
189d
Cleared
Dec 26, 2024
RM STAR EX with RMS Needle
K243097
·
GEI
General & Plastic Surgery
·
87d
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2
General & Plastic Surgery
2