510k
Database
Specialties
Anesthesiology
538
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1656
Chemistry
360
Dental
1323
Ear, Nose, Throat
243
Gastroenterology & Urology
957
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2176
General Hospital
2038
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126
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97
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8
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462
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959
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433
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274
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2838
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52
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515
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2413
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
382
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
213
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Megine Industries Sdn Bhd
Medical Device Manufacturer
·
MY , Kuala Lumpur
Megine Industries Sdn Bhd - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2021
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Megine Industries Sdn Bhd
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Feb 20, 2022
Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange
K220232
·
LZA
General Hospital
·
24d
Cleared
Jun 16, 2021
AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black,...
K211310
·
LZA
General Hospital
·
47d
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General Hospital
2