510k
Database
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Anesthesiology
550
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1723
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386
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1385
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256
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990
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2226
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2093
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127
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104
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8
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474
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985
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443
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285
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3058
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52
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515
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2503
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156
Categories
LZA
Polymer Patient Examination Glove
418
LLZ
System, Image Processing,...
401
GEX
Powered Laser Surgical Instrument
363
FXX
Mask, Surgical
359
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Electrosurgical, Cutting &...
310
IYN
System, Imaging, Pulsed Doppler,...
304
HRS
Plate, Fixation, Bone
298
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
236
MAX
Intervertebral Fusion Device...
233
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Meditech Gloves Sdn Bhd
Medical Device Manufacturer
·
MY , Nilai
Meditech Gloves Sdn Bhd - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2021
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Meditech Gloves Sdn Bhd
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 17, 2022
BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free
K213408
·
LZA
General Hospital
·
180d
Cleared
May 07, 2021
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)
K210755
·
LZA
General Hospital
·
53d
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General Hospital
2