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974
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3809
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2063
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2258
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454
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2200
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3649
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3449
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503
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566
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15
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1200
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486
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6923
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82
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700
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4159
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937
Categories
LLZ
System, Image Processing,...
705
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Plate, Fixation, Bone
653
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Electrosurgical, Cutting &...
524
GEX
Powered Laser Surgical Instrument
519
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System, Imaging, Pulsed Doppler,...
502
LZA
Polymer Patient Examination Glove
483
MAX
Intervertebral Fusion Device...
403
JWH
Prosthesis, Knee,...
401
FXX
Mask, Surgical
398
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Screw, Fixation, Bone
378
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Manufacturers
MY
Smart Glove Corp. Sdn Bhd
Medical Device Manufacturer
·
MY , Klang Selangor
Smart Glove Corp. Sdn Bhd - FDA 510(k) Cleared Devices
27 submissions
·
27 cleared
·
Since 1998
27
Total
27
Cleared
0
Denied
27
devices
26-27 of 27
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1
2
Cleared
Mar 13, 1998
LATEX EXAMINATION GLOVE POWDER FREE
K974870
·
LYY
General Hospital
·
74d
Cleared
Mar 13, 1998
NITRILE PRE-POWDERED EXAMINATION GLOVES
K974907
·
LZA
General Hospital
·
72d
1
2
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27
General Hospital
27