510k
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1033
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4328
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3210
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2787
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464
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2359
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3947
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3633
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786
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775
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15
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1404
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1755
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859
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492
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7536
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165
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961
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4605
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1237
Categories
LLZ
System, Image Processing,...
725
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Plate, Fixation, Bone
689
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Electrosurgical, Cutting &...
560
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System, Imaging, Pulsed Doppler,...
533
GEX
Powered Laser Surgical Instrument
519
LZA
Polymer Patient Examination Glove
489
JWH
Prosthesis, Knee,...
464
MAX
Intervertebral Fusion Device...
403
FXX
Mask, Surgical
400
HWC
Screw, Fixation, Bone
392
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Manufacturers
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Manufacturers
US
Wellcome Diagnostics
Medical Device Manufacturer
·
US , Walker , MI
Wellcome Diagnostics - FDA 510(k) Cleared Devices
28 submissions
·
28 cleared
·
Since 1983
28
Total
28
Cleared
0
Denied
28
devices
26-28 of 28
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1
2
Cleared
Jun 16, 1983
DAC-CEL PTH KIT RD51
K831069
·
CEW
Chemistry
·
73d
Cleared
Feb 18, 1983
DAC-CEL DIAGNATAL RD 50
K830203
·
JHI
Chemistry
·
29d
Cleared
Feb 18, 1983
DAC-CEL DIAGNATAL HCG STANDARDS RD49
K830204
·
JJX
Chemistry
·
29d
1
2
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28
Microbiology
12
Immunology
7
Chemistry
6
Hematology
3