510k
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Anesthesiology
1037
Cardiovascular
4331
Chemistry
3210
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2788
Ear, Nose, Throat
465
Gastroenterology & Urology
2369
General & Plastic Surgery
3973
General Hospital
3708
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788
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776
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15
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1404
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1755
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864
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492
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7536
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165
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962
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4605
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1237
Categories
LLZ
System, Image Processing,...
725
HRS
Plate, Fixation, Bone
689
GEI
Electrosurgical, Cutting &...
560
IYN
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
US
Telemed Div.
Medical Device Manufacturer
·
US , Hoffman Estates , IL
Telemed Div. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 1985
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Telemed Div.
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Aug 02, 1988
OMNIGRAPH 6000
K880357
·
DPS
Cardiovascular
·
187d
Cleared
Nov 19, 1985
OMNIGRAPH 4000(ELECTROCARDIOGRAPH)
K852652
·
DRS
Cardiovascular
·
151d
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Cardiovascular
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