510k
Database
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Anesthesiology
1092
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4436
Chemistry
3278
Dental
2794
Ear, Nose, Throat
468
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2431
General & Plastic Surgery
4114
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3832
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805
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785
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15
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1730
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1772
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883
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497
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7695
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167
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963
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4789
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1239
Categories
LLZ
System, Image Processing,...
730
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Plate, Fixation, Bone
690
GEI
Electrosurgical, Cutting &...
568
IYN
System, Imaging, Pulsed Doppler,...
535
GEX
Powered Laser Surgical Instrument
520
JWH
Prosthesis, Knee,...
493
LZA
Polymer Patient Examination Glove
489
LNH
System, Nuclear Magnetic...
431
MAX
Intervertebral Fusion Device...
406
FXX
Mask, Surgical
400
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Manufacturers
US
Medi-Spec
Medical Device Manufacturer
·
US , Mchenry , IL
Medi-Spec - FDA 510(k) Cleared Devices
8 submissions
·
8 cleared
·
Since 1978
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Medi-Spec
General & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 26, 1981
WHISK-R
K812694
·
GEE
General & Plastic Surgery
·
34d
Cleared
Apr 24, 1980
MEDSPEC OPERATIVE OPTHALMIC KIT
K800404
·
HMP
General & Plastic Surgery
·
58d
Cleared
Jun 05, 1979
CLAMP COVERS
K790952
·
GAD
General & Plastic Surgery
·
14d
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8
General & Plastic Surgery
3
General Hospital
2
Obstetrics & Gynecology
2
Ophthalmic
1