510k
Database
Specialties
Anesthesiology
1092
Cardiovascular
4434
Chemistry
3258
Dental
2793
Ear, Nose, Throat
468
Gastroenterology & Urology
2428
General & Plastic Surgery
4114
General Hospital
3832
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805
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782
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15
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1726
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1772
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883
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497
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7544
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166
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963
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4782
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1239
Categories
LLZ
System, Image Processing,...
730
HRS
Plate, Fixation, Bone
689
GEI
Electrosurgical, Cutting &...
568
IYN
System, Imaging, Pulsed Doppler,...
535
GEX
Powered Laser Surgical Instrument
520
LZA
Polymer Patient Examination Glove
489
JWH
Prosthesis, Knee,...
464
LNH
System, Nuclear Magnetic...
431
MAX
Intervertebral Fusion Device...
403
FXX
Mask, Surgical
400
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Manufacturers
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Manufacturers
US
Mediflex Intl.
Medical Device Manufacturer
·
US , Mchenry , IL
Mediflex Intl. - FDA 510(k) Cleared Devices
9 submissions
·
8 cleared
·
Since 1984
9
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Mediflex Intl.
General Hospital
✕
4
devices
1-4 of 4
Filters
Cleared
Feb 11, 1992
PRIMARY DRESSING TRAY
K915140
·
LYY
General Hospital
·
90d
Cleared
May 24, 1989
MEDIVERSE PARENTERAL NUTRITION BAG
K891077
·
KPE
General Hospital
·
84d
Cleared
Nov 18, 1985
MEDIFLEX DISPOSABLE TUBING CLAMP
K854346
·
FPA
General Hospital
·
20d
Cleared
Jun 07, 1985
I.V. ADMINISTRATION SET
K852106
·
FPA
General Hospital
·
23d
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9
General Hospital
4
Gastroenterology & Urology
4
General & Plastic Surgery
1