510k
Database
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Anesthesiology
426
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1286
Chemistry
322
Dental
982
Ear, Nose, Throat
184
Gastroenterology & Urology
757
General & Plastic Surgery
1657
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1065
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116
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82
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6
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408
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724
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316
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194
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2332
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44
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390
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1873
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139
Categories
GEX
Powered Laser Surgical Instrument
278
LLZ
System, Image Processing,...
262
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Automated Radiological Image...
244
IYN
System, Imaging, Pulsed Doppler,...
230
HRS
Plate, Fixation, Bone
229
GEI
Electrosurgical, Cutting &...
229
OLO
Orthopedic Stereotaxic Instrument
191
NHA
Abutment, Implant, Dental,...
177
LZA
Polymer Patient Examination Glove
163
NKB
Thoracolumbosacral Pedicle Screw...
159
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Paradigm Medical Industries, Inc.
Medical Device Manufacturer
·
US , Salt Lake City , UT
Paradigm Medical Industries, Inc. - FDA 510(k) Cleared Devices
10 submissions
·
10 cleared
·
Since 1995
10
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Paradigm Medical Industries, Inc.
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
May 26, 2005
ULTRASONIC BIO-MICROSCOPE, MODEL P60
K050980
·
IYO
Radiology
·
37d
Cleared
Dec 05, 2000
UBM PLUS, MODEL P45
K003141
·
IYO
Radiology
·
56d
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10
Ophthalmic
6
General & Plastic Surgery
2
Radiology
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