510k
Database
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Anesthesiology
430
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1306
Chemistry
327
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1004
Ear, Nose, Throat
190
Gastroenterology & Urology
782
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1697
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1102
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117
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83
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7
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412
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733
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321
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199
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2365
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44
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393
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1898
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141
Categories
GEX
Powered Laser Surgical Instrument
281
LLZ
System, Image Processing,...
267
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Automated Radiological Image...
246
GEI
Electrosurgical, Cutting &...
239
IYN
System, Imaging, Pulsed Doppler,...
232
HRS
Plate, Fixation, Bone
231
OLO
Orthopedic Stereotaxic Instrument
194
NHA
Abutment, Implant, Dental,...
180
LZA
Polymer Patient Examination Glove
170
NKB
Thoracolumbosacral Pedicle Screw...
161
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Dymax Corp
Medical Device Manufacturer
·
US , Pittsburgh , PA
Dymax Corp - FDA 510(k) Cleared Devices
7 submissions
·
7 cleared
·
Since 1985
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Dymax Corp
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Jul 27, 1993
SITERITE NEEDLE GUIDE (MODIFIED)
K931403
·
DQY
Cardiovascular
·
130d
Cleared
Sep 27, 1990
SITERITE NEEDLE GUIDE
K903158
·
DQY
Cardiovascular
·
71d
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7
Radiology
4
Cardiovascular
2
Obstetrics & Gynecology
1