510k
Database
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Anesthesiology
435
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1325
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327
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1018
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192
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787
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1729
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1127
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117
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83
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7
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413
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740
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326
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201
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2381
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44
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396
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1922
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141
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Powered Laser Surgical Instrument
284
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System, Image Processing,...
272
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Automated Radiological Image...
247
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Electrosurgical, Cutting &...
243
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System, Imaging, Pulsed Doppler,...
235
HRS
Plate, Fixation, Bone
232
OLO
Orthopedic Stereotaxic Instrument
195
NHA
Abutment, Implant, Dental,...
182
LZA
Polymer Patient Examination Glove
176
MAX
Intervertebral Fusion Device...
165
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Imagyn Medical Technologies, Inc.
Medical Device Manufacturer
·
US , Richland , MI
Imagyn Medical Technologies, Inc. - FDA 510(k) Cleared Devices
7 submissions
·
6 cleared
·
Since 1998
7
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Imagyn Medical Technologies, Inc.
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 03, 2001
IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM
K010166
·
IWJ
Radiology
·
319d
Cleared
Jun 17, 1999
ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501
K991526
·
KXK
Radiology
·
45d
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7
Radiology
2
Gastroenterology & Urology
2
Anesthesiology
1
Obstetrics & Gynecology
1
Cardiovascular
1