510k
Database
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Anesthesiology
330
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1055
Chemistry
268
Dental
793
Ear, Nose, Throat
148
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619
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1307
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746
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97
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72
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1
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364
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566
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240
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154
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2032
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38
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309
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1570
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130
Categories
GEX
Powered Laser Surgical Instrument
227
HRS
Plate, Fixation, Bone
208
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System, Imaging, Pulsed Doppler,...
207
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Automated Radiological Image...
204
LLZ
System, Image Processing,...
197
GEI
Electrosurgical, Cutting &...
185
OLO
Orthopedic Stereotaxic Instrument
168
NHA
Abutment, Implant, Dental,...
153
MAX
Intervertebral Fusion Device...
137
NKB
Thoracolumbosacral Pedicle Screw...
133
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Transidyne General Corp.
Medical Device Manufacturer
·
US , Mchenry , IL
Transidyne General Corp. - FDA 510(k) Cleared Devices
21 submissions
·
15 cleared
·
Since 1978
21
Total
15
Cleared
0
Denied
FDA 510(k) Regulatory Record - Transidyne General Corp.
Anesthesiology
✕
2
devices
1-2 of 2
Filters
Cleared
Jun 16, 1993
TRACHEOSTOMY CARE KIT
K924243
·
JOH
Anesthesiology
·
296d
Cleared
Mar 30, 1990
MODEL 1050 - UMBILICAL CORD BLOOD SAMPLING KIT
K897133
·
CBT
Anesthesiology
·
93d
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21
General & Plastic Surgery
5
Chemistry
5
General Hospital
3
Obstetrics & Gynecology
3
Dental
2
Anesthesiology
2
Pathology
1