510k
Database
Specialties
Anesthesiology
527
Cardiovascular
1632
Chemistry
356
Dental
1304
Ear, Nose, Throat
239
Gastroenterology & Urology
946
General & Plastic Surgery
2156
General Hospital
2020
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126
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92
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8
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459
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948
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430
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272
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2770
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52
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515
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2356
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155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
374
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
297
QIH
Automated Radiological Image...
275
IYN
System, Imaging, Pulsed Doppler,...
271
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
220
NHA
Abutment, Implant, Dental,...
205
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Transtracheal Systems
Medical Device Manufacturer
·
US , Denver , CO
Transtracheal Systems - FDA 510(k) Cleared Devices
8 submissions
·
7 cleared
·
Since 1986
8
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Transtracheal Systems
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Mar 01, 1991
TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100
K904748
·
DRG
Cardiovascular
·
133d
Cleared
Mar 01, 1991
TRANSKINETICS RADO FREQ MULTI-LEAD TELE SYST 7200
K904749
·
DRQ
Cardiovascular
·
133d
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8
Anesthesiology
6
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2