510k
Database
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Anesthesiology
545
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1708
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380
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1352
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252
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981
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2215
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2068
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126
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100
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8
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474
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980
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441
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282
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3013
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52
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515
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2476
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155
Categories
LZA
Polymer Patient Examination Glove
416
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System, Image Processing,...
398
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Powered Laser Surgical Instrument
363
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Mask, Surgical
358
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Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
304
HRS
Plate, Fixation, Bone
290
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
233
MAX
Intervertebral Fusion Device...
228
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The Traumafuse Co.
Medical Device Manufacturer
·
US , Allentown , PA
The Traumafuse Co. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1989
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - The Traumafuse Co.
Anesthesiology
✕
2
devices
1-2 of 2
Filters
Cleared
Jan 09, 1990
TRAUMAFUSE TRACH SHIELD
K895162
·
BTO
Anesthesiology
·
140d
Cleared
Oct 13, 1989
CONNELL-STEPHENS ENDO ANESS TUBE
K895132
·
BTR
Anesthesiology
·
57d
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4
Cardiovascular
2
Anesthesiology
2