510k
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1266
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311
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963
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181
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752
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1629
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1023
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114
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80
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405
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704
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314
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190
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2301
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43
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379
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1844
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138
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GEX
Powered Laser Surgical Instrument
272
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System, Image Processing,...
256
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Automated Radiological Image...
241
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System, Imaging, Pulsed Doppler,...
227
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Electrosurgical, Cutting &...
227
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Plate, Fixation, Bone
226
OLO
Orthopedic Stereotaxic Instrument
188
NHA
Abutment, Implant, Dental,...
175
NKB
Thoracolumbosacral Pedicle Screw...
155
LZA
Polymer Patient Examination Glove
154
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Pharmaseal Div., Baxter Healthcare Corp.
Medical Device Manufacturer
·
US , Mchenry , IL
Pharmaseal Div., Baxter Healthcare Corp. - FDA 510(k) Cleared Devices
24 submissions
·
24 cleared
·
Since 1976
24
Total
24
Cleared
0
Denied
FDA 510(k) Regulatory Record - Pharmaseal Div., Baxter Healthcare Corp.
Cardiovascular
✕
3
devices
1-3 of 3
Filters
Cleared
Dec 05, 1979
CONTINUOUS FLUSH DEVICE
K792141
·
KRA
Cardiovascular
·
44d
Cleared
Oct 06, 1978
MONITORING, PRESSURE KIT
K781680
·
DRS
Cardiovascular
·
4d
Cleared
Nov 17, 1977
PRESSURE TUBING
K771810
·
DQO
Cardiovascular
·
51d
Filters
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24
General Hospital
9
Gastroenterology & Urology
5
General & Plastic Surgery
3
Cardiovascular
3
Hematology
2
Anesthesiology
1
Obstetrics & Gynecology
1