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963
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181
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1629
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114
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80
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405
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314
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2301
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1844
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Powered Laser Surgical Instrument
272
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256
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Automated Radiological Image...
241
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227
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System, Imaging, Pulsed Doppler,...
227
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Plate, Fixation, Bone
226
OLO
Orthopedic Stereotaxic Instrument
188
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Abutment, Implant, Dental,...
175
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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.
General & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
Nov 08, 1978
PREP TRAY, PREOPERATIVE SKIN
K781797
·
OJU
General & Plastic Surgery
·
16d
Cleared
Jun 22, 1978
IMPROVED DISPOSABLE HYPODERMIC NEEDLE
K780887
·
GAA
General & Plastic Surgery
·
27d
Cleared
Feb 25, 1977
MAJOR SUTURE REMOVAL TRAY
K770149
·
KDD
General & Plastic Surgery
·
32d
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24
General Hospital
9
Gastroenterology & Urology
5
Cardiovascular
3
General & Plastic Surgery
3
Hematology
2
Obstetrics & Gynecology
1
Anesthesiology
1