510k
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1054
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194
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1777
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121
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84
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408
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1972
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Powered Laser Surgical Instrument
290
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281
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Automated Radiological Image...
251
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251
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System, Imaging, Pulsed Doppler,...
240
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Plate, Fixation, Bone
235
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Polymer Patient Examination Glove
204
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Orthopedic Stereotaxic Instrument
198
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Abutment, Implant, Dental,...
187
MAX
Intervertebral Fusion Device...
167
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Ugm Medical Systems, Inc.
Medical Device Manufacturer
·
US , Wayne , PA
Ugm Medical Systems, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1989
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ugm Medical Systems, Inc.
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Jan 21, 1998
QUEST PET IMAGING SYSTEM
K973396
·
KPS
Radiology
·
149d
Cleared
Apr 07, 1995
PENN-PET SCANNER
K945721
·
KPS
Radiology
·
137d
Cleared
Jun 08, 1993
PENN-PET SCANNER
K930428
·
KPS
Radiology
·
133d
Cleared
Apr 13, 1989
PENN-PET SCANNER
K890100
·
KPS
Radiology
·
93d
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4
Radiology
4