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1520
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5416
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4589
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3251
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540
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2869
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4726
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4194
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1088
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1351
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15
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2521
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2004
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1013
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557
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8471
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357
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1081
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5545
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1365
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LLZ
System, Image Processing,...
800
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Plate, Fixation, Bone
699
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Electrosurgical, Cutting &...
695
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System, Imaging, Pulsed Doppler,...
633
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Powered Laser Surgical Instrument
537
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Prosthesis, Knee,...
524
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System, Nuclear Magnetic...
499
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Polymer Patient Examination Glove
490
MAX
Intervertebral Fusion Device...
465
NKB
Thoracolumbosacral Pedicle Screw...
448
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Search FDA 510(k) devices
510k Database
Manufacturers
US
Medical, Inc.
Medical Device Manufacturer
·
US , Walker , MI
Medical, Inc. - FDA 510(k) Cleared Devices
21 submissions
·
20 cleared
·
Since 1977
21
Total
20
Cleared
0
Denied
FDA 510(k) Regulatory Record - Medical, Inc.
Anesthesiology
✕
4
devices
1-4 of 4
Filters
Cleared
Jun 22, 1993
ANESTHESIA RESPIRATORY BREATH CIRCUIT PACKS/COMPON
K926454
·
CAI
Anesthesiology
·
180d
Cleared
Oct 24, 1989
OS-1 OCCLUSION SYSTEM - 1
K894839
·
BZC
Anesthesiology
·
85d
Cleared
Jun 15, 1987
MODEL TPC-1A OXYGEN ANALYZER
K872001
·
CCL
Anesthesiology
·
20d
Cleared
Oct 15, 1986
MODEL A-1 OXYGEN ANALYZER
K863806
·
CCL
Anesthesiology
·
15d
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21
Cardiovascular
11
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4
Gastroenterology & Urology
3
General Hospital
3