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3497
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475
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2514
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4254
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3896
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861
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1926
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757
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696
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609
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570
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Powered Laser Surgical Instrument
523
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Prosthesis, Knee,...
522
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Polymer Patient Examination Glove
489
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System, Nuclear Magnetic...
475
MAX
Intervertebral Fusion Device...
436
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Screw, Fixation, Bone
404
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Manufacturers
US
Biorem
Medical Device Manufacturer
·
US , Mchenry , IL
Biorem - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 1982
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Biorem
Gastroenterology & Urology
✕
2
devices
1-2 of 2
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Cleared
Feb 21, 1984
BIOREM 3000 & 4000
K833454
·
LIL
Gastroenterology & Urology
·
146d
Cleared
Aug 27, 1982
BIOREM 2000
K822099
·
LIL
Gastroenterology & Urology
·
42d
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Gastroenterology & Urology
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