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2217
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2784
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593
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3872
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606
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3108
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527
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Polymer Patient Examination Glove
458
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444
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402
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Mask, Surgical
388
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System, Imaging, Pulsed Doppler,...
372
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Plate, Fixation, Bone
359
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Intervertebral Fusion Device...
314
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Orthopedic Stereotaxic Instrument
288
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Automated Radiological Image...
286
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Manufacturers
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Coloplast A/S
Medical Device Manufacturer
·
US , Mchenry , IL
Coloplast A/S - FDA 510(k) Cleared Devices
71 submissions
·
68 cleared
·
Since 1983
Official Website
71
Total
68
Cleared
0
Denied
FDA 510(k) Regulatory Record - Coloplast A/S
General Hospital
✕
1
devices
1-1 of 1
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Cleared
Aug 17, 2011
VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT
K111881
·
OTM
General Hospital
·
47d
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71
Gastroenterology & Urology
45
General & Plastic Surgery
19
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6
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