510k
Database
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Anesthesiology
674
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2075
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458
Dental
1681
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302
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1181
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2599
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2359
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142
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127
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12
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569
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1174
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532
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355
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3699
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57
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566
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2935
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166
Categories
LLZ
System, Image Processing,...
484
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Polymer Patient Examination Glove
444
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Powered Laser Surgical Instrument
426
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386
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Electrosurgical, Cutting &...
378
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System, Imaging, Pulsed Doppler,...
358
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Plate, Fixation, Bone
344
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Intervertebral Fusion Device...
294
QIH
Automated Radiological Image...
285
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Orthopedic Stereotaxic Instrument
280
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Manufacturers
NZ
Rhondium, Ltd.
Medical Device Manufacturer
·
NZ , Katikati
Rhondium, Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2015
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Rhondium, Ltd.
Dental
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 21, 2016
L- OVC
K162677
·
EIH
Dental
·
86d
Cleared
May 15, 2015
Rhondium One-Visit-Crown(OVC)
K143694
·
EBF
Dental
·
142d
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2
Dental
2