510k
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540
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1660
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362
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1333
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244
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958
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2183
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2039
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126
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97
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8
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466
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962
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433
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274
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2868
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52
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515
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2428
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155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
383
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Mask, Surgical
358
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
219
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Roncadelle Operations Srl
Medical Device Manufacturer
·
IT , Castel Mella (Brescia)
Roncadelle Operations Srl - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2022
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Roncadelle Operations Srl
General Hospital
✕
1
devices
1-1 of 1
Filters
Cleared
Dec 29, 2022
SafeR Syringe and SafeR Sting
K221981
·
MEG
General Hospital
·
177d
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1
General Hospital
1