510k
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234
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Polymer Patient Examination Glove
393
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361
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348
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310
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Electrosurgical, Cutting &...
292
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Automated Radiological Image...
272
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System, Imaging, Pulsed Doppler,...
264
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Plate, Fixation, Bone
261
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Orthopedic Stereotaxic Instrument
217
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Abutment, Implant, Dental,...
204
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Flaem Nuova S.P.A.
Medical Device Manufacturer
·
US , North Reading , MA
Flaem Nuova S.P.A. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2007
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Flaem Nuova S.P.A.
Anesthesiology
✕
2
devices
1-2 of 2
Filters
Cleared
Jun 08, 2007
FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS
K062484
·
CAF
Anesthesiology
·
287d
Cleared
Mar 22, 2007
FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND...
K062014
·
CAF
Anesthesiology
·
248d
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2
Anesthesiology
2