510k
Database
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Anesthesiology
527
Cardiovascular
1633
Chemistry
356
Dental
1304
Ear, Nose, Throat
239
Gastroenterology & Urology
946
General & Plastic Surgery
2157
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2020
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126
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92
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8
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459
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948
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430
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272
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2780
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52
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515
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2364
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155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
376
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
297
QIH
Automated Radiological Image...
275
IYN
System, Imaging, Pulsed Doppler,...
272
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
220
NHA
Abutment, Implant, Dental,...
205
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Genzyme Surgical Product (Genzyme Biosurgery)
Medical Device Manufacturer
·
US , Fall River , MA
Genzyme Surgical Product (Genzyme Biosurgery) - FDA 510(k) Cleared De...
9 submissions
·
8 cleared
·
Since 1998
9
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Genzyme Surgical Product (Genzyme Biosurgery)
Cardiovascular
✕
1
devices
1-1 of 1
Filters
Cleared
Aug 07, 1998
MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE
K980016
·
MOP
Cardiovascular
·
217d
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9
General & Plastic Surgery
7
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1
Anesthesiology
1