510k
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473
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334
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209
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836
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1876
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125
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87
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355
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2468
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48
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429
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2051
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145
Categories
GEX
Powered Laser Surgical Instrument
305
LLZ
System, Image Processing,...
304
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Polymer Patient Examination Glove
260
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Electrosurgical, Cutting &...
259
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Automated Radiological Image...
255
IYN
System, Imaging, Pulsed Doppler,...
245
HRS
Plate, Fixation, Bone
243
OLO
Orthopedic Stereotaxic Instrument
203
NHA
Abutment, Implant, Dental,...
190
MAX
Intervertebral Fusion Device...
171
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Groupe Lepine
Medical Device Manufacturer
·
US , Sarasota , FL
Groupe Lepine - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 1999
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Groupe Lepine
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Jan 10, 2000
EIS DYNAMIC MEMORY STAPLES SYSTEM
K991962
·
JDR
Orthopedic
·
214d
Cleared
Dec 20, 1999
EIS THREADED SCREW FRACTURE FIXATION
K991964
·
HWC
Orthopedic
·
193d
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Orthopedic
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