510k
Database
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Anesthesiology
332
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1060
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268
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801
Ear, Nose, Throat
148
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621
General & Plastic Surgery
1318
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748
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97
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72
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1
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365
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573
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243
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155
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2045
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39
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309
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1580
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132
Categories
GEX
Powered Laser Surgical Instrument
227
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Plate, Fixation, Bone
209
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System, Imaging, Pulsed Doppler,...
208
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Automated Radiological Image...
205
LLZ
System, Image Processing,...
199
GEI
Electrosurgical, Cutting &...
185
OLO
Orthopedic Stereotaxic Instrument
168
NHA
Abutment, Implant, Dental,...
155
MAX
Intervertebral Fusion Device...
137
NKB
Thoracolumbosacral Pedicle Screw...
135
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Louisville Laboratories, Inc.
Medical Device Manufacturer
·
US , Weston , MA
Louisville Laboratories, Inc. - FDA 510(k) Cleared Devices
12 submissions
·
12 cleared
·
Since 1989
12
Total
12
Cleared
0
Denied
FDA 510(k) Regulatory Record - Louisville Laboratories, Inc.
General & Plastic Surgery
✕
2
devices
1-2 of 2
Filters
Cleared
Mar 09, 1998
CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET
K980123
·
GCJ
General & Plastic Surgery
·
54d
Cleared
Nov 02, 1993
EXTERNAL STABILITY PAD
K932979
·
GCJ
General & Plastic Surgery
·
138d
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3
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1