510k
Database
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332
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1058
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268
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800
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148
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621
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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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2044
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39
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309
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1580
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132
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Powered Laser Surgical Instrument
227
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209
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System, Imaging, Pulsed Doppler,...
208
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Automated Radiological Image...
205
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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.
Obstetrics & Gynecology
✕
2
devices
1-2 of 2
Filters
Cleared
Jul 22, 1997
LAPAROSCOPIC BLADDER NECK SUSPENSION KIT
K971797
·
HET
Obstetrics & Gynecology
·
68d
Cleared
Apr 04, 1997
LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY
K963076
·
HET
Obstetrics & Gynecology
·
240d
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12
Orthopedic
3
Anesthesiology
2
General & Plastic Surgery
2
Obstetrics & Gynecology
2
Gastroenterology & Urology
2
General Hospital
1