510k
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Anesthesiology
362
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1151
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284
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860
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153
Gastroenterology & Urology
671
General & Plastic Surgery
1431
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844
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107
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76
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1
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379
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632
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261
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166
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2148
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40
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343
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1681
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133
Categories
GEX
Powered Laser Surgical Instrument
244
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Automated Radiological Image...
221
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System, Imaging, Pulsed Doppler,...
216
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Plate, Fixation, Bone
216
LLZ
System, Image Processing,...
213
GEI
Electrosurgical, Cutting &...
198
OLO
Orthopedic Stereotaxic Instrument
179
NHA
Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
147
MAX
Intervertebral Fusion Device...
146
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Howmedica Osteonics Corp.
Medical Device Manufacturer
·
US , Allendale , NJ
Howmedica Osteonics Corp. - FDA 510(k) Cleared Devices
288 submissions
·
288 cleared
·
Since 1999
288
Total
288
Cleared
0
Denied
FDA 510(k) Regulatory Record - Howmedica Osteonics Corp.
General & Plastic Surgery
✕
2
devices
1-2 of 2
Filters
Cleared
Nov 01, 2012
STRYKER CMF MEDPOR CUSTOMIZED IMPLANT
K121315
·
FWP
General & Plastic Surgery
·
183d
Cleared
Jun 25, 2010
STRYKER KNIFELIGHT
K100884
·
FTD
General & Plastic Surgery
·
87d
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288
Orthopedic
285
General & Plastic Surgery
2
Neurology
1