510k
Database
Specialties
Anesthesiology
385
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1196
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293
Dental
889
Ear, Nose, Throat
164
Gastroenterology & Urology
703
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1517
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895
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108
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78
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1
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390
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659
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281
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173
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2189
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41
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355
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1745
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137
Categories
GEX
Powered Laser Surgical Instrument
253
QIH
Automated Radiological Image...
230
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System, Image Processing,...
226
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System, Imaging, Pulsed Doppler,...
221
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Plate, Fixation, Bone
217
GEI
Electrosurgical, Cutting &...
211
OLO
Orthopedic Stereotaxic Instrument
182
NHA
Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
148
MAX
Intervertebral Fusion Device...
146
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Mckesson Israel , Ltd.
Medical Device Manufacturer
·
IL , Tel Aviv
Mckesson Israel , Ltd. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2012
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Mckesson Israel , Ltd.
Cardiovascular
✕
3
devices
1-3 of 3
Filters
Cleared
Apr 18, 2014
MCKESSON CARDIOLOGY ECG MOBILE
K133534
·
DQK
Cardiovascular
·
151d
Cleared
Dec 05, 2013
MCKESSON CARDIOLOGY HEMO
K131497
·
MWI
Cardiovascular
·
195d
Cleared
Mar 16, 2012
HORIZON CARDIOLOGY ECG MANAGEMENT
K113515
·
DQK
Cardiovascular
·
109d
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5
Cardiovascular
3
Radiology
2