510k
Database
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Anesthesiology
445
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1357
Chemistry
333
Dental
1051
Ear, Nose, Throat
194
Gastroenterology & Urology
805
General & Plastic Surgery
1771
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1195
Hematology
120
Immunology
84
Medical Genetics
7
Microbiology
419
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760
Obstetrics & Gynecology
333
Ophthalmic
209
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2417
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44
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405
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1964
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142
Categories
GEX
Powered Laser Surgical Instrument
288
LLZ
System, Image Processing,...
280
GEI
Electrosurgical, Cutting &...
251
QIH
Automated Radiological Image...
250
IYN
System, Imaging, Pulsed Doppler,...
239
HRS
Plate, Fixation, Bone
235
LZA
Polymer Patient Examination Glove
200
OLO
Orthopedic Stereotaxic Instrument
198
NHA
Abutment, Implant, Dental,...
187
NKB
Thoracolumbosacral Pedicle Screw...
167
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Kensey Nash Corporation
Medical Device Manufacturer
·
US , Exton , PA
Kensey Nash Corporation - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 2006
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Kensey Nash Corporation
General & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
Feb 10, 2012
MESO WOUND MATRIX
K112888
·
KGN
General & Plastic Surgery
·
133d
Cleared
May 18, 2010
KENSEY NASH ECM SURGICAL PATCH
K094061
·
FTM
General & Plastic Surgery
·
138d
Cleared
May 09, 2006
BIOBLANKET SURGICAL MESH
K061030
·
FTM
General & Plastic Surgery
·
25d
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6
General & Plastic Surgery
3
Cardiovascular
1
Orthopedic
1
Dental
1