510k
Database
Specialties
Anesthesiology
440
Cardiovascular
1343
Chemistry
331
Dental
1036
Ear, Nose, Throat
192
Gastroenterology & Urology
796
General & Plastic Surgery
1757
General Hospital
1168
Hematology
118
Immunology
84
Medical Genetics
7
Microbiology
414
Neurology
751
Obstetrics & Gynecology
331
Ophthalmic
205
Orthopedic
2401
Pathology
44
Physical Medicine
402
Radiology
1942
Toxicology
141
Categories
GEX
Powered Laser Surgical Instrument
287
LLZ
System, Image Processing,...
277
GEI
Electrosurgical, Cutting &...
249
QIH
Automated Radiological Image...
247
IYN
System, Imaging, Pulsed Doppler,...
237
HRS
Plate, Fixation, Bone
234
OLO
Orthopedic Stereotaxic Instrument
197
LZA
Polymer Patient Examination Glove
190
NHA
Abutment, Implant, Dental,...
184
MAX
Intervertebral Fusion Device...
165
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Kensey Nash Corp.
Medical Device Manufacturer
·
US , Exton , PA
Kensey Nash Corp. - FDA 510(k) Cleared Devices
19 submissions
·
19 cleared
·
Since 1993
19
Total
19
Cleared
0
Denied
FDA 510(k) Regulatory Record - Kensey Nash Corp.
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
Sep 21, 2007
MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE
K072384
·
MQV
Orthopedic
·
28d
Cleared
Jun 01, 2007
COPIOS BONE VOID FILLER SPONGE AND PASTE
K071237
·
MQV
Orthopedic
·
29d
Cleared
Sep 19, 2001
IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR
K011943
·
LZN
Orthopedic
·
90d
Filters
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All
19
General & Plastic Surgery
7
Cardiovascular
7
Orthopedic
3
Dental
2