510k
Database
Specialties
Anesthesiology
208
Cardiovascular
743
Chemistry
187
Dental
473
Ear, Nose, Throat
92
Gastroenterology & Urology
398
General & Plastic Surgery
784
General Hospital
482
Hematology
77
Immunology
64
Medical Genetics
1
Microbiology
278
Neurology
310
Obstetrics & Gynecology
121
Ophthalmic
81
Orthopedic
1484
Pathology
26
Physical Medicine
155
Radiology
1105
Toxicology
95
Categories
IYN
System, Imaging, Pulsed Doppler,...
168
HRS
Plate, Fixation, Bone
151
OLO
Orthopedic Stereotaxic Instrument
131
GEX
Powered Laser Surgical Instrument
128
LLZ
System, Image Processing,...
126
QIH
Automated Radiological Image...
114
GEI
Electrosurgical, Cutting &...
105
NHA
Abutment, Implant, Dental,...
105
MAX
Intervertebral Fusion Device...
98
MBI
Fastener, Fixation,...
93
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K2m
Medical Device Manufacturer
·
US , Leesburg , VA
K2m - FDA 510(k) Cleared Devices
16 submissions
·
16 cleared
·
Since 2014
16
Total
16
Cleared
0
Denied
FDA 510(k) cleared devices by K2m
Gastroenterology & Urology
✕
1
devices
1-1 of 1
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Cleared
Jan 05, 2016
K2M Fenestrated Tap System
K152872
·
KNW
Gastroenterology & Urology
·
97d
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16
Orthopedic
15
Gastroenterology & Urology
1