510k
Database
Specialties
Anesthesiology
411
Cardiovascular
1252
Chemistry
309
Dental
950
Ear, Nose, Throat
181
Gastroenterology & Urology
739
General & Plastic Surgery
1606
General Hospital
995
Hematology
113
Immunology
80
Medical Genetics
6
Microbiology
402
Neurology
695
Obstetrics & Gynecology
303
Ophthalmic
186
Orthopedic
2263
Pathology
43
Physical Medicine
378
Radiology
1825
Toxicology
138
Categories
GEX
Powered Laser Surgical Instrument
267
LLZ
System, Image Processing,...
255
QIH
Automated Radiological Image...
237
GEI
Electrosurgical, Cutting &...
225
IYN
System, Imaging, Pulsed Doppler,...
225
HRS
Plate, Fixation, Bone
223
OLO
Orthopedic Stereotaxic Instrument
186
NHA
Abutment, Implant, Dental,...
171
NKB
Thoracolumbosacral Pedicle Screw...
154
LZA
Polymer Patient Examination Glove
150
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Cerner Corp.
Medical Device Manufacturer
·
US , Kansas City , MO
Cerner Corp. - FDA 510(k) Cleared Devices
7 submissions
·
7 cleared
·
Since 1996
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Cerner Corp.
Obstetrics & Gynecology
✕
2
devices
1-2 of 2
Filters
Cleared
Oct 09, 2012
CERNER FETALINK+(VERSION1.0)
K121758
·
HGM
Obstetrics & Gynecology
·
116d
Cleared
Aug 25, 2009
CERNER FETALINK (VERSION 1.0)
K091251
·
HGM
Obstetrics & Gynecology
·
118d
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7
Radiology
4
Obstetrics & Gynecology
2
Cardiovascular
1