510k
Database
Specialties
Anesthesiology
429
Cardiovascular
1299
Chemistry
327
Dental
1001
Ear, Nose, Throat
187
Gastroenterology & Urology
773
General & Plastic Surgery
1688
General Hospital
1094
Hematology
117
Immunology
83
Medical Genetics
7
Microbiology
411
Neurology
730
Obstetrics & Gynecology
318
Ophthalmic
198
Orthopedic
2356
Pathology
44
Physical Medicine
393
Radiology
1888
Toxicology
140
Categories
GEX
Powered Laser Surgical Instrument
279
LLZ
System, Image Processing,...
266
QIH
Automated Radiological Image...
246
GEI
Electrosurgical, Cutting &...
238
HRS
Plate, Fixation, Bone
231
IYN
System, Imaging, Pulsed Doppler,...
231
OLO
Orthopedic Stereotaxic Instrument
193
NHA
Abutment, Implant, Dental,...
180
LZA
Polymer Patient Examination Glove
170
NKB
Thoracolumbosacral Pedicle Screw...
161
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Etex Corp.
Medical Device Manufacturer
·
US , Cambridge , MA
Etex Corp. - FDA 510(k) Cleared Devices
18 submissions
·
17 cleared
·
Since 1994
18
Total
17
Cleared
0
Denied
FDA 510(k) Regulatory Record - Etex Corp.
Dental
✕
3
devices
1-3 of 3
Filters
Cleared
Dec 21, 2010
CARRIGEN
K100883
·
LYC
Dental
·
266d
Cleared
Dec 23, 2009
ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE
K091729
·
LYC
Dental
·
195d
Cleared
Aug 05, 1997
BSM BONE SUBSTITUTE MATERIAL KIT
K962548
·
LYC
Dental
·
403d
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18
Orthopedic
13
Dental
3
Neurology
2