510k
Database
Specialties
Anesthesiology
444
Cardiovascular
1348
Chemistry
331
Dental
1048
Ear, Nose, Throat
193
Gastroenterology & Urology
803
General & Plastic Surgery
1767
General Hospital
1188
Hematology
120
Immunology
84
Medical Genetics
7
Microbiology
418
Neurology
759
Obstetrics & Gynecology
332
Ophthalmic
208
Orthopedic
2413
Pathology
44
Physical Medicine
405
Radiology
1953
Toxicology
142
Categories
GEX
Powered Laser Surgical Instrument
287
LLZ
System, Image Processing,...
278
GEI
Electrosurgical, Cutting &...
250
QIH
Automated Radiological Image...
248
IYN
System, Imaging, Pulsed Doppler,...
238
HRS
Plate, Fixation, Bone
235
LZA
Polymer Patient Examination Glove
199
OLO
Orthopedic Stereotaxic Instrument
198
NHA
Abutment, Implant, Dental,...
187
MAX
Intervertebral Fusion Device...
167
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Elekta Instruments, Inc.
Medical Device Manufacturer
·
US , Tucker , GA
Elekta Instruments, Inc. - FDA 510(k) Cleared Devices
8 submissions
·
8 cleared
·
Since 1992
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Elekta Instruments, Inc.
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
May 23, 1995
CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRACTURE FIXATION (OSTEOSYNTHESIS) SYSTEM
K946165
·
HRS
Orthopedic
·
155d
Cleared
Jan 07, 1994
ES-100 ACCESSORIES
K932261
·
HWE
Orthopedic
·
262d
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8
Neurology
3
Orthopedic
2
Radiology
2
General & Plastic Surgery
1