510k
Database
Specialties
Anesthesiology
478
Cardiovascular
1444
Chemistry
337
Dental
1139
Ear, Nose, Throat
210
Gastroenterology & Urology
841
General & Plastic Surgery
1895
General Hospital
1440
Hematology
125
Immunology
89
Medical Genetics
8
Microbiology
426
Neurology
812
Obstetrics & Gynecology
362
Ophthalmic
238
Orthopedic
2484
Pathology
49
Physical Medicine
439
Radiology
2062
Toxicology
145
Categories
GEX
Powered Laser Surgical Instrument
307
LLZ
System, Image Processing,...
305
LZA
Polymer Patient Examination Glove
278
GEI
Electrosurgical, Cutting &...
261
QIH
Automated Radiological Image...
256
IYN
System, Imaging, Pulsed Doppler,...
246
HRS
Plate, Fixation, Bone
245
OLO
Orthopedic Stereotaxic Instrument
204
NHA
Abutment, Implant, Dental,...
191
MAX
Intervertebral Fusion Device...
172
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Kontron Instruments, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Kontron Instruments, Inc. - FDA 510(k) Cleared Devices
57 submissions
·
57 cleared
·
Since 1981
57
Total
57
Cleared
0
Denied
FDA 510(k) Regulatory Record - Kontron Instruments, Inc.
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Feb 27, 1987
KONTRON SIGMA 1SC DIGITAL ECHOCARDIOGRAPHY SYSTEM
K862686
·
ITX
Radiology
·
227d
Cleared
Feb 17, 1984
SIGMA 20 ELECTRONIC SECTOR SCANNER
K833680
·
IYO
Radiology
·
119d
Cleared
Nov 24, 1981
ZIKON 100 DIGITAL X-RAY SYSTEM
K813032
·
JAB
Radiology
·
27d
Cleared
Aug 07, 1981
MS-50 ULTRASONIC IMAGER
K811252
·
IYO
Radiology
·
94d
Filters
Filter by Specialty
All
57
Cardiovascular
37
Anesthesiology
7
Obstetrics & Gynecology
5
Radiology
4
Neurology
2
Gastroenterology & Urology
1
General Hospital
1