510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1660
Chemistry
362
Dental
1324
Ear, Nose, Throat
244
Gastroenterology & Urology
957
General & Plastic Surgery
2182
General Hospital
2039
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
464
Neurology
961
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2861
Pathology
52
Physical Medicine
515
Radiology
2417
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
382
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
288
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
219
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Datex Division Instrumentarium Corp.
Medical Device Manufacturer
·
US , Walker , MI
Datex Division Instrumentarium Corp. - FDA 510(k) Cleared Devices
55 submissions
·
55 cleared
·
Since 1982
55
Total
55
Cleared
0
Denied
FDA 510(k) Regulatory Record - Datex Division Instrumentarium Corp.
Neurology
✕
2
devices
1-2 of 2
Filters
Cleared
Nov 08, 1984
DUAL CHENNEL BRAIN ACTIVITY MONITOR
K843808
·
OLT
Neurology
·
42d
Cleared
Sep 07, 1982
ANESTHESIA & BRAIN MONITOR
K821910
·
IKN
Neurology
·
71d
Filters
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All
55
Anesthesiology
35
Cardiovascular
18
Neurology
2