510k
Database
Specialties
Anesthesiology
545
Cardiovascular
1693
Chemistry
370
Dental
1351
Ear, Nose, Throat
250
Gastroenterology & Urology
979
General & Plastic Surgery
2211
General Hospital
2055
Hematology
126
Immunology
100
Medical Genetics
8
Microbiology
473
Neurology
980
Obstetrics & Gynecology
438
Ophthalmic
280
Orthopedic
2980
Pathology
52
Physical Medicine
515
Radiology
2466
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
411
LLZ
System, Image Processing,...
398
GEX
Powered Laser Surgical Instrument
361
FXX
Mask, Surgical
358
GEI
Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
283
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
224
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Rotek Corp.
Medical Device Manufacturer
·
US , Albuquerque , NM
Rotek Corp. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 1987
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Rotek Corp.
Anesthesiology
✕
2
devices
1-2 of 2
Filters
Cleared
Jan 11, 1991
TRACH COLLAR
K904974
·
CBH
Anesthesiology
·
80d
Cleared
Sep 04, 1987
TRACH COLLAR
K872832
·
CBH
Anesthesiology
·
49d
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Anesthesiology
2