510k
Database
Specialties
Anesthesiology
527
Cardiovascular
1636
Chemistry
358
Dental
1304
Ear, Nose, Throat
239
Gastroenterology & Urology
947
General & Plastic Surgery
2157
General Hospital
2023
Hematology
126
Immunology
95
Medical Genetics
8
Microbiology
459
Neurology
949
Obstetrics & Gynecology
430
Ophthalmic
272
Orthopedic
2796
Pathology
52
Physical Medicine
515
Radiology
2371
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
376
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
297
IYN
System, Imaging, Pulsed Doppler,...
279
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
220
NHA
Abutment, Implant, Dental,...
205
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Ceramatec, Inc.
Medical Device Manufacturer
·
US , Salt Lake City , UT
Ceramatec, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1988
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ceramatec, Inc.
Anesthesiology
✕
4
devices
1-4 of 4
Filters
Cleared
Mar 30, 1998
CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORS
K972992
·
CCL
Anesthesiology
·
230d
Cleared
Mar 04, 1998
HANDI OXYGEN ANALYZER
K973282
·
CCL
Anesthesiology
·
183d
Cleared
Jun 18, 1991
CERION HAND HELD OXYGEN ANALYZER
K911344
·
CCL
Anesthesiology
·
83d
Cleared
Mar 21, 1988
CERION OXY THRESHOLD ALARM
K880448
·
CCL
Anesthesiology
·
48d
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Anesthesiology
4