510k
Database
Specialties
Anesthesiology
534
Cardiovascular
1649
Chemistry
359
Dental
1323
Ear, Nose, Throat
243
Gastroenterology & Urology
956
General & Plastic Surgery
2174
General Hospital
2038
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
462
Neurology
954
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2828
Pathology
52
Physical Medicine
515
Radiology
2403
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
381
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
209
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Carbon Medical Technologies, Inc.
Medical Device Manufacturer
·
US , St, Paul , MN
Carbon Medical Technologies, Inc. - FDA 510(k) Cleared Devices
16 submissions
·
16 cleared
·
Since 2002
16
Total
16
Cleared
0
Denied
FDA 510(k) Regulatory Record - Carbon Medical Technologies, Inc.
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Jun 10, 2021
Fiducial Marker
K211590
·
IYE
Radiology
·
17d
Cleared
Feb 28, 2014
BIOMARC FIDUCIAL MARKER
K132064
·
IYE
Radiology
·
240d
Cleared
Apr 12, 2013
BIOMARC GOLD FIDUCIAL MARKER
K130678
·
IYE
Radiology
·
30d
Cleared
Apr 28, 2011
BIOMARC FIDUCIAL MARKER
K110772
·
IYE
Radiology
·
38d
Filters
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16
General & Plastic Surgery
9
Radiology
4
Gastroenterology & Urology
3