510k
Database
Specialties
Anesthesiology
473
Cardiovascular
1417
Chemistry
334
Dental
1119
Ear, Nose, Throat
209
Gastroenterology & Urology
836
General & Plastic Surgery
1874
General Hospital
1385
Hematology
125
Immunology
87
Medical Genetics
8
Microbiology
424
Neurology
808
Obstetrics & Gynecology
355
Ophthalmic
234
Orthopedic
2468
Pathology
48
Physical Medicine
429
Radiology
2049
Toxicology
145
Categories
GEX
Powered Laser Surgical Instrument
305
LLZ
System, Image Processing,...
304
GEI
Electrosurgical, Cutting &...
258
LZA
Polymer Patient Examination Glove
257
QIH
Automated Radiological Image...
255
IYN
System, Imaging, Pulsed Doppler,...
245
HRS
Plate, Fixation, Bone
243
OLO
Orthopedic Stereotaxic Instrument
203
NHA
Abutment, Implant, Dental,...
190
MAX
Intervertebral Fusion Device...
171
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Medcanica, Inc.
Medical Device Manufacturer
·
US , Miami , FL
Medcanica, Inc. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 1999
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Medcanica, Inc.
Cardiovascular
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 12, 2001
INSTRUMENT DAMPING PORT
K011373
·
DRC
Cardiovascular
·
161d
Cleared
Oct 05, 2001
INTERCOSTAL LOCKABLE-DIRECTABLE PORT
K011349
·
DRC
Cardiovascular
·
156d
Cleared
Nov 05, 1999
ULTRA-CBX
K991486
·
DWZ
Cardiovascular
·
191d
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5
Cardiovascular
3
Orthopedic
2