510k
Database
Specialties
Anesthesiology
545
Cardiovascular
1699
Chemistry
374
Dental
1351
Ear, Nose, Throat
250
Gastroenterology & Urology
979
General & Plastic Surgery
2213
General Hospital
2062
Hematology
126
Immunology
100
Medical Genetics
8
Microbiology
474
Neurology
980
Obstetrics & Gynecology
438
Ophthalmic
282
Orthopedic
2988
Pathology
52
Physical Medicine
515
Radiology
2468
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
414
LLZ
System, Image Processing,...
398
GEX
Powered Laser Surgical Instrument
363
FXX
Mask, Surgical
358
GEI
Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
284
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
224
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UC-CARE , Ltd.
Medical Device Manufacturer
·
US , Washington , DC
UC-CARE , Ltd. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2009
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - UC-CARE , Ltd.
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Aug 07, 2025
Navigo Workstation 2.3 (FPRMC00039)
K250664
·
LLZ
Radiology
·
155d
Cleared
Jan 16, 2018
Navigo Workstation Version 2.0
K173054
·
LLZ
Radiology
·
110d
Cleared
Feb 06, 2017
UC-CARE NaviGo Workstation
K160934
·
LLZ
Radiology
·
308d
Cleared
Nov 01, 2011
UC-CARE NAVIGO SYTEM
K100784
·
LLZ
Radiology
·
592d
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5
Radiology
4
General & Plastic Surgery
1