510k
Database
Specialties
Anesthesiology
435
Cardiovascular
1325
Chemistry
327
Dental
1018
Ear, Nose, Throat
192
Gastroenterology & Urology
787
General & Plastic Surgery
1730
General Hospital
1129
Hematology
117
Immunology
83
Medical Genetics
7
Microbiology
413
Neurology
740
Obstetrics & Gynecology
326
Ophthalmic
201
Orthopedic
2381
Pathology
44
Physical Medicine
397
Radiology
1922
Toxicology
141
Categories
GEX
Powered Laser Surgical Instrument
285
LLZ
System, Image Processing,...
272
QIH
Automated Radiological Image...
247
GEI
Electrosurgical, Cutting &...
243
IYN
System, Imaging, Pulsed Doppler,...
235
HRS
Plate, Fixation, Bone
232
OLO
Orthopedic Stereotaxic Instrument
195
NHA
Abutment, Implant, Dental,...
182
LZA
Polymer Patient Examination Glove
176
MAX
Intervertebral Fusion Device...
165
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Cares Built, Inc.
Medical Device Manufacturer
·
US , Keyport , NJ
Cares Built, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2001
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Cares Built, Inc.
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Oct 01, 2001
SOLID STATE X-RAY IMAGING DEVICES
K003238
·
MQB
Radiology
·
349d
Cleared
Mar 12, 2001
ATLAS MULTI-PURPOSE DSA SYSTEM
K010391
·
IZI
Radiology
·
31d
Cleared
Mar 12, 2001
ATHENA REMOTE CONTROLLED RF SYSTEM
K010392
·
JAA
Radiology
·
32d
Cleared
Mar 12, 2001
APOLLO MOBILE C ARM SYSTEM
K010393
·
OXO
Radiology
·
32d
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4
Radiology
4