510k
Database
Specialties
Anesthesiology
130
Cardiovascular
561
Chemistry
161
Dental
308
Ear, Nose, Throat
67
Gastroenterology & Urology
286
General & Plastic Surgery
510
General Hospital
368
Hematology
66
Immunology
56
Medical Genetics
0
Microbiology
232
Neurology
163
Obstetrics & Gynecology
60
Ophthalmic
49
Orthopedic
1285
Pathology
18
Physical Medicine
84
Radiology
865
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
133
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
98
MBI
Fastener, Fixation,...
84
NHA
Abutment, Implant, Dental,...
83
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
82
NKB
Thoracolumbosacral Pedicle Screw...
80
JAK
System, X-ray, Tomography, Computed
79
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Balt USA, LLC
Medical Device Manufacturer
·
US , Irvine , CA
Balt USA, LLC - FDA 510(k) Cleared Devices
17 submissions
·
17 cleared
·
Since 2018
17
Total
17
Cleared
0
Denied
FDA 510(k) cleared devices by Balt USA, LLC
Cardiovascular
✕
1
devices
1-1 of 1
Filters
Cleared
May 30, 2025
Prestige Coil System (Prestige Packing Line Extension)
K251383
·
KRD
Cardiovascular
·
28d
Filters
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17
Neurology
16
Cardiovascular
1