510k
Database
Specialties
Anesthesiology
382
Cardiovascular
1193
Chemistry
289
Dental
884
Ear, Nose, Throat
164
Gastroenterology & Urology
699
General & Plastic Surgery
1508
General Hospital
888
Hematology
108
Immunology
78
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1
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389
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653
Obstetrics & Gynecology
277
Ophthalmic
173
Orthopedic
2183
Pathology
41
Physical Medicine
354
Radiology
1738
Toxicology
137
Categories
GEX
Powered Laser Surgical Instrument
252
QIH
Automated Radiological Image...
229
LLZ
System, Image Processing,...
224
IYN
System, Imaging, Pulsed Doppler,...
221
HRS
Plate, Fixation, Bone
216
GEI
Electrosurgical, Cutting &...
210
OLO
Orthopedic Stereotaxic Instrument
181
NHA
Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
148
MAX
Intervertebral Fusion Device...
146
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Bionix Development Corp.
Medical Device Manufacturer
·
US , Toledo , OH
Bionix Development Corp. - FDA 510(k) Cleared Devices
12 submissions
·
12 cleared
·
Since 1990
12
Total
12
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bionix Development Corp.
General Hospital
✕
1
devices
1-1 of 1
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Cleared
Mar 07, 2013
LITTLE ANGELS SWADDLING BLANKET
K123411
·
PDH
General Hospital
·
122d
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12
Radiology
10
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1
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