510k
Database
Specialties
Anesthesiology
338
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1075
Chemistry
273
Dental
826
Ear, Nose, Throat
149
Gastroenterology & Urology
639
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1338
General Hospital
776
Hematology
100
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72
Medical Genetics
1
Microbiology
368
Neurology
591
Obstetrics & Gynecology
249
Ophthalmic
157
Orthopedic
2065
Pathology
40
Physical Medicine
312
Radiology
1598
Toxicology
132
Categories
GEX
Powered Laser Surgical Instrument
231
HRS
Plate, Fixation, Bone
211
IYN
System, Imaging, Pulsed Doppler,...
209
QIH
Automated Radiological Image...
208
LLZ
System, Image Processing,...
199
GEI
Electrosurgical, Cutting &...
186
OLO
Orthopedic Stereotaxic Instrument
170
NHA
Abutment, Implant, Dental,...
162
NKB
Thoracolumbosacral Pedicle Screw...
138
MAX
Intervertebral Fusion Device...
138
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Biomet Manufacturing Corp
Medical Device Manufacturer
·
US , Warsaw , IN
Biomet Manufacturing Corp - FDA 510(k) Cleared Devices
93 submissions
·
93 cleared
·
Since 2004
93
Total
93
Cleared
0
Denied
FDA 510(k) Regulatory Record - Biomet Manufacturing Corp
Radiology
✕
1
devices
1-1 of 1
Filters
Cleared
Jul 25, 2023
Patient Specific Planning Solution™ 3D Bone Models
K230540
·
LLZ
Radiology
·
148d
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93
Orthopedic
87
General & Plastic Surgery
3
Hematology
1
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1
Radiology
1