510k
Database
Specialties
Anesthesiology
338
Cardiovascular
1073
Chemistry
272
Dental
824
Ear, Nose, Throat
149
Gastroenterology & Urology
637
General & Plastic Surgery
1338
General Hospital
771
Hematology
100
Immunology
72
Medical Genetics
1
Microbiology
367
Neurology
589
Obstetrics & Gynecology
247
Ophthalmic
155
Orthopedic
2063
Pathology
40
Physical Medicine
311
Radiology
1592
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,...
161
MAX
Intervertebral Fusion Device...
138
NKB
Thoracolumbosacral Pedicle Screw...
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
General & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
Feb 17, 2017
ExpressBraid Graft Manipulation
K163651
·
GAT
General & Plastic Surgery
·
56d
Cleared
Feb 08, 2016
ExpressBraid Graft Manipulation
K152868
·
GAT
General & Plastic Surgery
·
131d
Cleared
Jun 20, 2007
MESOSFOL SURGICAL FILM
K062558
·
FTM
General & Plastic Surgery
·
294d
Filters
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All
93
Orthopedic
87
General & Plastic Surgery
3
Hematology
1
Neurology
1
Radiology
1