510k
Database
Specialties
Anesthesiology
479
Cardiovascular
1446
Chemistry
337
Dental
1141
Ear, Nose, Throat
210
Gastroenterology & Urology
841
General & Plastic Surgery
1898
General Hospital
1443
Hematology
125
Immunology
89
Medical Genetics
8
Microbiology
426
Neurology
814
Obstetrics & Gynecology
362
Ophthalmic
238
Orthopedic
2486
Pathology
49
Physical Medicine
439
Radiology
2067
Toxicology
145
Categories
GEX
Powered Laser Surgical Instrument
307
LLZ
System, Image Processing,...
305
LZA
Polymer Patient Examination Glove
278
GEI
Electrosurgical, Cutting &...
261
QIH
Automated Radiological Image...
256
HRS
Plate, Fixation, Bone
246
IYN
System, Imaging, Pulsed Doppler,...
246
OLO
Orthopedic Stereotaxic Instrument
204
NHA
Abutment, Implant, Dental,...
191
MAX
Intervertebral Fusion Device...
172
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Mednext, Inc.
Medical Device Manufacturer
·
US , West Point Beach , FL
Mednext, Inc. - FDA 510(k) Cleared Devices
7 submissions
·
7 cleared
·
Since 1993
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Mednext, Inc.
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Feb 28, 1997
MEDNEXT SURGICAL BUR
K970023
·
HWE
Orthopedic
·
56d
Cleared
Jul 22, 1993
MEDNEXT 1000 BONE DISSECTING SYSTEM
K926547
·
HSZ
Orthopedic
·
203d
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7
Neurology
2
Orthopedic
2
Ear, Nose, Throat
2
General & Plastic Surgery
1