510k
Database
Specialties
Anesthesiology
332
Cardiovascular
1058
Chemistry
268
Dental
800
Ear, Nose, Throat
148
Gastroenterology & Urology
621
General & Plastic Surgery
1318
General Hospital
748
Hematology
97
Immunology
72
Medical Genetics
1
Microbiology
365
Neurology
573
Obstetrics & Gynecology
243
Ophthalmic
155
Orthopedic
2044
Pathology
39
Physical Medicine
309
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1580
Toxicology
132
Categories
GEX
Powered Laser Surgical Instrument
227
HRS
Plate, Fixation, Bone
209
IYN
System, Imaging, Pulsed Doppler,...
208
QIH
Automated Radiological Image...
205
LLZ
System, Image Processing,...
199
GEI
Electrosurgical, Cutting &...
185
OLO
Orthopedic Stereotaxic Instrument
168
NHA
Abutment, Implant, Dental,...
155
MAX
Intervertebral Fusion Device...
137
NKB
Thoracolumbosacral Pedicle Screw...
135
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Acufex Microsurgical, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Acufex Microsurgical, Inc. - FDA 510(k) Cleared Devices
78 submissions
·
75 cleared
·
Since 1980
78
Total
75
Cleared
0
Denied
FDA 510(k) Regulatory Record - Acufex Microsurgical, Inc.
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Jun 22, 1993
FLUORO-SHIELD RADIATION REDUCTION GLOVES
K920620
·
LZC
General Hospital
·
497d
Cleared
Feb 13, 1990
FLOUROSHIELD RADIATION REDUCTION GLOVE
K893093
·
LZC
General Hospital
·
306d
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78
Orthopedic
56
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16
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2
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1
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1
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1
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1