510k
Database
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338
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1073
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272
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822
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149
Gastroenterology & Urology
636
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1334
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768
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100
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72
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1
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367
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589
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247
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155
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2062
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40
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311
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1591
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132
Categories
GEX
Powered Laser Surgical Instrument
231
HRS
Plate, Fixation, Bone
211
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System, Imaging, Pulsed Doppler,...
209
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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...
137
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Acuderm, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Acuderm, Inc. - FDA 510(k) Cleared Devices
13 submissions
·
13 cleared
·
Since 1983
13
Total
13
Cleared
0
Denied
FDA 510(k) Regulatory Record - Acuderm, Inc.
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Feb 09, 1994
ACU-EVAC
K930043
·
FYD
General Hospital
·
400d
Cleared
Nov 23, 1987
ACU-MICRO-NEEDLE
K874024
·
FMI
General Hospital
·
52d
Cleared
Feb 19, 1986
ACU-SYRINGE W/WO NEEDLES
K854877
·
FMF
General Hospital
·
75d
Filters
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13
General & Plastic Surgery
6
General Hospital
3
Microbiology
3
Pathology
1