510k
Database
Specialties
Anesthesiology
133
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569
Chemistry
164
Dental
314
Ear, Nose, Throat
68
Gastroenterology & Urology
288
General & Plastic Surgery
516
General Hospital
373
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
233
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167
Obstetrics & Gynecology
61
Ophthalmic
49
Orthopedic
1293
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18
Physical Medicine
86
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870
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
MBI
Fastener, Fixation,...
85
NHA
Abutment, Implant, Dental,...
84
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Opgen, Inc.
Medical Device Manufacturer
·
US , Rockville , MD
Opgen, Inc. - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2021
1
Total
1
Cleared
0
Denied
FDA 510(k) cleared devices by Opgen, Inc.
Microbiology
✕
1
devices
1-1 of 1
Filters
Cleared
Sep 30, 2021
Acuitas AMR Gene Panel
K191288
·
PMY
Microbiology
·
871d
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1
Microbiology
1