510k
Database
Specialties
Anesthesiology
117
Cardiovascular
507
Chemistry
156
Dental
276
Ear, Nose, Throat
59
Gastroenterology & Urology
258
General & Plastic Surgery
439
General Hospital
339
Hematology
63
Immunology
55
Medical Genetics
0
Microbiology
221
Neurology
133
Obstetrics & Gynecology
43
Ophthalmic
41
Orthopedic
1214
Pathology
18
Physical Medicine
58
Radiology
789
Toxicology
86
Categories
IYN
System, Imaging, Pulsed Doppler,...
145
HRS
Plate, Fixation, Bone
123
OLO
Orthopedic Stereotaxic Instrument
108
LLZ
System, Image Processing,...
93
MAX
Intervertebral Fusion Device...
80
NHA
Abutment, Implant, Dental,...
80
MBI
Fastener, Fixation,...
77
NKB
Thoracolumbosacral Pedicle Screw...
77
LNH
System, Nuclear Magnetic...
76
JAK
System, X-ray, Tomography, Computed
73
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R&D Systems, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
R&D Systems, Inc. - FDA 510(k) Cleared Devices
79 submissions
·
79 cleared
·
Since 1978
79
Total
79
Cleared
0
Denied
FDA 510(k) cleared devices by R&D Systems, Inc.
Chemistry
✕
2
devices
1-2 of 2
Filters
Cleared
Mar 10, 2004
R&D GLU-LINE HEMATOLOGY CONTROL
K034048
·
JJX
Chemistry
·
71d
Cleared
Jun 08, 1983
SPIA SYS FOR SOLID PHASE IMMUNOASSAYS
K831448
·
LIB
Chemistry
·
34d
Filters
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All
79
Hematology
74
Immunology
2
Chemistry
2
Physical Medicine
1