510k
Database
Specialties
Anesthesiology
198
Cardiovascular
719
Chemistry
185
Dental
446
Ear, Nose, Throat
86
Gastroenterology & Urology
382
General & Plastic Surgery
747
General Hospital
460
Hematology
74
Immunology
61
Medical Genetics
1
Microbiology
271
Neurology
286
Obstetrics & Gynecology
111
Ophthalmic
74
Orthopedic
1463
Pathology
26
Physical Medicine
145
Radiology
1066
Toxicology
93
Categories
IYN
System, Imaging, Pulsed Doppler,...
161
HRS
Plate, Fixation, Bone
150
OLO
Orthopedic Stereotaxic Instrument
128
LLZ
System, Image Processing,...
122
GEX
Powered Laser Surgical Instrument
121
QIH
Automated Radiological Image...
106
NHA
Abutment, Implant, Dental,...
103
GEI
Electrosurgical, Cutting &...
103
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Global Instrumentation, LLC
Medical Device Manufacturer
·
US , Manlius , NY
Global Instrumentation, LLC - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2005
4
Total
4
Cleared
0
Denied
FDA 510(k) cleared devices by Global Instrumentation, LLC
Cardiovascular
✕
4
devices
1-4 of 4
Filters
Cleared
Dec 29, 2020
M5 Recorder
K202456
·
DSH
Cardiovascular
·
124d
Cleared
May 24, 2017
Matrix Data Management System
K162463
·
DXN
Cardiovascular
·
264d
Cleared
Apr 22, 2016
Matrix Mini ECG Monitor
K152701
·
DSI
Cardiovascular
·
214d
Cleared
Sep 26, 2005
MATRIX HOLTER SYSTEM, MODEL M12
K051730
·
MLO
Cardiovascular
·
91d
Filters
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4
Cardiovascular
4