510k
Database
Specialties
Anesthesiology
325
Cardiovascular
1044
Chemistry
264
Dental
783
Ear, Nose, Throat
147
Gastroenterology & Urology
607
General & Plastic Surgery
1280
General Hospital
733
Hematology
97
Immunology
72
Medical Genetics
1
Microbiology
363
Neurology
552
Obstetrics & Gynecology
240
Ophthalmic
148
Orthopedic
1984
Pathology
38
Physical Medicine
307
Radiology
1546
Toxicology
128
Categories
GEX
Powered Laser Surgical Instrument
226
IYN
System, Imaging, Pulsed Doppler,...
205
HRS
Plate, Fixation, Bone
204
QIH
Automated Radiological Image...
202
LLZ
System, Image Processing,...
191
GEI
Electrosurgical, Cutting &...
179
OLO
Orthopedic Stereotaxic Instrument
166
NHA
Abutment, Implant, Dental,...
151
MAX
Intervertebral Fusion Device...
136
NKB
Thoracolumbosacral Pedicle Screw...
130
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Healgen Scientific, LLC
Medical Device Manufacturer
·
US , Houston , TX
Healgen Scientific, LLC - FDA 510(k) Cleared Devices
27 submissions
·
27 cleared
·
Since 2012
Official Website
27
Total
27
Cleared
0
Denied
27
devices
26-27 of 27
Filters
1
2
Cleared
Apr 10, 2013
HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY...
K123703
·
LCX
Chemistry
·
128d
Cleared
Apr 17, 2012
HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR...
K111999
·
JIO
Chemistry
·
279d
1
2
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27
Toxicology
14
Chemistry
10
Microbiology
3