510k
Database
Specialties
Anesthesiology
330
Cardiovascular
1055
Chemistry
268
Dental
793
Ear, Nose, Throat
148
Gastroenterology & Urology
619
General & Plastic Surgery
1307
General Hospital
746
Hematology
97
Immunology
72
Medical Genetics
1
Microbiology
364
Neurology
566
Obstetrics & Gynecology
240
Ophthalmic
154
Orthopedic
2032
Pathology
38
Physical Medicine
309
Radiology
1570
Toxicology
130
Categories
GEX
Powered Laser Surgical Instrument
227
HRS
Plate, Fixation, Bone
208
IYN
System, Imaging, Pulsed Doppler,...
207
QIH
Automated Radiological Image...
204
LLZ
System, Image Processing,...
197
GEI
Electrosurgical, Cutting &...
185
OLO
Orthopedic Stereotaxic Instrument
168
NHA
Abutment, Implant, Dental,...
153
MAX
Intervertebral Fusion Device...
137
NKB
Thoracolumbosacral Pedicle Screw...
133
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Hana Biologics, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Hana Biologics, Inc. - FDA 510(k) Cleared Devices
8 submissions
·
8 cleared
·
Since 1981
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hana Biologics, Inc.
Microbiology
✕
4
devices
1-4 of 4
Filters
Cleared
Feb 05, 1986
MYCOTRIM TM VL TRIPHASIC CULTURE SYSTEM
K855205
·
JSI
Microbiology
·
37d
Cleared
May 25, 1984
AMNIO STAT-FLM AGGLUTINATION TEST
K834616
·
JHG
Microbiology
·
163d
Cleared
Dec 03, 1982
MYCOTRIUM-GU
K822736
·
JSI
Microbiology
·
85d
Cleared
Dec 03, 1982
MYCOTRIUM-RS
K822737
·
JSI
Microbiology
·
85d
Filters
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8
Microbiology
4
Pathology
2
Hematology
1
Chemistry
1