510k
Database
Specialties
Anesthesiology
4806
Cardiovascular
11753
Chemistry
10253
Dental
7486
Ear, Nose, Throat
2310
Gastroenterology & Urology
6157
General & Plastic Surgery
10243
General Hospital
8478
Hematology
2336
Immunology
2902
Medical Genetics
18
Microbiology
5483
Neurology
3520
Obstetrics & Gynecology
2288
Ophthalmic
1909
Orthopedic
14033
Pathology
787
Physical Medicine
2011
Radiology
9531
Toxicology
2407
Categories
GEX
Powered Laser Surgical Instrument
1752
GEI
Electrosurgical, Cutting &...
1404
LLZ
System, Image Processing,...
1272
HRS
Plate, Fixation, Bone
1054
IYN
System, Imaging, Pulsed Doppler,...
945
DZE
Implant, Endosseous, Root-form
889
ESD
Hearing Aid, Air-conduction,...
882
LNH
System, Nuclear Magnetic...
876
GCJ
Laparoscope, General & Plastic...
860
JWH
Prosthesis, Knee,...
847
Browse all 339 categories →
Manufacturers
Search
Reports
Glossary
About
Search FDA 510(k) devices
510k Database
Manufacturers
US
Hemosphere, Inc.
Medical Device Manufacturer
·
US , Eden Prarie , MN
Hemosphere, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2009
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hemosphere, Inc.
Cardiovascular
✕
3
devices
1-3 of 3
Filters
Cleared
Jun 22, 2012
HERO GRAFT
K121532
·
DSY
Cardiovascular
·
29d
Cleared
Feb 02, 2012
HERO GRAFT
K120006
·
DSY
Cardiovascular
·
30d
Cleared
Jul 31, 2009
HERO VASCULAR ACCESS DEVICE
K091491
·
DSY
Cardiovascular
·
72d
Filters
Filter by Specialty
All
3
Cardiovascular
3