510k
Database
Specialties
Anesthesiology
546
Cardiovascular
1711
Chemistry
380
Dental
1356
Ear, Nose, Throat
252
Gastroenterology & Urology
982
General & Plastic Surgery
2217
General Hospital
2082
Hematology
126
Immunology
100
Medical Genetics
8
Microbiology
474
Neurology
980
Obstetrics & Gynecology
441
Ophthalmic
283
Orthopedic
3030
Pathology
52
Physical Medicine
515
Radiology
2489
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
416
LLZ
System, Image Processing,...
400
GEX
Powered Laser Surgical Instrument
363
FXX
Mask, Surgical
359
GEI
Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
304
HRS
Plate, Fixation, Bone
291
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
236
MAX
Intervertebral Fusion Device...
232
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Greiner Bio-One North America, Inc.
Medical Device Manufacturer
·
US , Baldwin , MD
Greiner Bio-One North America, Inc. - FDA 510(k) Cleared Devices
10 submissions
·
10 cleared
·
Since 2006
10
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Greiner Bio-One North America, Inc.
Chemistry
✕
3
devices
1-3 of 3
Filters
Cleared
Jan 10, 2013
BLOOD CULTURE HOLDER
K122687
·
JKA
Chemistry
·
128d
Cleared
Nov 09, 2010
VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR
K103041
·
JKA
Chemistry
·
26d
Cleared
Dec 16, 2008
VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR
K081929
·
JKA
Chemistry
·
162d
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6
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1