510k
Database
Specialties
Anesthesiology
493
Cardiovascular
1526
Chemistry
348
Dental
1202
Ear, Nose, Throat
222
Gastroenterology & Urology
884
General & Plastic Surgery
2004
General Hospital
1547
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
437
Neurology
870
Obstetrics & Gynecology
386
Ophthalmic
254
Orthopedic
2608
Pathology
49
Physical Medicine
471
Radiology
2178
Toxicology
153
Categories
GEX
Powered Laser Surgical Instrument
326
LLZ
System, Image Processing,...
322
LZA
Polymer Patient Examination Glove
297
GEI
Electrosurgical, Cutting &...
279
QIH
Automated Radiological Image...
264
IYN
System, Imaging, Pulsed Doppler,...
261
HRS
Plate, Fixation, Bone
254
OLO
Orthopedic Stereotaxic Instrument
215
NHA
Abutment, Implant, Dental,...
201
MAX
Intervertebral Fusion Device...
187
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Gambro, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Gambro, Inc. - FDA 510(k) Cleared Devices
86 submissions
·
86 cleared
·
Since 1976
86
Total
86
Cleared
0
Denied
FDA 510(k) Regulatory Record - Gambro, Inc.
Hematology
✕
1
devices
1-1 of 1
Filters
Cleared
Oct 31, 1980
GAMBRO HEMOFREEZE-BAG
K801082
·
KSR
Hematology
·
177d
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All
86
Gastroenterology & Urology
64
Cardiovascular
11
Anesthesiology
5
Orthopedic
2
Hematology
1
Chemistry
1
Dental
1
General Hospital
1