510k
Database
Specialties
Anesthesiology
469
Cardiovascular
1409
Chemistry
334
Dental
1112
Ear, Nose, Throat
206
Gastroenterology & Urology
833
General & Plastic Surgery
1860
General Hospital
1351
Hematology
124
Immunology
87
Medical Genetics
7
Microbiology
423
Neurology
797
Obstetrics & Gynecology
353
Ophthalmic
231
Orthopedic
2458
Pathology
48
Physical Medicine
426
Radiology
2035
Toxicology
144
Categories
GEX
Powered Laser Surgical Instrument
301
LLZ
System, Image Processing,...
299
GEI
Electrosurgical, Cutting &...
258
QIH
Automated Radiological Image...
255
IYN
System, Imaging, Pulsed Doppler,...
245
LZA
Polymer Patient Examination Glove
243
HRS
Plate, Fixation, Bone
242
OLO
Orthopedic Stereotaxic Instrument
201
NHA
Abutment, Implant, Dental,...
190
MAX
Intervertebral Fusion Device...
171
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Gibeck, Inc.
Medical Device Manufacturer
·
US , Indianapolis , IN
Gibeck, Inc. - FDA 510(k) Cleared Devices
15 submissions
·
15 cleared
·
Since 1990
15
Total
15
Cleared
0
Denied
FDA 510(k) Regulatory Record - Gibeck, Inc.
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 23, 1997
THERMAL REGULATION SYSTEM BLANKET
K964377
·
DWJ
Cardiovascular
·
173d
Cleared
Jan 13, 1997
GIBECK WARMBAG REUSABLE CONVECTIVE WARMING BLANKET
K960511
·
DWJ
Cardiovascular
·
343d
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15
Anesthesiology
9
General Hospital
3
Cardiovascular
2
Radiology
1