510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1684
Chemistry
370
Dental
1342
Ear, Nose, Throat
250
Gastroenterology & Urology
979
General & Plastic Surgery
2202
General Hospital
2052
Hematology
126
Immunology
100
Medical Genetics
8
Microbiology
472
Neurology
973
Obstetrics & Gynecology
436
Ophthalmic
279
Orthopedic
2968
Pathology
52
Physical Medicine
515
Radiology
2458
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
391
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
282
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
221
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Gish Biomedical, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Gish Biomedical, Inc. - FDA 510(k) Cleared Devices
75 submissions
·
75 cleared
·
Since 1983
75
Total
75
Cleared
0
Denied
FDA 510(k) Regulatory Record - Gish Biomedical, Inc.
Anesthesiology
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 08, 1991
ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEM
K912019
·
CAC
Anesthesiology
·
154d
Cleared
Nov 08, 1989
BLOOD RECOVERY/AUTOTRANSFUSION RESERVOIR ATR-2900
K892443
·
CAC
Anesthesiology
·
212d
Cleared
Dec 05, 1986
DURACATH, GISH MODEL NO. DVAC-XXXX
K863792
·
BSO
Anesthesiology
·
70d
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All
75
Cardiovascular
61
General Hospital
7
Anesthesiology
3
General & Plastic Surgery
2
Toxicology
1
Gastroenterology & Urology
1