510k
Database
Specialties
Anesthesiology
473
Cardiovascular
1430
Chemistry
335
Dental
1127
Ear, Nose, Throat
210
Gastroenterology & Urology
838
General & Plastic Surgery
1888
General Hospital
1421
Hematology
125
Immunology
87
Medical Genetics
8
Microbiology
426
Neurology
811
Obstetrics & Gynecology
360
Ophthalmic
236
Orthopedic
2471
Pathology
49
Physical Medicine
434
Radiology
2057
Toxicology
145
Categories
GEX
Powered Laser Surgical Instrument
306
LLZ
System, Image Processing,...
304
LZA
Polymer Patient Examination Glove
273
GEI
Electrosurgical, Cutting &...
260
QIH
Automated Radiological Image...
255
IYN
System, Imaging, Pulsed Doppler,...
246
HRS
Plate, Fixation, Bone
244
OLO
Orthopedic Stereotaxic Instrument
203
NHA
Abutment, Implant, Dental,...
191
MAX
Intervertebral Fusion Device...
171
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Graphic Controls Corp.
Medical Device Manufacturer
·
US , Mchenry , IL
Graphic Controls Corp. - FDA 510(k) Cleared Devices
55 submissions
·
55 cleared
·
Since 1977
55
Total
55
Cleared
0
Denied
FDA 510(k) Regulatory Record - Graphic Controls Corp.
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 27, 1997
POINT OF USE II SHARPS-A-GATOR
K964387
·
MMK
General Hospital
·
143d
Cleared
Mar 15, 1993
LIFE TRACE(R) BILIRUBIN MASK
K926118
·
FOK
General Hospital
·
102d
Cleared
Sep 19, 1989
MEDI-TRACE ACCU-NATE DEVICE
K891193
·
FPA
General Hospital
·
197d
Filters
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All
55
Cardiovascular
32
Obstetrics & Gynecology
11
Neurology
7
General Hospital
3
Radiology
1
General & Plastic Surgery
1