510k
Database
Specialties
Anesthesiology
550
Cardiovascular
1723
Chemistry
386
Dental
1389
Ear, Nose, Throat
256
Gastroenterology & Urology
990
General & Plastic Surgery
2228
General Hospital
2093
Hematology
127
Immunology
104
Medical Genetics
8
Microbiology
474
Neurology
985
Obstetrics & Gynecology
443
Ophthalmic
286
Orthopedic
3061
Pathology
52
Physical Medicine
515
Radiology
2505
Toxicology
156
Categories
LZA
Polymer Patient Examination Glove
418
LLZ
System, Image Processing,...
401
GEX
Powered Laser Surgical Instrument
364
FXX
Mask, Surgical
359
GEI
Electrosurgical, Cutting &...
310
IYN
System, Imaging, Pulsed Doppler,...
305
HRS
Plate, Fixation, Bone
298
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
236
MAX
Intervertebral Fusion Device...
234
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Concord Laboratories, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Concord Laboratories, Inc. - FDA 510(k) Cleared Devices
42 submissions
·
38 cleared
·
Since 1976
Official Website
42
Total
38
Cleared
0
Denied
FDA 510(k) Regulatory Record - Concord Laboratories, Inc.
Hematology
✕
2
devices
1-2 of 2
Filters
Cleared
Oct 13, 1977
BLOOD GAS TRAY #4024
K771667
·
FMI
Hematology
·
43d
Cleared
Jul 16, 1976
TRAY, BLOOD SAMPLING (PULSATOR II)
K760086
·
GJE
Hematology
·
25d
Filters
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42
General Hospital
13
Gastroenterology & Urology
12
Anesthesiology
11
General & Plastic Surgery
3
Hematology
2
Microbiology
1