510k
Database
Specialties
Anesthesiology
490
Cardiovascular
1491
Chemistry
343
Dental
1173
Ear, Nose, Throat
216
Gastroenterology & Urology
859
General & Plastic Surgery
1940
General Hospital
1488
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
433
Neurology
848
Obstetrics & Gynecology
369
Ophthalmic
250
Orthopedic
2564
Pathology
49
Physical Medicine
455
Radiology
2120
Toxicology
148
Categories
GEX
Powered Laser Surgical Instrument
317
LLZ
System, Image Processing,...
312
LZA
Polymer Patient Examination Glove
286
GEI
Electrosurgical, Cutting &...
270
QIH
Automated Radiological Image...
262
IYN
System, Imaging, Pulsed Doppler,...
254
HRS
Plate, Fixation, Bone
251
OLO
Orthopedic Stereotaxic Instrument
213
NHA
Abutment, Implant, Dental,...
199
MAX
Intervertebral Fusion Device...
178
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Concept, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Concept, Inc. - FDA 510(k) Cleared Devices
83 submissions
·
82 cleared
·
Since 1976
83
Total
82
Cleared
0
Denied
FDA 510(k) Regulatory Record - Concept, Inc.
Anesthesiology
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 04, 1984
TUBE-STAT
K843490
·
BSR
Anesthesiology
·
28d
Cleared
May 28, 1980
CONCEPT ENDOTRACHEAL TUBE
K801213
·
BTR
Anesthesiology
·
8d
Cleared
Aug 22, 1979
RESUSCI-BAG-VALVE
K791468
·
BTM
Anesthesiology
·
16d
Filters
Filter by Specialty
All
83
General & Plastic Surgery
32
Orthopedic
22
Ophthalmic
9
Gastroenterology & Urology
5
General Hospital
4
Cardiovascular
3
Anesthesiology
3
Ear, Nose, Throat
2
Dental
1
Neurology
1