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.
General Hospital
✕
4
devices
1-4 of 4
Filters
Cleared
Nov 21, 1983
C-FLEX MEDICAL GRADE TUBING
K833076
·
FPK
General Hospital
·
73d
Cleared
Sep 29, 1983
LIGHT HANDLE COVER
K832278
·
KKX
General Hospital
·
79d
Cleared
Jun 22, 1979
PENLIGHT/SWAB HOLDER
K791001
·
KYT
General Hospital
·
24d
Cleared
Mar 30, 1977
SUTURE CUTTER
K770163
·
JOK
General Hospital
·
64d
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