510k
Database
Specialties
Anesthesiology
411
Cardiovascular
1247
Chemistry
309
Dental
950
Ear, Nose, Throat
181
Gastroenterology & Urology
735
General & Plastic Surgery
1604
General Hospital
991
Hematology
113
Immunology
80
Medical Genetics
6
Microbiology
402
Neurology
695
Obstetrics & Gynecology
303
Ophthalmic
186
Orthopedic
2261
Pathology
43
Physical Medicine
377
Radiology
1819
Toxicology
138
Categories
GEX
Powered Laser Surgical Instrument
266
LLZ
System, Image Processing,...
255
QIH
Automated Radiological Image...
236
GEI
Electrosurgical, Cutting &...
225
IYN
System, Imaging, Pulsed Doppler,...
225
HRS
Plate, Fixation, Bone
222
OLO
Orthopedic Stereotaxic Instrument
186
NHA
Abutment, Implant, Dental,...
171
NKB
Thoracolumbosacral Pedicle Screw...
154
MAX
Intervertebral Fusion Device...
149
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Contour Fabricators, Inc.
Medical Device Manufacturer
·
US , Fenton , MI
Contour Fabricators, Inc. - FDA 510(k) Cleared Devices
8 submissions
·
8 cleared
·
Since 1979
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Contour Fabricators, Inc.
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Apr 10, 1997
STERILE DISPOSABLE EQUIPMENT MAGNET COVER
K970185
·
KKX
General Hospital
·
83d
Cleared
Nov 15, 1996
CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046)
K963453
·
FMQ
General Hospital
·
73d
Cleared
May 03, 1982
BANDBAG, WRAP, STERILE
K820692
·
MMP
General Hospital
·
52d
Filters
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8
General Hospital
3
Radiology
3
General & Plastic Surgery
2