510k
Database
Specialties
Anesthesiology
384
Cardiovascular
1195
Chemistry
290
Dental
888
Ear, Nose, Throat
164
Gastroenterology & Urology
702
General & Plastic Surgery
1513
General Hospital
890
Hematology
108
Immunology
78
Medical Genetics
1
Microbiology
390
Neurology
659
Obstetrics & Gynecology
280
Ophthalmic
173
Orthopedic
2187
Pathology
41
Physical Medicine
355
Radiology
1744
Toxicology
137
Categories
GEX
Powered Laser Surgical Instrument
252
QIH
Automated Radiological Image...
230
LLZ
System, Image Processing,...
226
IYN
System, Imaging, Pulsed Doppler,...
221
HRS
Plate, Fixation, Bone
217
GEI
Electrosurgical, Cutting &...
211
OLO
Orthopedic Stereotaxic Instrument
181
NHA
Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
148
MAX
Intervertebral Fusion Device...
146
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Orfit Industries
Medical Device Manufacturer
·
BE , Wijnegem, Belgium
Orfit Industries - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 1999
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Orfit Industries
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Nov 09, 2015
Thermofit
K151946
·
IYE
Radiology
·
118d
Cleared
Sep 21, 1999
RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS
K991319
·
IYE
Radiology
·
155d
Filters
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2
Radiology
2