510k
Database
Specialties
Anesthesiology
486
Cardiovascular
1476
Chemistry
342
Dental
1163
Ear, Nose, Throat
216
Gastroenterology & Urology
855
General & Plastic Surgery
1932
General Hospital
1473
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
432
Neurology
835
Obstetrics & Gynecology
369
Ophthalmic
250
Orthopedic
2545
Pathology
49
Physical Medicine
454
Radiology
2096
Toxicology
147
Categories
GEX
Powered Laser Surgical Instrument
315
LLZ
System, Image Processing,...
308
LZA
Polymer Patient Examination Glove
286
GEI
Electrosurgical, Cutting &...
268
QIH
Automated Radiological Image...
259
HRS
Plate, Fixation, Bone
249
IYN
System, Imaging, Pulsed Doppler,...
248
OLO
Orthopedic Stereotaxic Instrument
209
NHA
Abutment, Implant, Dental,...
198
MAX
Intervertebral Fusion Device...
176
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Friatec Medical Inc., USA
Medical Device Manufacturer
·
US , Potomac , MD
Friatec Medical Inc., USA - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1994
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Friatec Medical Inc., USA
Dental
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 15, 1996
FRIALIT(R)-2 STEPPED SCREW WITH DEEP PROFILE SURFACE
K945847
·
DZE
Dental
·
471d
Cleared
Mar 15, 1996
FRIALIT(R)-2 DENTAL IMPLANT
K945848
·
DZE
Dental
·
471d
Cleared
Mar 15, 1996
FRIALIT(R)-2 STEPPED CYLINDER WITH FRIOS(R) TI-COATING
K945849
·
DZE
Dental
·
471d
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4
Dental
3
Orthopedic
1