510k
Database
Specialties
Anesthesiology
512
Cardiovascular
1593
Chemistry
356
Dental
1285
Ear, Nose, Throat
234
Gastroenterology & Urology
922
General & Plastic Surgery
2114
General Hospital
1899
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
932
Obstetrics & Gynecology
422
Ophthalmic
267
Orthopedic
2684
Pathology
52
Physical Medicine
507
Radiology
2300
Toxicology
154
Categories
LZA
Polymer Patient Examination Glove
392
LLZ
System, Image Processing,...
360
GEX
Powered Laser Surgical Instrument
348
FXX
Mask, Surgical
295
GEI
Electrosurgical, Cutting &...
292
QIH
Automated Radiological Image...
272
IYN
System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
261
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
204
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Medel S.P.A.
Medical Device Manufacturer
·
US , Cary , NC
Medel S.P.A. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2006
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Medel S.P.A.
Anesthesiology
✕
3
devices
1-3 of 3
Filters
Cleared
Feb 12, 2008
AG-CLASSIC
K072494
·
CAF
Anesthesiology
·
160d
Cleared
Jan 08, 2007
AG-EDGE, MODEL 91200
K063103
·
CAF
Anesthesiology
·
90d
Cleared
Jun 22, 2006
AG-PLUS, MODEL 91210
K060404
·
CAF
Anesthesiology
·
127d
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4
Anesthesiology
3
Obstetrics & Gynecology
1