510k
Database
Specialties
Anesthesiology
471
Cardiovascular
1415
Chemistry
334
Dental
1117
Ear, Nose, Throat
208
Gastroenterology & Urology
835
General & Plastic Surgery
1872
General Hospital
1374
Hematology
124
Immunology
87
Medical Genetics
8
Microbiology
423
Neurology
806
Obstetrics & Gynecology
354
Ophthalmic
232
Orthopedic
2467
Pathology
48
Physical Medicine
429
Radiology
2039
Toxicology
144
Categories
GEX
Powered Laser Surgical Instrument
305
LLZ
System, Image Processing,...
301
GEI
Electrosurgical, Cutting &...
258
QIH
Automated Radiological Image...
255
LZA
Polymer Patient Examination Glove
252
IYN
System, Imaging, Pulsed Doppler,...
245
HRS
Plate, Fixation, Bone
243
OLO
Orthopedic Stereotaxic Instrument
203
NHA
Abutment, Implant, Dental,...
190
MAX
Intervertebral Fusion Device...
171
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Parexel Intl. Corp.
Medical Device Manufacturer
·
US , Mchenry , IL
Parexel Intl. Corp. - FDA 510(k) Cleared Devices
14 submissions
·
14 cleared
·
Since 1984
14
Total
14
Cleared
0
Denied
FDA 510(k) Regulatory Record - Parexel Intl. Corp.
Dental
✕
2
devices
1-2 of 2
Filters
Cleared
Jul 31, 1984
NATURA-TONE OR LUXOPAL CL ACRYLIC
K842208
·
ELM
Dental
·
57d
Cleared
Jul 12, 1984
NATURA-DENT VACUUM-FIRED PORCELAIN TEETH
K841826
·
ELL
Dental
·
71d
Filters
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14
Radiology
6
Cardiovascular
4
Dental
2
General & Plastic Surgery
1
General Hospital
1