510k
Database
Specialties
Anesthesiology
487
Cardiovascular
1478
Chemistry
342
Dental
1165
Ear, Nose, Throat
216
Gastroenterology & Urology
856
General & Plastic Surgery
1936
General Hospital
1477
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
432
Neurology
839
Obstetrics & Gynecology
369
Ophthalmic
250
Orthopedic
2550
Pathology
49
Physical Medicine
454
Radiology
2105
Toxicology
147
Categories
GEX
Powered Laser Surgical Instrument
315
LLZ
System, Image Processing,...
308
LZA
Polymer Patient Examination Glove
286
GEI
Electrosurgical, Cutting &...
269
QIH
Automated Radiological Image...
260
IYN
System, Imaging, Pulsed Doppler,...
253
HRS
Plate, Fixation, Bone
250
OLO
Orthopedic Stereotaxic Instrument
209
NHA
Abutment, Implant, Dental,...
198
MAX
Intervertebral Fusion Device...
177
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Syntex Corp.
Medical Device Manufacturer
·
US , Mchenry , IL
Syntex Corp. - FDA 510(k) Cleared Devices
10 submissions
·
10 cleared
·
Since 1976
10
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Syntex Corp.
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Jun 02, 1978
S-100 CT SCANNER
K780769
·
JAK
Radiology
·
28d
Cleared
Dec 30, 1976
SYNTEX SYSTEM 6000
K761330
·
JAK
Radiology
·
3d
Cleared
Dec 30, 1976
HI-SENSITIVITY MODE OPTION FOR S60-1A
K761332
·
JAK
Radiology
·
3d
Cleared
Nov 24, 1976
COMPUTERIZED TOMOGRAPHY SCANNER
K761033
·
JAK
Radiology
·
9d
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10
Radiology
4
Dental
4
Toxicology
1
General & Plastic Surgery
1