510k
Database
Specialties
Anesthesiology
491
Cardiovascular
1496
Chemistry
343
Dental
1182
Ear, Nose, Throat
216
Gastroenterology & Urology
860
General & Plastic Surgery
1944
General Hospital
1503
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
433
Neurology
853
Obstetrics & Gynecology
370
Ophthalmic
251
Orthopedic
2568
Pathology
49
Physical Medicine
456
Radiology
2132
Toxicology
149
Categories
GEX
Powered Laser Surgical Instrument
318
LLZ
System, Image Processing,...
315
LZA
Polymer Patient Examination Glove
288
GEI
Electrosurgical, Cutting &...
270
QIH
Automated Radiological Image...
262
IYN
System, Imaging, Pulsed Doppler,...
256
HRS
Plate, Fixation, Bone
251
OLO
Orthopedic Stereotaxic Instrument
213
NHA
Abutment, Implant, Dental,...
200
MAX
Intervertebral Fusion Device...
180
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Simpex, Inc.
Medical Device Manufacturer
·
US , Beaverton , OR
Simpex, Inc. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 1991
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Simpex, Inc.
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 12, 1991
FIXATION PIN
K911452
·
HTY
Orthopedic
·
9d
Cleared
Apr 12, 1991
FIXATION WIRE
K911505
·
HTY
Orthopedic
·
8d
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5
Orthopedic
2
General Hospital
2
General & Plastic Surgery
1